486460-32-6 Slitagliptin COA 中英文双板-Biocar

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1-靶向药物-按照英文名称汇总

伊马替尼
imatinib
伊沙佐米
ixazomib
拉帕替尼
lapatinib
拉罗替尼
larotrectinib
仑伐替尼
乐伐替尼
Lenvatinib
劳拉替你
Lorlatinib
莫立替尼
木利替尼
莫利替尼
Mubritinib
尼罗替尼
尼洛替尼
Nilotinib
尼拉帕尼
Niraparib
来那替你
Niratinib
bortezomib
布吉替尼
布吉他滨
Brigatinib
卡菲司米托
Carfilzomib
卡博替尼
Cabozantinib
考比替尼
卡比替尼
Cobimetinib
克唑替尼
Crizotinib
赛瑞替尼
色瑞替尼
塞瑞替尼
Ceritinib
达拉菲尼
Dabrafenib
达克替尼
Dacomitinib
Pfizer
达沙替尼
Dasatinib
康奈非尼
Encorafenib
艾达非替尼
erdafitinib
厄洛替尼
Erlotinib
特罗凯
罗氏
依维莫司
everolimus
呋喹替尼
Fruquintinib
吉非替尼
Gefitinib
易瑞沙
阿斯利康
伊布替尼
依鲁替尼
Ibrutinib
埃克替尼
Icotinib
凯美纳
浙江贝达
艾代拉里斯
idelalisib
维莫德
Vismodegib
中文通用药名

Gosogliptin (PF-00734200) 869490-23-3 GlpBio

Product Data SheetProduct Name:Gosogliptin (PF-00734200)Cat. No.:GC31463Chemical PropertiesCas No.869490-23-3ChemicalNameN/ACanonicalSMILESO=C([C@H](C1)NC[C@H]1N2CCN(CC2)C3=NC=CC=N3)N4CC(CC4)(F)FFormula C17H24F2N6O M.Wt366.41 Solubility Soluble in DMSO Storage Store at -20°CGeneral tips For obtaining a higher solubility , please warm the tube at 37 ℃ and shake it in the ultrasonic bath for a while.Stock solution can be stored below -20℃ for several months.Shipping Condition Evaluation sample solution : ship with blue ice All other available size: ship with RT , or blue ice upon request.StructureBackgroundGosogliptin is a potent and selective inhibitor of dipeptidyl peptidase-IV (DPP-IV).Product Data SheetGosogliptin (PF-00734200) is a potent, orally active, selective, and competitive inhibitor of DPP-IV, the enzyme mainly responsible for the degradation of the incretin peptides GLP-1 and glucose-dependent insulinotropic polypeptide. Gosogliptin demonstrates greater than 200-fold selectivity over other members of the DPP family (DPP-2, DPP-3, DPP-8, and DPP-9) and the related serine proteases, ﬁbroblast activation protein, aminopeptidase P, and propyl oligopeptidase, enzymes that possess similar catalytic activities. Gosogliptin demonstrates rapid and reversible inhibition of plasma DPP-4 activity when administered orally to rats, dogs, and monkeys. In various nonclinical models, Gosogliptin stimulates insulin secretion and improves glucose tolerance[2].The objectives of the present study are to characterize the metabolism, pharmacokinetics, and excretion of [14C] Gosogliptin in Sprague-Dawley (SD) rats, beagle dogs, and humans. A single dose of [14C] Gosogliptin is administered orally to intact SD rats (5 mg/kg), beagle dogs (5 mg/kg), and humans (20 mg). After a single oral dose of [14C] Gosogliptin to SD rats, an overall mean of 97.1% of the administered radioactivity is recovered in the urine, feces, and cage wash over a period of 168 h postdose. The mean cumulative dose recovered in feces is 66.0%. The mean cumulative excretion in the urine is 30.8%. Approximately 95% of the excreted radioactivity recovery occurred in the ﬁrst 48 h. Mean total recoveries of dosed radioactivity from bile duct-cannulated rats are 29.5% in urine and 62.0% in bile. No gender-related diﬀerences are observed in the excretion pattern of radioactivity[2].[1]. Dai H, et al. The pharmacokinetics of PF-734200, a DPP-IV inhibitor, in subjects with renal insuﬃciency. Br J Clin Pharmacol. 2011 Jul;72(1):85-91. [2]. Sharma R, et al. Metabolism, excretion, and pharmacokinetics of ((3,3-diﬂuoropyrrolidin-1-yl)((2S,4S)-4-(4-(pyrimidin-2-yl)piperazin-1-yl)pyrrolidin-2-yl)methanone, a dipeptidyl peptidase inhibitor, in rat, dog and human. Drug Metab Dispos. 2012 Nov;40(11):2143-61.。

利格列汀潜在杂质及基本信息

利格列汀杂质列表
利格列汀是由德国勃林格殷格翰公司与礼来公司联合开发的一种新型的抗糖尿病药物于 2011 年 5 月2 日被美国FDA 批准上市，2011 年8 月在欧盟获上市许可。

依据《药品注册管理办法》的有关规定，深圳卓越生物科技有限公司
全面提供利格列汀杂质。

利格列汀成为继西格列汀、沙格列汀、维格列汀和阿洛利汀之后又一个用于治疗 2 型糖尿病的二肽基肽酶-4（DPP-4）抑制剂。

基本信息
中文名称：利格列汀
英文名称：linagliptin
商品名：Tradjenta™
适应症：TRADJENTA 是一个二肽基肽酶-4（DPP-4）抑制剂，适用作为 2 型糖尿病成人中膳食和运动的辅助治疗改善血糖控制。

药品名称中英文词汇二

药品名称中英文词汇二药品名称中英文词汇二药品名称中英文词汇二达贝洛汀dabelotine达泊西汀dapoxetine达布米诺dalbraminol达伐他汀dalvastatin达非那新darifenacin达氟沙星danofloxacin达福普汀dalfopristin达肝素钠dalteparin sodium达格列酮darglitazone达加帕米dagapamil达卡巴嗪dacarbazine达考帕泛dacopafant达克罗宁dyclonine达库溴铵dacuronium bromide达来达林daledalin达仑西平darenzepine达罗地平darodipine达美格雷dazmegrel达美司特dametralast达莫替平damotepine达那肝素钠danaparoid sodium 达那唑danazol达尼喹酮daniquidone达诺司坦danosteine达帕布坦dapabutan达哌唑dapiprazole达匹坦dapitant达齐胺dazidamine达曲班daltroban达替氯铵datelliptium chloride 达托霉素daptomycin达西多明darsidomine达西马嗪dacemazine达西司坦dacisteine达昔单抗dacliximab达佐必利dazopride达佐霉素duazomycin达唑利辛dazolicine达唑司特dazoquinast达唑氧苯dazoxiben大风子酸乙酯ethyl chaulmoograte大观霉素spectinomycin大颗粒锝[99mtc]人血清白蛋白macrosalb[99mtc] 大颗粒碘[131i]人血清白蛋白macrosalb[131i]大麻酚cannabinol大麻克酯naboctate大麻隆nabilone大麻坦nabitan大麻折尼nabazenil丹蒽醌danthron；dantron丹皮酚paeonol丹曲林dantrolene单氯芬那酸monoclofenamic acid单硝酸异山梨酯isosorbide mononitrate胆茶碱oxtriphylline胆茶碱choline theophyllinate胆酸cholic acid胆影酸iodipamide胆影酸adipiodone胆影酸钠[131 i] adipiodone sodium[131 i]弹性酶elastase淡绿sf light green sf蛋氨酸methionine氮甲formylmerphalan氮芥chlormethine；mechlorethamine；mustine氮氯嗪azaclorzine氮尿苷floxuridine氮醛糖chloralose氮替瑞林azetirelin锝[99mtc]呋膦technetium[99mtc] furifosmin锝[99mtc]胶体硫technetium[99mtc] sulfur colloid 锝[99mtc]平妥单抗technetium(99mtc)pintumomab 德格列哚deriglidole德伦环烷deramciclane德帕烟酯derpanicate登布茶碱denbufylline登齐醇denzimol登溴克新dembroxol登溴克新dembrexine低精蛋白胰岛素isophane insulin滴滴涕chlorophenothane；clofenotane；dicophane 镝双胺sprodiamide狄氏剂dieldrin敌敌畏dichlorvos敌噁磷dioxathion；dioxation 敌匹硫磷diazinon；dimpylate 地吖醌diaziquone地阿巴隆diarbarone地阿诺deanol地奥氨酯dioxamate地奥地洛dioxadilol地奥沙屈dioxadrol地奥司明diosmin地巴唑dibazol地巴唑bendazol地百里砜diathymosulfone地贝卡星dibekacin地吡溴铵dimetipirium bromide 地丙苯酮diprafenone地丙沙朵diproxadol地波沙美deboxamet地泊溴铵dipenine bromide地泊溴铵diponium bromide地布匹隆dibupyrone地布沙朵dibusadol地布酸钠sodium dibunate地布酸乙酯ethyl dibunate地恩丙胺diampromide地蒽酚anthralin地蒽酚dithranol地尔美封dilmefone地发哌嗪delfaprazine地伐帕米devapamil地伐普隆divaplon地伐特罗divabuterol地伐西匹devazepide地法胰岛素insulin defalan地芬南diphenan地芬尼多difenidol；diphenidol地芬尼泰diamfenetide；diamphenethide 地芬诺辛difenoxin地芬诺酯diphenoxylate地夫可特deflazacort地弗他酮diftalone地氟烷desflurane地福沙肼diphoxazide地高辛digoxin地海哌酮dihyprylone地红霉素dirithromycin地卡芬dicarfen地考喹酯decoquinate地考米醇decominol地克珠利diclazuril地库碘铵dicolinium iodide地喹氯铵dequalinium chloride 地拉普利delapril地拉韦啶delavirdine地来夸明delequamine地来洛尔dilevalol地来西坦dimiracetam地林哌隆declenperone地磷酰胺defosfamide地仑雄酮delanterone地洛瑞林deslorelin地洛索龙deloxolone地洛西泮delorazepam地马待克丁dimasdectin地马孕酮delmadinone地马唑diamthazole；dimazole 地麦角腈delergotrile地美丙蒽dimeprozan地美庚醇dimepheptanol；methadol 地美环素demethylchlortetracycline 地美环素demeclocycline地美罗酸dimecrotic acid地美尼诺desmeninol地美炔酮dimethisterone地美沙朵dimenoxadol地美司钠dimesna地美索酯dimethoxanate地美替林demexiptiline地美维林demelverine地美戊胺dimevamide地美硝唑dimetridazole地美辛delmetacin地美溴铵demecarium bromide地美孕酮demegestone地孟汀dimantine；dymanthine地莫单抗detumomab地莫康唑democonazole地莫匹醇decapinol；delmopinol地莫前列素dimoxaprost地莫西泮demoxepam地莫昔林dimoxyline地那林dinaline地那维林denaverine地那扎封dinazafone地奈德desonide；hydroxyprednisolone acetonide 地尼必利denipride地尼茶碱diniprofylline地诺帕明denopamine地诺前列素dinoprost；prostaglandin f2a地诺前列酮dinoprostone；prostaglandin e2地诺孕素dienogest地帕明depramine地哌冬diperodon地匹福林dipivefrine地匹哌酮dipipanone地匹乙酯dipyrocetyl地泼罗酮deprodone地普喹酮diproqualone地普罗芬diprofene地普托品deptropine地前列素deprostil地前列酯delprostenate地秦胺dezinamide地屈孕酮dydrogesterone地瑞舒林dicresulene地塞米松dexamethasone地沙匹定desaspidin地沙双酮diethadione地舍平deserpidine地舒勒近disulergine地司维林dexsecoverine地素吗啡desomorphine地索苯宁disofenin地索布胺disobutamide地索苷disogluside地索普明diisopromine；disopromine 地索隐亭desocriptine地他诺柳detanosal地他唑ditazole地肽瑞里detirelix地特氯铵ditercalinium chloride地特诺deterenol地托胺ditolamide地托比星detorubicin地托咪定detomidine地托酞ditophal地戊曲酯didrovaltrate地西拉嗪dixyrazine地西利酮dicirenone地西龙descinolone地西卢定desirudin地西氯铵disiquonium chloride地西洛可龙locicortolone dicibate；locicortone 地西泮diazepam地西他滨decitabine地西铁diciferron地西托品decitropine地西唑林dexetozoline地昔卡因dexivacaine地昔洛韦desciclovir地昔帕明desipramine地扎胍宁dezaguanine地扎曲酮dizatrifone地佐环平dizocilpine地佐辛dezocine睇波芬stibophen睇沙胺stibosamine碘[123ⅰ]必利iolopride碘[123ⅰ]氟潘ioflupane(123ⅰ)碘[123i]非他胺iofetamine[123i]碘[123i]西尼iomazenil[123i]碘[125i]化钠sodium iodide[125i]碘[125i]马尿酸钠sodium iodohippurate[125i]碘[125i]美丁iometin[125i]碘[125i]人血清白蛋白iodinated human serum albumin [125i]碘[125i]塞罗宁liothyronine[125i]碘[125i]他拉酸钠sodium iotalamate[125i]碘[125i]纤维蛋白原fibrinogen[125i]碘[131i]胆甾醇iodocholesterol[131i]碘[131i]化钠sodium iodide[131i]碘[131i]马尿酸钠sodium iodohippurate[131i]碘[131i]美丁iometin[131i]碘[131i]人血清白蛋白iodinated human serum albumin [131i]碘[131i]塞罗宁liothyronine[131i]碘[131i]他拉酸钠sodium iotalamate[131i]碘[131i]托泊酮tolpovidone[131i]碘阿芬酸iodoalphionic acid；pheniodol碘奥酮iodopyracet碘奥酮diodone碘苯扎酸iobenzamic acid碘苯酯iophendylate碘苯酯iofendylate碘比醇iobitridol碘吡多iopydol碘吡酮iopydone碘苄胍iobenguane碘丙甘油iodopropylidene glycerol碘泊酸iopodic acid碘泊酸钙calcium iopodate碘泊酸钠ipodate sodium；sodium iopodate 碘达胺iodamide碘多啥iodoxyl；sodium iodomethamate碘二噻宁dithiazanine iodide碘番酸iopanoic acid碘泛影丙酯propyl docetrizoate碘仿iodoform碘芬布酸phenobutiodil碘芬酸iophenoic acid；iophenoxic acid 碘佛醇ioversol碘甘卡酸ioglycamic acid碘肝素钠iodoheparin sodium碘苷idoxuridine碘格利酸ioglicic acid碘桂酸钠cinamiodil sodium碘海醇iohexol碘化钾potassium iodide碘化油iodinated oil；iodized oil碘磺拉胺iosulamide碘甲胆碱methylcholine iodide碘甲磺钠methiodal sodium；metiodol 碘解磷定pralidoxime iodide碘卡酸iocarmic acid碘卡乙酯ethyl cartrizoate碘克沙醇iodixanol碘克沙酸ioxaglic acid碘克溴酸ioxabrolic acid碘拉醇iofratol碘硫氧嘧啶iodothiouracil碘马尿酸iodohippuric acid碘吗酸iomorinic acid碘没食子酸铋bismuth oxyiodogallate 碘美拉酸iomeglamic acid碘美普尔iomeprol碘帕醇iopamidol碘喷托iopentol碘葡胺ioglucomide碘葡苯胺ioglunide碘葡醇ioglucol碘普胺iopromide碘普罗酸iopronic acid碘普西酸ioprocemic acid碘羟拉酸ioxitalamic acid碘曲仑iotrolan碘曲西酸iotroxic acid碘去氧胞苷iododeoxycytidine碘软脂酸iodocetylic acid碘塞罗宁liothyronine碘赛特iotriside碘沙考iosarcol碘沙酸iodoxamic acid碘丝酸ioseric acid碘酸钾potassium iodate碘他拉酸iotalamic acid；iothalamic acid碘酞硫iotasul碘酞钠iodophthalein sodium碘替酸iotetric acid碘西胺iosimide碘西醇iodecimol碘西法酸iosefamic acid碘西他酸iocetamic acid碘昔兰ioxilan碘依可酯ecostigmine；ecothiopate iodide碘硬酯iodetryl淀粉starch淀粉硫酸钠sodium amylosulfate淀粉酶diastase淀粉酶抑肽tendamistat靛胭脂indigo carmine；indigotindisulfonate sodium 靛玉红indirubin叠氮氯霉素azidamfenicol蝶罗呤pteropterin丁吖卡因bucricaine丁胺卡因butethamine丁巴比妥butobarbital；butobarbitone丁苯碘胺bufeniode丁苯柳胺butylphenamide丁苯那胺bufenadrine丁苯那嗪tetrabenazine丁苯宁butilfenin丁苯羟酸bufexamac丁苯唑酸bufezolac丁吡考胺bupicomide丁丙诺啡buprenorphine丁碘桂酸bunamiodyl；buniodyl丁二酸succinic acid丁非洛尔butofilolol丁夫罗林bufrolin丁呋洛尔bufuralol丁福明buformin丁卡因amethocaine；tetracaine丁喹伦buquineran丁喹酯buquinolate丁硫妥钠buthalitone sodium；thialbutone sodium 丁硫妥钠buthalital sodium丁咯地尔buflomedil丁氯柳胺buclosamide丁螺环酮buspirone丁萘夫汀bunaftine丁萘脒bunamidine丁尼辛butanixin丁羟茴醚butylated hydroxyanisole丁羟甲苯butylated hydroxytoluene丁氰酯bucrilate丁四硝酯erythrityl tetranitrate丁酮肟diacetylmonoxime丁烯比妥crotarbital丁烯烟肼crotoniazide丁香酚eugenol丁溴比妥butallylonal丁溴东莨菪碱hyoscine butylbromide；scopolamine butylbromide定磺胺dinsed东莨菪碱hyoscine；scopolamine东莨菪亭scopoletin豆甾醇stigmasterol毒扁豆碱physostigmine毒毛花苷g ouabain；strophanthin g 毒毛花苷k strophanthin k杜鹃素farrerol度奥哌隆duoperone度氟西泮doxefazepam度拉西坦dupracetam度琉平dothiepin度琉平dosulepin度氯扎封dulozafone度洛贝特dulofibrate度洛西汀duloxetine度麦角胺dosergoside度美辛duometacin度米芬domiphen bromide度莫瑞林dumorelin度替普酶duteplase度维a doretinel短杆菌素tyrothricin短杆菌肽gramicidin短杆菌肽s gramicidin s对氨马尿酸钠sodium aminohippurate对氨水杨酸aminosalicylic acid对氨水杨酸钠sodium aminosalicylate对丙胺酚parapropamol对氟噻嗪paraflutizide对甲氧酚mequinol对氯苯丁胺chlorphentermine对氯酚parachlorophenol对羟苯丙酮paroxypropione对伞花烃paracymene对硝苯磷酯paraoxone对乙酰氨基酚acetaminophen；paracetamol 对乙氧卡因parethoxycaine多巴胺dopamine多巴酚丁胺dobutamine多巴金刚dopamantine多倍他索doxibetasol多布必利dobupride多地辛dodicin多地溴铵dodeclonium bromide多法氯铵dofamium chloride多非利特dofetilide多卡巴胺docarpamine多卡氯铵dodecarbonium chloride多康唑doconazole多库氯铵doxacurium chloride多库酯钠dioctyl sodium sulfosuccinate；docusate sodium 多夸司特doqualast多拉克汀doramectin多拉司琼dolasetron多拉斯汀dorastine多拉西坦doliracetam多硫酸木聚糖xylan polysulfuric acid多马唑啉domazoline多米奥醇domiodol多米匹宗domipizone多米曲班domitroban多奈哌齐donepezil多奈替丁donetidine多潘chlorethylaminouracil多潘dopan多潘立酮domperidone多培沙明dopexamine多匹可明doxpicomine多泼尼酯domoprednate多普吡地dopropidil多柔比星adriamycin 多柔比星doxorubicin 多瑞肽doreptide多塞平doxepin多沙米诺doxaminol多沙普仑doxapram多沙前列素doxaprost 多沙唑嗪doxazosin多司马酯dosmalfate 多索茶碱doxofylline 多他利嗪dotarizine多糖铁polyferose多西苯醌docebenone 多西环素doxycycline 多西拉敏doxylamine 多西他赛docetaxel多依雌酸doisynoestrol 多粘环素colimecycline 多粘菌素b polymyxin b 多粘菌素e polymyxin e 多粘菌素e colistin多粘菌素e甲磺酸钠colistimethate sodium；colistin sulphomethate多佐胺dorzolamide莪术醇curcumenol鹅去氧胆酸chenodiol鹅去氧胆酸chenodeoxycholic acid厄贝沙坦irbesartan厄布洛唑erbulozole厄多司坦erdosteine厄索夫明ersofermin恩吡哌唑enpiprazole恩丙茶碱enprofylline恩丙西平enprazepine恩波吡维铵pyrvinium embonate；pyrvinium pamoate；viprynium embonate恩波副品红pararosaniline embonate恩波环氯胍cycloguanil embonate恩布拉敏embramine恩布沙坦embusartan恩布酯enbucrilate恩地氯铵碘undecoylium chloride iodine恩多霉素endomycin恩多米特endomide恩氟沙星enrofloxacin恩氟烷enflurane恩格列酮englitazone恩环丙酯encyprate恩甲羟松endrisone；endrysone恩卡尼encainide恩康唑enilconazole恩拉毒素enramycin恩氯米芬cisclomifene；enclomifene 恩洛铂enloplatin恩莫单抗enlimomab恩尼贝特eniclobrate恩哌罗林enpiroline恩普氨酯enpromate恩前列素enprostil恩屈嗪endralazine恩他卡朋entacapone恩韦*** enviradene恩韦肟enviroxime恩维霉素enviomycin恩西拉嗪enciprazine二氨藜芦啶diaveridine二胺卡因diamocaine二苯拉林diphenylpyraline二苯马尼diphenmethanil二苯马尼diphemanil二苯美伦bifemelane二苯米唑difenamizole二苯帕诺diphepanol二苯沙秦difencloxazine二苯特罗difeterol二苯托品diphenyltropine二苯西平dibenzepin二苯茚酮diphacinone；diphenadione 二苯唑啉diphenazoline二丙丁胺diprobutine二丙泛影钠sodium diprotrizoate二丙诺啡diprenorphine二丙维林diproteverine二丙戊酰胺valdipromide二丙竹桃霉素diproleandomycin二醋洛尔diacetolol二醋吗啡heroin二醋吗啡diamorphine二醋纳洛啡diacetylnalorphine二醋水杨酸diacesalyl二醋酸茚雌酚indenoestrol diacetate 二氮嗪diazoxide二碘甲磺钠dimethiodal sodium二碘硝酚disophenol二噁沙利disoxaril二氟可龙diflucortolone二氟拉松diflorasone二氟米酮diflumidone二氟那嗪difluanazine二氟尼柳diflunisal二氟泼尼酯difluprednate二氟沙星difloxacin二环霉素bicozamycin二黄原酸dixanthogen二磺法胺disulphamide二磺法胺disulfamide二甲氨丙醇dimepranol二甲胺嗪ampyzine二甲苯xylene二甲雌酚dimethoxydiethylstilbene二甲法登dimefadane二甲非他明dimetamfetamine二甲啡烷dimemorfan二甲弗林dimefline二甲福林dimetofrine二甲硅油dimethicone；dimeticone；polysilane二甲卡因dimethocaine二甲拉嗪dimelazine二甲力嗪dimetholizine二甲噻丁dimethylthiambutene二甲沙生dimethazan二甲双胍metformin二甲双酮dimethadione二甲他林dimetacrine二甲替嗪dimethothiazine；dimetiotazine；dimetotiazine；fonazine二甲亚砜dimethyl sulfoxide二甲茚定dimethindene；dimetindene二链烟肼distreptoniazid二硫化硒selenium sulfide二硫卡钠ditiocarb sodium二硫拉唑disuprazole二硫莫司汀ditiomustine二氯胺dichloramine二氯贝特biclofibrate二氯苯甲醇dichlorbenzyl alcohol二氯苯胂dichlorophenarsine二氯苄氯铵dichlorbenzalkonium chloride二氯地尔biclodil二氯二甲酚dichloroxylenol二氯呋利diclofurime二氯美泰diclometide二氯尼特diloxanide二氯尼辛diclonixin二氯嗪酮dichlormezanone二氯松dichlorisone二脒那秦diminazene二羟苯宗dioxybenzone二羟丙茶碱diprophylline二羟非君dioxifedrine二羟西君dioxethedrin二氢埃托啡dihydroetorphine二氢维生素k1磷酸钠phytonadiol sodium diphosphate二巯丙醇dimercaprol二巯丙磺钠sodium dimercaptopropanesulfonate 二巯丁二钠sodium dimercaptosuccinate二巯丁二酸succimer二十二碳六烯酸doconexent二十碳五烯酸icosapent二硝托胺dinitolmide二溴甘露醇mitobronitol二溴酪氨酸dibromotyrosine二溴螺氯铵dibrospidium chloride二溴沙仑dibromsalan二溴卫矛醇mitolactol二氧丙嗪dioxopromethazine二氧化硅silicon dioxide二氧化钛titanium dioxide二氧化碳carbon dioxide二乙丙二醇diethylpropanediol二乙甲苯酚胺diethyltoluamide二乙嗪diethazine二乙噻丁diethylthiambutene二乙烯丙醋胺diethylallylacetamide二异丙胺diisopropylamine伐多卡因vadocaine伐米胺vamicamide伐奈莫林valnemulin伐奈普林vaneprim伐诺司林vanoxerine伐哌前列素vapiprost伐普肽vapreotide伐昔洛韦valaciclovir法贝司琼fabesetron法倔唑fadrozole法利帕米falipamil法林洛尔falintolol法罗培南faropenem法米氯铵famiraprinium chloride 法莫替丁famotidine法莫汀famotine法奈替唑fanetizole法南色林fananserin法舒地尔fasudil法西多曲法西多曲fasidotril法西普隆fasiplon法扎拉滨fazarabine法扎溴铵fazadinium bromide凡士林vaseline反苯环丙胺tranylcypromine泛醇panthenol泛癸利酮coenzyme q10；ubidecarenone泛喹酮phanquinone；phanquone泛硫乙胺pantethine泛尼酯pantenicate泛普法宗famprofazone泛曲酮fanthridone泛曲酮fantridone泛酸钙calcium pantothenate泛托法隆fantofarone泛昔洛韦famciclovir泛影酸diatrizoic acid泛影酸amidotrizoic acid泛影酸钠sodium amidotrizoate；sodium diatrizoate 泛影酸钠[125i] sodium amidotrizoate[125i]泛影酸钠[131i] sodium amidotrizoate[131i]放线菌素c actinomycin c放线菌素c cactinomycin放线菌素d dactinomycin 非阿尿苷fialuridine非巴氨酯febarbamate非班太尔febantel非吡三唑fepitrizol非布丙醇febuprol非布维林febuverine非布西林fibracillin非多托秦fedotozine非尔氨酯felbamate非格司亭filgrastim非克立明feclemine非来那朵filenadol非律平filipin非洛地平felodipine非明司特filaminast非莫西汀femoxetine非那吡啶phenazopyridine 非那丙胺phenampromide 非那二醇phenaglycodol 非那夫酸fenaftic acid非那卡因phenacaine非那可隆fenaclon非那可明fenalcomine非那拉胺fenalamide非那米柳fenamisal非那莫fenamole非那哌隆fenaperone非那西丁acetophenetidin；phenacetin 非那雄胺finasteride非那佐辛phenazocine非那唑啉phenamazoline非奈西林phenethicillin；pheneticillin 非尼贝特fenirofibrate非尼啶醇fenyripol非尼拉朵fenyramidol；phenyramidol 非尼拉敏pheniramine非尼雷司fenisorex非尼米特fenimide非尼戊醇fenipentol非诺班fenobam非诺贝酸fenofibric acid非诺贝特fenofibrate非诺吡酮phenopyrazone非诺地尔fenoxedil非诺多泮fenoldopam非诺啡烷phenomorphan 非诺洛芬fenoprofen非诺特罗fenoterol非诺维林fenoverine非诺西醇fenocinol非诺唑啉fenoxazoline 非诺唑酮fenozolone非哌西特fipexide非普地醇fepradinol非普拉宗feprazone非屈酯fedrilate非沙比妥phetharbital非索非那定fexofenadine 非托西酯fetoxylate非托西酯fetoxilate非西他滨fiacitabine非昔硝唑fexinidazole非扎硫酮fezatione非唑拉明fezolamine吩塞秦phenothiazine芬胺呋fenamifuril芬贝西林fenbenicillin；phenbenicillin 芬苯达唑fenbendazole芬苯扎胺phenbezamine芬布芬fenbufen芬布酯fenbutrazate；phenbutrazate 芬雌酸fenestrel芬地林fendiline芬度柳fendosal芬氟拉明phenfluoramine芬氟拉明fenfluramine芬氟咪唑fenflumizole芬氟司林fenfluthrin芬格鲁胺phenglutarimide芬哈孟fenharmane芬咖明fencamine芬卡米特fencarbamide芬坎法明fencamfamin芬克洛宁fenclonine芬克洛酸fenclozic acid芬喹唑fenquizone芬留顿fenleuton芬氯磷fenchlorfos；fenclofos芬氯酸fenclofenac芬美曲秦oxazimedrine；phenmetrazine 芬哌丙烷fenpiprane芬哌酰胺fenpipramide芬普雷司fenproporex芬前列林fenprostalene芬曲地尔fenetradil芬司匹利fenspiride芬太尼fentanyl芬特明phentermine芬替康唑fenticonazole芬替克洛fenticlor芬替酸fentiazac芬托氯铵phenactropinium chloride芬托溴铵fentonium bromide芬维a胺fenretinide芬戊二醇fenpentadiol芬西布醇fencibutirol芬乙茶碱fenethylline芬乙茶碱fenetylline芬乙嗪fenethazine酚苄明bensylyt；phenoxybenzamine酚丁oxyphenisatin酚二唑phenadiazole酚二唑fenadiazole酚磺酞phenol red；phenolsulfonphthalein 酚磺乙胺etamsylate酚加宾fengabine酚酞phenolphthalein酚妥拉明phentolamine粉防己碱tetrandrine粉肌松tetrandrine dimethiodide奋乃静perphenazine风疹疫苗rubella vaccine夫拉美诺flamenol夫拉扎勃furazabol夫拉扎酮flazalone夫雷非班fradafiban夫仑替唑frentizole夫罗吡地fronepidil夫洛丙酮flopropione夫洛地尔floredil夫洛非宁floctafenine夫洛梯隆florantyrone夫马洁林fumngillin夫诺维林floverine夫沙芬净fusafungine夫替瑞林fertirelin夫西地酸fusidic acid夫西地酸钠sodium fusidate 呋氨蝶啶furterene呋波碘铵fubrogonium iodide 呋布西林furbucillin呋碘达隆furidarone呋芬雷司furfenorex呋格雷酸furegrelate呋甲噁酮furmethoxadone呋拉茶碱furafylline呋拉迪克丁fuladectin呋拉尼酸furacrinic acid呋罗布芬furobufen呋罗雌酚furostilbestrol呋罗达唑furodazole呋罗芬酸furofenac呋洛芬furcloprofen呋洛西林fuzlocillin呋莫西林fumoxicillin呋喃丙胺furapromide呋喃拉嗪nifuralazine呋喃拉嗪furalazine呋喃硫胺fursutiamine呋喃洛芬furaprofen呋喃他酮furaltadone呋喃妥因nitrofurantoin呋喃西林nitrofural；nitrofurazone 呋喃唑酮nifurazolidone呋喃唑酮furazolidone呋尼地平furnidipine呋普拉唑fuprazole呋曲安奈德triamcinolone furetonide 呋塞米frusemide；furosemide呋沙仑fursalan呋索碘铵furtrethonium iodide呋替啶furethidine呋烟腙furilazone呋唑氯铵furazolium chloride伏高利特voxergolide伏格列波糖voglibose伏拉佐辛volazocine伏立康唑vorionazole伏氯唑vorozole伏妥莫单抗votumumab氟[18f]多巴fluorodopa[18f]氟[18f]脱氧葡糖fludeoxyglucose 氟阿尼酮fluanisone氟氨雷司fluminorex氟巴尼酯flubanilate氟班色林flibaserin氟胞嘧啶flucytosine氟贝必利flubepride氟苯达唑flubendazole氟苯柳flufenisal氟苯尼考florfenicol氟苯乙砜fluoresone氟比洛芬flurbiprofen氟丙茶碱fluprofylline氟丙喹宗fluproquazone氟达拉滨fludarabine氟氘丙氨酸fludalanine氟地西泮fludiazepam氟丁特罗flerobuterol氟多雷司fludorex氟朵林fluradoline氟伐他汀fluvastatin氟法胺flurofamide氟非宁florifenine氟芬那酸flufenamic acid氟奋乃静flufenazine；fluphenazine 氟伏沙明fluvoxamine氟骨三醇falecalcitriol氟桂利嗪flunarizine氟红霉素flurithromycin氟化钠sodium fluoride氟甲氮平flumezapine氟甲睾酮fluoxymesterone氟甲喹flumequine氟甲噻嗪flumethiazide氟甲沙朵flumexadol氟卡布利flucarbril氟卡尼flecainide氟可丁fluocortin氟可龙fluocortolone氟克吖啶floxacrine氟克立酯flucrilate氟喹酮afloqualone氟喹宗fluquazone氟拉胺flualamide氟拉洛芬frabuprofen氟磷柳flufosal氟鲁茶碱flufylline氟氯奈德flucloronide氟氯奈德fluclorolone acetonide 氟氯西林floxacillin氟氯西林flucloxacillin氟仑太尔flurantel氟罗沙星fleroxacin氟洛芬fluprofen氟洛克生fluparoxan氟马西尼flumazenil氟美立酮flumeridone氟美吗酮flumetramide氟美西诺flumecinol氟美烯酮flumedroxone氟米龙fluorometholone氟米松flumetasone氟莫奈德flumoxonide氟尼缩松flunisolide氟尼辛flunixin氟尿嘧啶fluoracil；fluorouracil；fluracil 氟诺洛芬flunoxaprofen氟诺前列素flunoprost氟哌醇胺fluperamide氟哌啶醇haloperidol氟哌利多droperidol氟哌噻吨flupentixol氟培拉平fluperlapine氟培龙fluperolone氟泼尼定fluprednidene氟泼尼龙fluprednisolone氟普拉嗪fluprazine氟齐胺fluzinamide氟前列醇fluprostenol氟氢可的松fludrocortisone氟氢缩松fludroxycortide；flurandrenolide；flurandrenolone氟轻松fluocinolone acetonide氟曲林flutroline氟曲马唑flutrimazole氟曲尼嗪flotrenizine氟曲辛fluotracen氟瑞托芬fluretofen氟沙地尔flosatidil氟沙仑fluorosalan氟沙仑flusalan氟舒胺flosulide氟司必林fluspirilene氟司喹南flosequinan氟司洛尔flestolol氟司哌隆fluspiperone氟索洛尔flusoxolol氟他胺flutamide氟他唑仑flutazolam氟替阿嗪flutiazin氟替尔flurothyl；flurotyl氟替卡松fluticasone氟托咪酯flutomidate氟托西泮flutoprazepam氟托溴铵flutropium bromide氟烷halothane氟西雷司flucetorex氟西泮flurazepam氟西他滨flurocitabine氟西汀fluoxetine氟西吲哚flucindole氟硝西泮flunitrazepam氟硝唑flunidazole氟辛克生flesinoxan氟氧喷fludoxopone氟氧前列素froxiprost氟氧头孢flomoxef氟乙西泮fletazepam氟乙烯醚fluroxene氟茚二酮fluindione氟茚香豆素fluindarol氟孕酮flugestone；flurogestone 氟扎可特fluazacort氟佐隆fluazuron氟唑培啉fluzoperine福地吡fodipir福尔可定pholcodine福酚美克forfenimex福拉沙坦forasartan福来君pholedrine福罗帕泛foropafant福美雷司formetorex福美坦formestane福米诺苯fominoben福米韦生fomivirsen福米西林fomidacillin；formidacillin 福米硝唑forminitrazole福莫卡因fomocaine福莫可他formocortal福莫司汀fotemustine福莫特罗formoterol福齐夫定替酯fozivudine tidoxil福曲他明fotretamine福司吡酯fospirate福司地尔fostedil福司肼fosenazide福司曲星fostriecin福辛普利fosinopril福辛普利拉fosinoprilat脯氨酸proline辅酶i nadide辅羧酶cocarboxylase副醛paraldehyde富马酸亚铁ferrous fumarate钆贝酸gadobenic acid钆布醇gadobutrol钆弗塞胺gadoversetamide钆喷胺gadopenamide钆喷酸gadopentetic acid钆塞酸gadoxetic acid钆双胺gadodiamide钆特醇gadoteridol钆特酸gadoteric acid钙立醇calteridol干扰素interferon甘氨茶碱钠theophylline sodium glycinate 甘氨酸aminoacetic acid；glycine甘氨酸镁铝magnesium aluminium glycinate甘铋胂glycobiarsol甘草次酸glycyrrhetinic acid甘草次酸enoxolone甘磷酸胆碱choline glycerophosphate甘磷酸胆碱choline alfoscerate甘磷酰芥glyfosfin甘露醇mannitol甘露六硝酯mannitol hexanitrate；mannityl nitrate 甘露莫司汀mannomustine甘露舒凡mannosulfan甘珀酸carbenoxolone甘羟铝dihydroxyaluminium aminoacetate甘胂米特glycarsamide甘油glycerin；glycerol甘油磷酸钠sodium glycerophosphate杆菌肽bacitracin肝素heparin橄榄霉素olivomycin刚果红congo red高锝[99mtc]酸钠sodium pertechnetate[99mtc]高泛酸hopantenic acid高氟奋乃静homofenazine高氯环秦homochlorcyclizine高氯酸硝胆碱nitricholine perchorate 高锰酸钾potassium permanganate 高三尖杉酯碱homoharringtonine高血糖素glucagon高烟酸homonicotinic acid睾内酪testolactone睾酮testosterone戈拉碘铵gallamine triethiodide戈雷拉肽goralatide戈洛帕米gallopamil戈那瑞林gonadorelin戈舍瑞林goserelin格拉非宁glafenine格拉莫德glaspimob格拉齐文glaziovine格拉司琼granisetron格来色林glemanserin格劳卡昔glaucarubin格列胺脲gliamilide格列本脲glibenclamide；glyburide 格列吡脲glyclopyramide格列吡嗪glipizide格列丙唑glyprothiazole格列波脲glibornuride格列布唑glysobuzole；isobuzole格列达脲glidazamide格列丁胺glibutimine格列丁唑desaglybuzole；glybuzole格列氟胺gliflumide格列环脲glycyclamide格列己脲glyhexamide格列卡胺glicaramide格列康胺glicondamide格列喹酮gliquidone格列美脲glimepiride格列嘧啶钠glidiazine；glymidine sodium 格列帕脲glyparamide格列派特glisoxepide格列平脲glypinamide格列齐特gliclazide格列噻唑glybuthiazole格列沙脲glisamuride格列生脲glisentide。

Sitagliptin (phosphate)_DPP-4抑制剂_654671-78-0_Apexbio

产品说明书
化学性质
产品名: Sitagliptin (phosphate) 修订日期: 6/30/2016
产品名: Cas No.: 分子量: 分子式: 别名: 化学名:
般建议:
运输条件:
Sitagliptin (phosphate)
654671-78-0
505.3
FC1=CC(C[C@H](CC(N2CC3=NN=C(N3CC2)C(F)(F)F)=O)N)=C(C=C1F)F. O=P(OO)=O.[HH]
>24.4mg/mL in DMSO
Store at -20°C
For obtaining a higher solubility , please warm the tube at 37°C and shake it in the ultrasonic bath for a while.Stock solution can be stored below -20°C for several months.
参考文献: [1] Biftu T, Feng D, Qian X, et al. (3R)-4-[(3R)-3-Amino-4-(2, 4, 5-trifluorophenyl) butanoyl]-3-(2, 2, 2-trifluoroethyl)-1, 4-diazepan-2-one, a selective dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes[J]. Bioorganic & medicinal chemistry letters, 2007, 17(1): 49-52. [2] Fleischer B. CD26: a surface protease involved in T-cell activation[J]. Immunology today, 1994, 15(4): 180-184. [3] Aschner P, Kipnes M S, Lunceford J K, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes[J]. Diabetes care, 2006, 29(12): 2632-2637. [4] Green J B, Bethel M A, Armstrong P W, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes[J]. New England Journal of Medicine, 2015, 373(3): 232-242.

Saxagliptin_BMS-477118_DPP-4_CAS号361442-04-8说明书_AbMole中国

分子量315.41溶解性（25°C）DMSO 63 mg/mL分子式C H N O Water 63 mg/mLCAS号361442-04-8Ethanol 24 mg/mL储存条件3年 -20°C 粉末状生物活性Saxagliptin (Onglyza) is a new dipeptidyl peptidase-4 (DPP-4) inhibitor with IC50 of 50 nM. BI 1356 inhibited DPP-4 activity in vitro with an IC (50) of approximately 1 nM, compared with sitagliptin (19 nM), alogliptin (24 nM), saxagliptin (50 nM), and vildagliptin (62 nM). BI 1356 was a competitive inhibitor, with a K (i) of 1 nM.实验操作来自于公开的文献，仅供参考细胞实验细胞系方法浓度处理时间动物实验动物模型Male 13−14 week-old ob/ob mice配制Water剂量10 μmol/kg给药处理Orally不同实验动物依据体表面积的等效剂量转换表（数据来源于FDA指南）小鼠大鼠兔豚鼠仓鼠狗重量 (kg)0.020.15 1.80.40.0810体表面积 (m)0.0070.0250.150.050.020.5K系数36128520动物 A (mg/kg) = 动物 B (mg/kg) ×动物 B的K系数动物 A的K系数例如，依据体表面积折算法，将白藜芦醇用于小鼠的剂量22.4 mg/kg 换算成大鼠的剂量，需要将22.4 mg/kg 乘以小鼠的K系数（3），再除以大鼠的K系数（6），得到白藜芦醇用于大鼠的等效剂量为11.2 mg/kg。

蛋白操作相关试剂

AP 和HRP 印迹显色底物
底物适用于Western .斑点印迹显色，满足显色所需要的灵敏和低背景。经检测与Novagen所提供的相关检测试剂盒配合使用，具良好重现性。
AP 检测试剂包括BCIP和NBT 标准溶液，提供20ⅹAP 缓冲液，用于AP偶联物的高灵敏度生色检测。采NBT/BCIP 系统，阳性条带会产生深蓝紫色条带，不易褪色。
PopCulture 试剂以即用型Tris—缓冲试剂形式提供，室温条件下很稳定。
特点
不用从培养基中别离细胞
不用机械方法破坏细胞
纯化前不需要对细胞粗提物进展处理
直接从培养体系粗提物中亲和纯化目的蛋白
在一个培养管或孔中完成所有的细胞培养和纯化操作
PopCulture 纯化试剂盒
PopCulture试剂也和His?Mag或GST?Mag琼脂糖珠和相应的缓冲试剂组成试剂盒一起提供，也有加上rLysozyme溶液的试剂盒，采用磁化别离，使抽提和亲和纯化更加方便。这些试剂盒足够用于40ⅹ3ml培养物纯化，依琼脂糖珠结合能力不同，3ml培养物的融合蛋白产量达His?Tag?375ug或GST?Tag?150ug。
PopCulture 试剂
PopCulture试剂是一种浓缩去污剂配方试剂，可以不需要离心收集细胞，直接参加E-coli培养物并高效抽提蛋白。重组蛋白在粗提物中即可分析，也可以参加亲和树脂，洗基质—目的蛋白复合物以去除培养基和细胞残片，接着从基质上交纯化的蛋白洗提下来。整个培养，抽提和纯化步骤都可以在原来的培养管或多孔板里进展。这种直接在培养基体系中进展蛋白检测和纯化操作特别适合蛋白组学研究和其它高通量操作要求，它使整个过程变得省时而方便。用这种方法，用His?Bind?和GST?Bind? 树脂〔1，2〕纯化培养物，已经获得了非常完整的融合蛋白。采用His?Mag?或GST?Mag?磁化琼脂糖珠注可以实现全部操作在一个管里进展，而且也不需要纯化柱和离心(3).参加rLysozyme?溶液或采用pLysS宿主菌有助于提高本方法抽提蛋白的效率。也可以考虑参加Benzonase?核酸酶以降低抽提物的粘度。

罗氟司特杂质列表及基本信息

罗氟司特杂质列表及基本信息
1243391-44-7
2010 年 7 月，欧盟批准 Nycomed 公司的罗氟司特(roflumilast，Daxas)上市, 用于慢性阻塞性肺疾病(COPD)的治疗。

罗氟司特是十多年来首次获得欧盟批准的
新一类COPD 治疗药物。

2011 年3 月 1 日，FDA 批准罗氟司特用于治疗COPD。

深圳卓越生物科技有限公司全面提供罗氟司特标准品，罗氟司特杂质对照品。

基本信息
商品名：Daxas
中文名：罗氟司特
英文名：Roflumilast
CAS 号：162401-32-3
适应症：用于慢性阻塞性肺炎( COPD) 的治疗
专利情况：罗氟司特在中国有化合物专利“氟烷氧基取代的苯甲酰胺类及其制备方法和应用” (WO09501338、CN94192659),该专利于 1994 年7 月2 日申请，1999 年 12 月1 日授权，保护了该化合物、制备方法以及在治疗气道疾病或皮肤病的应用。

该专利将于 2014 年 7 月 2 日到期。

SIMCOR说明书(美国,原研,英文)

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Simcor safely and effectively. See full prescribing information for Simcor.Simcor (simvastatin/niacin extended-release) Tablet, Film Coated, Extended Release for Oral useInitial U.S. Approval: 2008————— INDICATIONS AND USAGE ————— SIMCOR is a combination of simvastatin, an HMG-Co-A reductase inhibitor, and extended-release niacin (Niaspan), nicotinic acid. SIMCOR is indicated to:• Reduce elevated total–C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia andmixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate. (1.1) • Reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate. (1.1) Limitations of use:No incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin monotherapy has been established. (1.1)————— DOSAGE AND ADMINISTRATION ————— • SIMCOR should be taken at bedtime with a low-fat snack. (2)• Dose range: 500/20 mg to 2000/40 mg once daily. (2)• Initial dose for patients naïve to or switching from immediate-release niacin: 500/20 mg once daily. (2)• The initial dose for patients already receiving niacin extended-release should not exceed 2000/40 mg once daily. (2)• Maintenance dose: 1000/20 mg to 2000/40 mg once daily. (2)• Doses greater than 2000/40 mg daily are not recommended. (2)————— DOSAGE FORMS AND STRENGTHS ————— • Unscored film-coated tablets:500 mg niacin extended-release/20 mg simvastatin (3)750 mg niacin extended-release/20 mg simvastatin (3)1000 mg niacin extended-release/20 mg simvastatin (3)————— CONTRAINDICATIONS —————• Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4, 5.2)• Active peptic ulcer disease (4)• Arterial bleeding (4)• Women who are pregnant or may become pregnant (4, 8.1)• Nursing mothers (4, 8.3)• Known hypersensitivity to product components (4, 6.1)————— WARNINGS AND PRECAUTIONS ————— • Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses, advanced age (≥ 65), hypothyroidism, renal impairment, and concomitant use of cyclosporine, danazol,gemfibrozil, amiodarone, and verapamil and potent CYP3A4inhibitors. (5.1)• Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before andduring treatment. (5.2)• Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. Ifswitching from other niacin preparations, initiate with lowest SIMCOR dose; niacin extended-release can be converted at equivalent doses.(5.2)• Niacin extended-release can increase serum glucose levels. Glucose levels should be closely monitored in diabetic or potentially diabeticpatients particularly during the first few months of use. (5.3)————— ADVERSE REACTIONS —————The most common (incidence > 3%) adverse reactions with SIMCOR are flushing, headache, back pain, diarrhea, nausea, and pruritis. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Abbott Laboratories at 1-800-633-9110 or FDA at 1-800-FDA-1088 or/medwatch————— DRUG INTERACTIONS —————• Potent inhibitors of CYP 3A4: Combination increases simvastatin exposure. SIMCOR should not be used with potent inhibitors ofCYP3A4. (7.1)• Cyclosporine: Combination with SIMCOR should be avoided. (7.2) • Danazol: Combination with SIMCOR should be avoided. (7.2)• Amiodarone: Combination with SIMCOR should be limited to the 20 mg once daily dose of simvastatin. (7.3)• Verapamil: Combination with SIMCOR should be limited to the 20 mg once daily dose of simvastatin. (7.3)• Gemfibrozil: Combination with SIMCOR should be avoided. (7.4) • Fenofibrate: Combination with SIMCOR should be avoided. (7.4) • Coumarin anticoagulants: Combination prolongs INR. Achieve stable INR prior to starting SIMCOR. Monitor INR frequently until stableupon initiation or alteration of SIMCOR therapy. (7.7)————— USE IN SPECIFIC POPULATIONS ————— • Severe renal impairment (not on dialysis): SIMCOR should be used with extreme caution. (8.7)See 17 for PATIENT COUNSELING INFORMATIONFULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Patients with Hypercholesterolemia RequiringModifications of Lipid Profiles2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Myopathy/Rhabdomyolysis5.2 Liver Dysfunction5.3 Laboratory Abnormalities6 ADVERSE REACTIONS6.1 Clinical Studies Experience7 DRUG INTERACTIONS7.1 CYP3A4 Inhibitors7.2 Cyclosporine or Danazol7.3 Amiodarone or Verapamil7.4 Gemfibrozil and other Fibrates7.5 Propranolol7.6 Digoxin7.7 Coumarin Anticoagulants7.8 Aspirin7.9 Antihypertensive Therapy7.10 Bile Acid Sequestrants7.11 Other8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Gender8.7 Renal Impairment8.8 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment ofFertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Modifications of Lipid Profiles16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION17.1 Dosing Time17.2 Tablet Integrity17.3 Dosing Interruption17.4 Muscle Pain17.5 Flushing17.6 Use of Aspirin or other Non-InflammatoryMedication17.7 Diet17.8 Supplements17.9 Dizziness17.10 Diabetics17.11 Pregnancy17.12 Breastfeeding* Sections or subsections omitted from the full prescribing information are not listedFULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGETherapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.1.1 Patients with Hypercholesterolemia Requiring Modifications of Lipid ProfilesSIMCORSIMCOR is indicated to reduce total-C, LDL-C, Apo B , non-HDL-C, or TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson type IIa and IIb) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.Limitations of useNo incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin monotherapy has been established.2 DOSAGE AND ADMINISTRATIONSIMCOR should be taken as a single daily dose at bedtime, with a low fat snack. Patients not currently on niacin extended-release and patients currently on niacin products other than niacin extended-release should start SIMCOR at a single 500/20 mg tablet daily at bedtime [See Warnings and Precautions ( 5.2)]. The dose of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks - see Table 1. The recommended maintenance dose for SIMCOR is 1000/20 mg to 2000/40 mg (two 1000/20 tablets) once daily depending on patient tolerability and lipid levels. The efficacy and safety of doses of SIMCOR greater than 2000/40 mg daily have not been studied and are therefore not recommended. If SIMCOR therapy is discontinued for an extended period of time (> 7 days), re-titration as tolerated is recommended. SIMCOR tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.Table 1. Recommended niacin extended-release dosingWeek(s) Daily dose of niacin extended-releaseInitial Titration Schedule 1 to 4 500 mg5 to 8 1000 mg* 1500 mg* 2000 mg* After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increasedose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increasedmore than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended.Due to the increased risk of hepatotoxicity with other modified-release (sustained-release or time-release) niacin preparations or immediate-release (crystalline) niacin, SIMCOR should only be substituted for equivalent doses of niacin extended-release (NIASPAN).Flushing [See Adverse Reactions (6.1)] may be reduced in frequency or severity by pretreatment with aspirin or other non-steroidal anti-inflammatory drugs (approximately 30 minutes prior to SIMCOR dose). Flushing, pruritus, and gastrointestinal distress are also reduced by gradually increasing the dose of niacin (refer to Table 1) and avoiding administration on an empty stomach.3 DOSAGE FORMS AND STRENGTHSSIMCOR tablets are formulated for oral administration in the following strength combinations:Table 2. SIMCOR Tablet Strengths500mg/20mg 750mg/20mg 1000mg/20mgNiacin extended-release equivalent (mg) 500 750 1000simvastatin equivalent (mg) 20 20 20· 500 mg/20 mg blue unscored tablets debossed with 021 on one side and KOS on the other· 750 mg/20 mg blue unscored tablets debossed with 022 on one side and KOS on the other· 1000 mg/20 mg blue unscored tablets debossed with 023 on one side and KOS on the other4 CONTRAINDICATIONSSIMCOR is contraindicated in the following conditions:• Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels [See Warnings and Precautions ( 5.2)]• Patients with active peptic ulcer disease• Patients with arterial bleeding• Women who are pregnant or may become pregnant. SIMCOR may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase duringnormal pregnancy, and cholesterol or cholesterol derivatives are essential for fetaldevelopment. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primaryhypercholesterolemia therapy. There are no adequate and well-controlled studies of SIMCOR use during pregnancy; however in rare reports congenital anomalies were observed following intrauterine exposure to HMG-CoA reductase inhibitors. In rat and rabbit animal reproduction studies, simvastatin revealed no evidence of teratogenicity. There are no animal reproductive studies conducted with niacin. If SIMCOR is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. [See Use In Specific Populations (8.1)]• Nursing mothers. SIMCOR contains simvastatin and nicotinic acid. Nicotinic acid is excreted into human milk and it is not known whether simvastatin is excreted into human milk; howevera small amount of another drug in this class does pass into breast milk. Because of thepotential for serious adverse reactions in nursing infants, women who require SIMCORtreatment should not breastfeed their infants. [See Use In Specific Populations (8.3)] • Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including one of more of the following adverse reactions have been reported forsimvastatin and/or niacin extended-release: anaphylaxis, angioedema, urticaria, fever,dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, andflushing. [See Adverse Reactions (6.1)]5 WARNINGS AND PRECAUTIONSSIMCOR should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to SIMCOR, therapy with SIMCOR should be initiated at 500/20 mg and appropriately titrated to the desired therapeutic response. Doses of SIMCOR greater than 2000/40 mg are not recommended.5.1 Myopathy/RhabdomyolysisSimvastatinSimvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.As with other HMG-CoA reductase inhibitors, the risk of myopathy/rhabdomyolysis is dose related. In a clinical trial database in which 41,050 patients were treated with simvastatin with 24,747 (approximately 60%) treated for at least 4 years, the incidence of myopathy was approximately0.02%, 0.08%, and 0.53% at 20, 40, and 80 mg/day, respectively. In these trials, patients were carefully monitored and some interacting medicinal products were excluded.Potent inhibitors of CYP3A4: The risk of myopathy appears to be increased by high levels of HMG-CoA reductase inhibitory activity in plasma. Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which share this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy. These include cyclosporine, itraconazole, ketoconazole, and other antifungal azoles, the macrolide antibiotics erythromycin and clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, the antidepressant nefazodone, or large quantities of grapefruit juice (> 1 quart daily).The risk of myopathy/rhabdomyolysis is increased by concomitant use of simvastatin and, therefore, SIMCOR with the following:Potent inhibitors of cytochrome P-450 isoform, 3A4 (CYP 3A4):Itraconazole, ketoconazole, and other antifungal azolesMacrolide antibiotics erythromycin, clarithromycin, and telithromycinHIV protease inhibitorsAntidepressant nefazodoneGrapefruit juice in large quantities (> 1 quart daily)The use of SIMCOR concomitantly with these potent CYP3A4 inhibitors should be avoided. [See Drug Interactions (7.1)]Cyclosporine or Danazol: Simvastatin dose should not exceed 10 mg daily in combination with cyclosporine or danazol. Therefore, the combined used of SIMCOR with cyclosporine or danazol should be avoided. [See Drug Interactions (7.2)]Gemfibrozil: Simvastatin dose should not exceed 10 mg daily when concomitantly used with gemfibrozil. Therefore, the combined use of SIMCOR with gemfibrozil should be avoided. [See Drug Interactions (7.4)]Other Fibrates: Combined use of SIMCOR with drugs that cause myopathy/rhabdomyolysis when given alone, such as fibrates, should be avoided. [See Drug Interactions (7.4)]Amiodarone or Verapamil: The dose of the simvastatin component of SIMCOR should not exceed 20 mg in patients receiving amiodarone or verapamil concomitantly. The combined use of the simvastatin at doses higher than 20 mg daily with amiodarone or verapamil should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy. [See Drug Interactions (7.3)] SIMCORMyopathy and/or rhabdomyolysis have been reported when simvastatin is used in combination with lipid-altering doses (≥ 1 gram/day) of niacin. Physicians contemplating the use of SIMCOR, a combination of simvastatin and niacin, should weigh the potential benefits and risks, and should carefully monitor for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial month of treatment or during any period of upward dosage titration of either drug. Periodic determination of serum creatine kinase (CK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent myopathy.Patients starting therapy with SIMCOR should be advised of the risk of myopathy, and told to report promptly unexplained muscle pain, tenderness, or weakness. A CK level above 10 times ULN in a patient with unexplained muscle symptoms indicates myopathy. SIMCOR therapy should be discontinued if myopathy is diagnosed or suspected.In patients with complicated medical histories predisposing to rhabdomyolysis, such as renal insufficiency, dose escalation requires caution. Also, as there are no known adverse consequences of brief interruption of therapy, treatment with SIMCOR should be stopped for a few days before electivemajor surgery and when any major acute medical or surgical condition supervenes (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).5.2 Liver DysfunctionCases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses. Patients previously receiving niacin products other than niacin extended-release should be started on SIMCOR at the lowest recommended starting dose. [See Dosage and Administration (2)]SIMCOR should be used with caution in patients who consume substantial quantities of alcoholand/or have a past history of liver disease. Active liver disease or unexplained transaminase elevations are contraindications to the use of SIMCOR. [See Contraindications (4)]Niacin extended-release and simvastatin can cause abnormal liver tests. In a simvastatin-controlled, 24 week study with SIMCOR in 641 patients, there were no persistent increases (to more than 3x the ULN) in serum transaminases. In three placebo-controlled clinical studies of extended-release niacin there were no patients with normal serum transaminases levels at baseline who experienced elevations to more than 3x the ULN. Persistent increases (to more than 3x the ULN) in serum transaminases have occurred in approximately 1% of patients who received simvastatin in clinical studies. When drug treatment was interrupted or discontinued in these patients, the transaminases levels usually fell slowly to pretreatment levels. The increases were not associated with jaundice or other clinical signs or symptoms. There was no evidence of hypersensitivity.Liver function tests should be performed on all patients during therapy with SIMCOR. It is recommended that liver function tests be performed before treatment begins, every 12 weeks for the first 6 months, and periodically thereafter (e.g., at approximately 6-month intervals). Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality returns to normal. Should an increase in transaminase levels of more than 3x ULN persist, or if transaminase elevations are associated with symptoms of nausea, fever, and/or malaise, withdrawal of SIMCOR therapy is recommended.5.3 Laboratory AbnormalitiesIncrease in Blood Glucose: Niacin treatment can increase fasting blood glucose. In a simvastatin-controlled, 24-week study with SIMCOR the change from baseline in glycosylated hemoglobin levels was 0.2% for SIMCOR-treated patients and 0.2% for simvastatin-treated patients. Diabetic or potentially diabetic patients should be observed closely during treatment with SIMCOR, particularly during the first few months of therapy. Adjustment of diet and/or hypoglycemic therapy or discontinuation of SIMCOR may be necessary.Reduction in platelet count: Niacin can reduce platelet count. In a simvastatin-controlled, 24-week study with SIMCOR the mean percent change from baseline for patients treated with 2000/40 mg daily was -5.6%.Increase in ProthrombinTime (PT): Niacin can cause small increases in PT . In a simvastatin-controlled, 24-week study with SIMCOR this effect was not seen.Increase in Uric Acid: Elevated uric acid levels have occurred with niacin therapy. In a simvastatin-controlled, 24-week study with SIMCOR this effect was not seen. Nevertheless, in patients predisposed to gout, SIMCOR therapy should be used with caution.Decrease in Phosphorus: Small dose-related reductions in phosphorous levels were seen in clinical studies with niacin. In a simvastatin-controlled, 24-week study with SIMCOR this effect was not seen.6 ADVERSE REACTIONSOverviewIn a controlled clinical study, 14% of patients randomized to SIMCOR discontinued therapy due to an adverse event. Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions, occurring in up to 59% of patients treated with SIMCOR. Spontaneous reports with niacin extended-release and clinical studies of SIMCOR suggest that flushing may be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, chills, and/or edema.6.1 Clinical Studies ExperienceSIMCORBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.The safety data described below reflect exposure to SIMCOR in 403 patients in a controlled study for a period of 6 months.Flushing: Flushing (warmth, redness, itching and/or tingling) occurred in up to 59% of patients treated with SIMCOR. Flushing resulted in study discontinuation for 6.0% of patients.More Common Adverse Reactions: In addition to flushing, adverse reactions occurring in ≥ 3% of patients (irrespective of investigator causality) treated with SIMCOR are shown in Table 3 below:Table 3. Adverse Reactions Occurring in ≥ 3% of Patients in a Controlled Clinical TrialAdverse EventTotal Number of Patients SIMCOR overall *N=403Simvastatin overall **N=238Headache 18 (4.5%) 11 (4.6%)Pruritus 13 (3.2%) 0 (0.0%)Nausea 13 (3.2%) 10 (4.2%)Back Pain 13 (3.2%) 5 (2.1%)Diarrhea 12 (3.0%) 7 (2.9%)* SIMCOR overall included all doses from 500/20 mg to 2000/40 mg** Simvastatin overall included 20 mg, 40 mg, and 80 mg dosesSimvastatinIn pre-marketing controlled clinical studies and their open extensions (2,423 patients with mean duration of follow-up of approximately 18 months) 1.4% of patients discontinued due to adverse reactions. The most commonly reported adverse reactions (incidence > 1%) in simvastatin controlled clinical trials were: headache (3.5%), abdominal pain (3.5%), constipation (2.3%), upper respiratory infection (2.1%), diarrhea (1.9%), and flatulence (1.9%).Niacin Extended-ReleaseIn placebo-controlled clinical trials (n=245), flushing episodes were the most common treatment-emergent adverse events (up to 88% of patients) for niacin extended-release. Other adverse events occurring in 5% or greater of patients treated with niacin extended-release are headache (9%),diarrhea (7%), nausea (5%), rhinitis (5%), and dyspepsia (4%) at a maintenance dose of 1000mg daily.Clinical Laboratory Abnormalities:SIMCORChemistryElevations in serum transaminases [See Warnings and Precautions (5.2)], CK, fasting glucose, uric acid, alkaline phosphatase, LDH, amylase, γ-glutamyl transpeptidase, bilirubin, and reductions in phosphorus, and abnormal thyroid function tests.HematologyReductions in platelet counts and prolongation of PT. [See Warnings and Precautions (5.3)]Postmarketing ExperienceBecause the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.SimvastatinThe following additional adverse reactions have been identified during postapproval use of simvastatin. Hypersensitivity reaction including one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, vasculitis, purpura, thrombocytopenia, leucopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, photosensitivity, chills, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, urticaria, fever, dyspnea, and arthralgia; pancreatitis, hepatitis, hepatic failure, pruritus, cataracts, polymyositis, dermatomyositis, polymyalgia rheumatica, global amnesia, tendon rupture, peripheral neuropathy, memory impairment.NIASPANThe following additional adverse reactions have been identified during post-approval use of NIASPAN. Hypersensitivity reaction including one or more of the following features: anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, vesiculobullous rash, palpitations, syncope, hypotension, orthostasis, decreased glucose tolerance, gout, hepatitis, skin discoloration, rhabdomyolysis, amblyopia, and insomnia.7 DRUG INTERACTIONSNo drug interaction studies were conducted with SIMCOR. However, the following interactions have been noted with the individual components of SIMCOR:Simvastatin7.1 CYP3A4 InhibitorsSimvastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of CYP3A4. Simvastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4.Potent inhibitors of CYP3A4 include:Itraconazole, ketoconazole, and other antifungal azoles,Macrolide antibiotics erythromycin, clarithromycin, and telithromycin,HIV protease inhibitors,Antidepressant nefazodone,Grapefruit juice in large quantities (> 1 quart daily).Potent inhibitors of CYP3A4 increase the risk of myopathy by reducing the elimination of simvastatin. Hence when simvastatin is used with a potent inhibitor of CYP3A4, elevated plasma levels of HMG-CoA reductase inhibitory activity can increase the risk of myopathy and rhabdomyolysis, particularly with higher doses of simvastatin. [See Warnings and Precautions (5.1)]Serious skeletal muscle disorder, e.g., rhabdomyolysis, have been reported during concomitant therapy of simvastatin or other HMG-CoA reductase inhibitors with cyclosporine, danazol, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, telithromycin, nefazodone or HIV protease inhibitors.Concomitant use of drugs labeled as potent inhibitors of CYP3A4 should be avoided unless the benefits of combined therapy outweigh the increased risk. If treatment with itraconazole, ketoconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with SIMCOR should be suspended during the course of treatment.7.2 Cyclosporine or DanazolAlthough the mechanism is not fully understood, cyclosporine has been shown to increase the area under the curve (AUC) of HMG-CoA reductase inhibitors. The increase in AUC for simvastatin acid is presumably due, in part, to inhibition of CYP3A4. The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine or danazol particularly with higher doses of simvastatin. [See Warnings and Precautions (5.1)]7.3 Amiodarone or VerapamilThe risk of myopathy/rhabdomyolysis is increased by concomitant administration of amiodarone or verapamil with higher doses of simvastatin. [See Warnings and Precautions (5.1)]7.4 Gemfibrozil and other FibratesCoadministration of gemfibrozil (600 mg twice daily for 3 days) with simvastatin (40 mg daily) resulted in clinically significant increases in simvastatin acid AUC (185%) and peak plasma concentration(C max,112%), possibly due to inhibition of simvastatin acid glucuronidation by gemfibrozil. The increase in simvastatin exposure increases the risk of myopathy when coadministred with gemfibrozil. The combined use of SIMCOR with gemfibrozil should be avoided [See Warnings and Precautions (5.1)]. The risk of myopathy also increases to a lesser extent when simvastatin is used in combination with other fibrates. Coadministration of 160 mg fenofibrate daily with 80 mg simvastatin daily for 7 days had no effect on plasma AUC (and C max) of either total HMG-CoA reductase inhibitory activity or fenofibric acid; there was a modest reduction (approximately 35%) of simvastatin acid which was not considered clinically significant.7.5 PropranololIn healthy male volunteers there was a significant decrease in mean C max, but no change in AUC, for simvastatin total and active inhibitors with concomitant administration of single doses of simvastatin and propranolol. The clinical relevance of this finding is unclear. The pharmacokinetics of the enantiomers of propranolol were not affected.7.6 DigoxinConcomitant administration of a single dose of digoxin in healthy male volunteers receiving simvastatin resulted in a slight elevation (less than 0.3 ng/mL) in digoxin concentrations in plasma (as measured by a radioimmunoassay) compared to concomitant administration of placebo and digoxin. Patients taking digoxin should be monitored appropriately when SIMCOR is initiated.。

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头孢咪唑cefpimizole头孢米诺cefminox头孢尼西cefonicid头孢帕罗cefaparole头孢哌酮cefoperazone头孢匹胺cefpiramide头孢匹林cefapirin；cephapirin头孢匹罗cefpirome头孢羟氨苄cefadroxil头孢曲秦cefatrizine头孢曲松ceftriaxone头孢屈洛cefedrolor头孢瑞南cefluprenam头孢噻啶cefaloridne；cephaloridine 头孢噻吩cefalotin；cephalothin头孢噻呋ceftiofur头孢噻利cefoselis头孢噻林ceftiolene头孢噻肟cefotaxime头孢噻氧ceftioxide头孢三唑cefetrizole头孢沙定cefroxadine头孢舒米cefsumide头孢他啶ceftazidime头孢他美cefetamet头孢特仑cefteram头孢替安cefotiam头孢替考cefetecol头孢替坦cefotetan头孢替唑ceftezole头孢托仑cefditoren头孢维曲cefivitril头孢西丁cefoxitin头孢西酮cefazedone头孢乙腈cefacetrile头孢唑兰cefozopran头孢唑林cefazolin；cephazolin 头孢唑南cefuzonam头孢唑肟ceftizoxime透明糖酶hyalosidase土荆芥油chenopodium oil土霉素oxytetracycline托巴茶碱torbafylline托吡卡胺tropicamide托吡哌唑tolpiprazole托吡酯topiramate托波力农toborinone托泊地芬tropodifene托布特罗tobuterol托定磷toldimfos托法胺tolfamide托非索泮tofisopam托芬那酸tolfenamic acid托芬那辛tofenacin托氟沙星tosufloxacin托磺鲁尔tosulur托加比特tolgabide托卡朋tolcapone托莰非tocamphyl托考贝特tocofibrate托可芬酯tocofenoxate托可醌tocopherylquinone托可索仑tocofersolan；tocophersolan 托可维a酸tretinoin tocoferil托喹嗪toquizine托拉芬群tolafentrine托拉塞米torasemide托立司酮toripristone托利卡因tolycaine托利洛尔toliprolol托利咪酮tolimidone托林达酯tolindate托鲁膦酸toluylphosphenic acid 托鲁司特tomelukast托洛氯铵tolonium chloride托洛氯醇toloxychlorinol托洛尼定tolonidine托马霉素tomamycin托美丁tolmetin托莫鲁胺tomoglumide托莫普罗tomoxiprole托莫西汀tomoxetine托那哌嗪tolnapersine托那佐辛tonazocine托萘酯tolnaftate托尼达明tolnidamine托帕朵tolpadol托哌酮tolperisone托喷磺脲tolpentamide托硼生tolboxane托品巴酯tropabazate托品林tropigline托普罗宁tolpronine托普帕敏tolpropamine托普雄酮topterone托曲珠利toltrazuril托屈嗪todralazine托瑞米芬toremifene托瑞司他tolrestat托沙克肽octacosactrine；tosactide 托特罗定tolterodine托烷色林tropanserin托烷司琼tropisetron托西芬tosifen托西拉酯tolciclate托西米定xylamidine tosilate托西曲喹铵trethinium tosilate托西曲咯铵troxypyrrolium tosilate 托西曲乙铵troxonium tosilate托西硝乙胺itramine tosilate托西溴苄铵bretylium tosylate托西溴苄铵bretylium tosilate托西依米铵emilium tosilate托扎啉酮thozalinone；tozalinone 妥布氯唑tubulozole妥布霉素tobramycin妥伐替丁tuvatidine妥卡雷琐tucaresol妥卡尼tocainide妥拉磺脲tolazamide妥拉洛尔tolamolol妥拉唑林tolazoline妥氯西泮tuclazepam妥罗雄脲turosteride妥洛帕泛tulopafant妥洛特罗tulobuterol妥韦单抗tuvirumab哇洛凡valofane万古霉素vancomycin微晶纤维素microcrystalline cellulose 韦罗肟viroxime维a酸tretinoin维吖啶velnacrine维胺酯viaminate维丙胺diisopropylamine ascorbate 维布沙星vebufloxacin维达洛芬vedaprofen维吉霉素virginiamycin维库溴铵vecuronium bromide维喹地尔viquidil维喹啉viqualine维拉必利veralipride维拉朵林veradoline维拉雷琐velaresol维拉帕米verapamil维拉烟肼verazide维立洛泮verilopam维鲁司特verlukast维罗茶碱verofylline维罗卡宁verocainine维洛沙秦viloxazine维米醇viminol维前列醇viprostol维曲布汀vetrabutine维塞胺versetamide维生素a retinol；vitamin a维生素b1 thiamine；vitamin b1维生素b12 cyanocobalamin；vitamin b12维生素b2 riboflavin；vitamin b2维生素b6 pyridoxine；vitamin b6维生素c ascorbic acid；vitamin c维生素c钠sodium ascorbate维生素d2 calciferol；ergocalciferol；vitamin d2维生素d3 cholecalciferol；colecalciferol；vitamin d3维生素e tocopherol；vitamin e维生素k1 phytomenadione；phytonadione；vitamin k1维生素u methiosulfonium chloride；methylmethionine sulfonium chloride；vitamin u维司茶碱visnafylline维司力农vesnarinone维司那定visnadine维司托隆statolon；vistatolon维替泊芬verteporfin伪麻黄碱pseudoephedrine胃蛋白酶pepsin胃酶抑素pepstatin文拉法辛venlafaxine文立替丁venritidine肟硫磷phoxim肟莫南oximonam乌倍他索ulobetasol乌苯美司ubenimex乌比新定ubisindine乌达西泮uldazepam乌非拉唑ufiprazole乌芬那酯ufenamate乌拉地尔urapidil乌拉立肽ularitide乌拉莫司汀uracil mustard；uramustine 乌拉坦urethane乌洛托品methenamine；urotropine乌美螺酮umespirone乌诺前列酮unoprostone乌瑞磷uredofos乌瑞替派uredepa乌司他丁ulinastatin乌替普利utibapril乌替普利拉utibaprilat无定形吉他林gitalin amorphous五氟拉诺pentafluranol五氟利多penfluridol五甲溴铵pentamethonium bromide五氯硝苯quintozene五肽胃泌素pentagastrin戊胺卡因amydricaine戊巴比妥mebumal；pentobarbital；pentobarbitone 戊波那胺pentanobornamide戊地胺valdetamide戊二醛glutaral戊氟噻嗪penflutizide戊甲睾醇penmesterol戊间甲酚amylmetacresol戊康唑valconazole戊吗酮pentamorphone戊诺酰胺valnoctamide戊哌醇valperinol戊哌立特pentapiperide戊齐酮pentizidone戊前列烯penprostene戊曲酯valtrate戊沙溴铵valethamate bromide戊四氮pentetrazole戊四硝酯pentaerithrityl tetranitrate；pentaerythrityl tetranitrate；pentanitrol戊四烟酯niceritrol戊酸雌二醇estradiol valerate戊酮酸钙calcium levulinate戊烯比妥vinbarbital；vinbarbitone戊硝醇pentrinitrol戊氧氯醛penthrichloral西阿尼醇cianidanol西巴西坦cebaracetam西苯唑啉cibenzoline西吡氯铵cetylpyridinium chloride西波吡啶sibopirdine西布曲明sibutramine西地碘cydiodine西地芬戈cedefingol西地霉素sedecamycin西地那非sidenafil西地孕酮cismadinone西多福韦cidofovir西多塞平cidoxepine 西法哌嗪sifaprazine 西高苷siagoside西甲硅油simethicone 西卡宁siccanin西卡哌隆cicarperone 西卡前列素cicaprost 西可奈德cicortonide 西拉多巴ciladopa西拉马朵ciramadol西拉普利cilazapril西拉普利拉cilazaprilat 西拉唑啉cirazoline西兰司琼cilansetron 西立伐他汀cerivastatin 西鲁唑啉cilutazoline 西氯他宁cicletanine 西罗霉素cirolemycin 西罗莫司sirolimus西罗普利ceronapril西洛巴明cilobamine西洛芬净cilofungin西洛雷定cilobradine 西洛他唑cilostazol西洛酰胺cilostamide 西马多丁cemadotin西马特罗cimaterol西美莫辛cimemoxin西美帕醇cimepanol西美曲特simetride西孟旦simendan西眯替丁cimetidine西莫白介素celmoleukin 西莫沙酮cimoxatone 西莫司亭cilmostim西那利定thenalidine 西那林cynarine西那洛尔cinamolol西那司特cinalukast西奈芬净sinefungin奈氟齐特neflumozide 奈福泮nefopam奈康唑neticonazole奈可吡旦necopidem奈喹酯methyl benzoquate；nequinate 奈拉米诺neraminol奈拉西坦nebracetam奈来扎林nelezaprine奈立膦酸neridronic acid奈立索泮nerisopam奈马克丁nemadectin奈马唑啉nemazoline奈莫必利nemonapride奈莫柔比星nemorubicin奈莫司汀neptamustine；pentamustine 奈帕拉唑nepaprazole奈帕咪唑napamezole奈哌那隆nepinalone奈沙地尔nesapidil奈沙加群napsagatran奈司茶碱nestifylline奈索帕米nexopamil奈索司坦nesosteine奈替夫定netivudine奈替克新neltenexine奈替米星netilmicin奈托比胺netobimin奈韦拉平nevirapine奈西利定nexeridine萘苯诺酮nafenodone萘吡莫司napirimus萘吡坦napitane萘丙多昔naprodoxime萘氮芥chlornaphazine萘丁美酮nabumetone萘啶酸nalidixan；nalidixic acid萘二磺乙乳胆铵aclatonium napadisilate 萘非可特naflocort萘非洛尔nafetolol萘酚平nafenopin萘夫西林nafcillin萘呋胺naftidrofuryl萘福昔定nafoxidine萘甲羟胺nafomine萘甲唑林naphazoline萘克沙朵nafoxadol萘醌腙naftazone萘拉诺naranol萘咪酮nafimidone萘莫司他nafamostat萘帕他定napactadine萘哌地尔naftopidil萘普生naproxen萘普索naproxol萘肽磷naftalofos萘替芬naftifine萘托酮naphthonone；naphtonone萘维林nafiverine萘肟洛尔nadoxolol南力农nanterinone南曲朵nantradol脑膜炎球菌多糖菌苗meningococcal polysaccharide vaccine尼阿比妥nealbarbital；neallymal尼尔雌醇nilestriol尼伐地平nilvadipine尼伐可醇nivacortol；nivazol尼非卡兰nifekalant尼芬净nifungin尼芬那宗nifenazone尼氟酸niflumic acid尼古地平niguldipine尼古丁nicotine尼海屈腙nihydrazone尼卡地平nicardipine尼卡非宁nicafenine尼卡那汀nicanartine尼卡普醇nicainoprol尼可贝特nicofibrate尼可待因nicocodine尼可地尔nicorandil尼可呋糖nicofuranose尼可呋酯nicofurate尼可复林nicopholine尼可硫腙nicothiazone尼可氯酯nicoclonate尼可马特nicoxamat尼可吗啡nicomorphine尼可莫尔nicomol尼可奈德nicocortonide尼可刹米nicethamide；nikethamide尼可占替诺xantinol nicotinate 尼克昔酸nixylic acid尼克吲哚nictindole尼拉伏林niravoline尼拉霉素nebramycin尼来前列素nileprost尼立达唑niridazole尼鲁地平niludipine尼鲁米特nilutamide尼马宗nimazone尼麦角林nicergoline尼美舒利nimesulide尼美西泮nimetazepam尼米旦nimidane尼莫地平nimodipine尼莫司汀nimustine尼莫唑nimorazole尼哌拉唑nilprazole尼培替丁niperotidine尼普地洛nipradilol尼普拉嗪niaprazine尼屈昔腙nidroxyzone尼群地平nitrendipine尼司特林nisterime尼司特罗nisbuterol尼索氨酯nisobamate尼索地平nisoldipine尼索西汀nisoxetine尼维美酮nivimedone尼西维林niceverine尼亚拉胺nialamide尼扎替丁nizatidine尼唑苯酮nizofenone鸟氨加压素ornipressin鸟氨酸ornithine尿促卵泡素urofollitropin尿促性素menotrophin；menotropins 尿激酶urokinase尿囊素allantoin尿囊素铝aldioxa尿素carbamide；urea脲贝特urefibrate凝血酶thrombin牛蛋氨生长素sometribove牛痘苗smallpox vaccine牛度生长素somidobove牛磺罗定taurolidine牛磺莫司汀tauromustine牛磺司坦taurosteine牛磺酸taurine牛磺硒胆酸tauroselcholic acid牛亮氨生长素somavubove牛瑞生长素somagrebove纽帕泛nupafant奴芬克索nufenoxole奴氯美酮nuclomedone奴文西平nuvenzepine诺柏斯汀noberastine诺丙磺胺noprylsulfamide诺勃酮norbolethone；norboletone 诺布君norbudrine诺次黄嘌呤nosantine诺大麻nonabine诺非卡尼nofecainide诺氟沙星norfloxacin诺氟烷norflurane诺考达唑nocodazole诺拉霉素nogalamycin诺来替酚norletimol诺利溴铵nolinium bromide诺龙nandrolone诺氯前列素nocloprost诺美立定nomelidine诺美沙朵noracymethadol诺美孕酮nomegestrol诺米芬辛nomifensine诺那吡胺nonapyrimine诺那莫林nonathymulin诺那哌隆nonaperone诺匹哌酮norpipanone诺瑞昔胺noreximide诺司替勃norclostebol诺替西泮nortetrazepam诺西肽nosiheptide诺昔硫脲noxythiolin；noxytiolin 诺昔替林noxiptiline诺香草胺nonivamide诺乙烯酮norvinisterone诺乙雄龙norethandrolone 诺孕酪norgestimate诺孕美特norgestomet诺孕酮norgesterone诺孕烯酮norgestrienone偶氮丝氨酸azaserine帕苯达唑parbendazole帕地洛parodilol帕地马酯padimate帕地霉素paldimycin帕伐醌parvaquone帕非洛尔pafenolol帕肝素钠parnaparin sodium 帕高洛尔pargolol帕戈隆pagoclone帕吉林pargyline帕吉维林pargeverine帕康唑parconazole帕拉米松paramethasone帕拉曲近palatrigine帕拉塞嗪parathiazine帕拉沙酮paraxazone帕立太特pareptide帕利那韦palinavir帕罗西汀paroxetine帕洛地平palonidipine帕洛诺司琼palonosetron帕马苷pamaqueside帕马喹pamaquine；plasmoquine 帕马洛尔pamatolol帕马溴pamabrom帕米格雷pamicogrel帕米磷酸pamidronic acid帕莫司他patamostat帕莫酸palmoxiric acid帕那美新panamesine帕那普隆panadiplon帕尼培南panipenem帕奴拉明panuramine帕诺米芬panomifene帕秦克隆pazinaclone帕曲星partricin帕沙马酯paxamate帕沙米特parsalmide帕司烟肼pasiniazid帕西他沙parcetasal帕硝唑panidazole帕折普汀pazelliptine帕珠沙星pazufloxacin帕佐昔特pazoxide哌巴昔嗪pibaxizine哌苯甲醇pipradrol哌丙呋罗piprofurol哌泊非嗪pipofezine哌泊噻嗪pipothiazine哌泊噻嗪pipotiazine哌泊舒凡piposulfan哌泊索仑pipoxolan哌泊他酮pipoctanone哌泊昔秦pipoxizine哌泊溴烷pipobroman哌布宗pipebuzone哌醋茶碱acefylline piperazine 哌地马朵pipradimadol哌丁茶碱perbufylline哌多卡因paridocaine哌多明pirsidomine哌法宁pifarnine哌芬尼多piperphenidol哌芬新perafensine哌芬酯pifenate哌福地尔perfomedil哌福肟pifoxime哌海菜碱piprinhydrinate哌甲酯methylphenidate；methylphenidylacetate 哌腈米特pirinitramide；piritramide哌卡嗪pecazine哌考环素pecocycline哌克太尔pexantel哌克昔林perhexiline哌库碘铵piprocurarium iodide哌库溴铵pipecuronium bromide哌夸林pipequaline哌喹piperaquine哌喹齐尔piquizil哌喹新peraquinsin哌拉平perlapine哌拉齐通prazitone哌拉斯汀perastine哌拉替考pipratecol哌拉替唑peratizole哌拉肟peradoxime哌拉西林piperacillin 哌拉酰胺piperamide 哌立度酯piperidolate 哌立索唑perisoxal哌立酮piperylone哌氯必利peralopride 哌氯定picloxydine哌氯朋peraclopone哌仑西平pirenzepine 哌罗卡因piperocaine 哌罗克生piperoxan哌罗匹隆perospirone 哌马朵pipramadol哌马斯汀bermastine 哌美克隆pimeclone哌美立特pemerid哌美他嗪perimetazine 哌莫硝唑pimonidazole哌诺地尔pitenodil哌诺卡因pinolcaine哌普唑林piprozolin哌嗪piperazine哌嗪依地酸钙piperazine calcium edetate哌氰嗪periciazine；pericyazine；propericiazine 哌沙酯pipethanate哌替啶meperidine；pethidine哌妥酯pituxate哌西那朵picenadol哌西他嗪piperacetazine哌香豆司特picumast哌氧平pinoxepin哌唑嗪furazosin；prazosin潘必啶pempidine泮加酸pangamic acid泮考必利pancopride泮库溴铵pancuronium bromide泮托拉唑pantoprazole培哚普利perindopril培哚普利拉perindoprilat培氟沙星pefloxacin培高白介素pegaldesleukin 培高利特pergolide培高特酯pegoterate培戈汀pegorgotein培加酶pegademase培拉嗪perazine培兰色林pelanserin培力农pelrinone培利霉素peliomycin培磷酰胺perfosfamide培洛霉素peplomycin培美酸pemedolac培门冬酶pegaspargase培莫环素penimocycline 培那西林penamecillin培尼洛尔penirolol培曲氯醛petrichloral培维a pelretin培西洛星pecilocin沛马沙星premafloxacin 喷贝特ponfibrate喷布洛尔penbutolol喷地肽pendetide喷吉妥辛pengitoxin喷硫平pentiapine喷曲肽pentetreotide喷噻溴铵penthienate bromide喷沙西林penethacillin；penethamate喷司他丁pentostatin喷他氨酯pentabamate喷他胺pentalamide喷他喹pentaquine喷他氯铵pentacynium chloride喷他霉素pentamycin喷他脒pentamidine喷他莫生pentamoxane喷他孕酮pentagestrone喷他佐辛pentazocine喷替茶碱pentifylline喷替吉肽pentigetide喷替米星pentisomicin喷替酸pentetic acid喷替酸锝[99mtc] technetium[99mtc] pentetate 喷替酸钙钠calcium trisodium pentetate喷替酸镱[169yb] ytterbium pentetate[169yb] 喷替酸铟[113min] indium pentetate[113min] 喷替索胺pentisomide喷托雷司pentorex喷托孟pentomone喷托普利pentopril喷托维林carbetapentane；pentoxyverine 喷昔洛韦penciclovir喷辛溴铵penoctonium bromide硼[10b]卡钠sodium borocaptate[10b]硼砂borax硼酸boric acid硼酸苯汞phenylmercuric borate匹氨西林pivampicillin匹贝卡pibecarb匹度苯宗pidobenzone匹多卡因piridocaine匹多莫德pidotimod匹多他莫pidolacetamol匹尔屈嗪pildralazine匹伐加宾pivagabine匹伐依替福林etilefrine pivalate匹非克索pifexole匹伏普利pivopril匹伏替pivoxetil匹伏西泮pivoxazepam匹卡贝特picafibrate匹考哌林picoperine匹考齐特picobenzide匹考群picotrin匹可磷酸钠sodium picofosfate匹可硫酸钠sodium picosulfate匹喹酮piquindone匹立尼酸pirinixic acid匹立昔尔pirinixil匹立溴铵pyrithidium；pyritidium bromide 匹仑哌隆pirenperone匹罗西林piroxicillin匹罗昔酮piroximone匹罗酯pirolate匹马吉定pimagedine匹美茶碱pimefylline匹美劳肽pimelautide匹美噻吨pimethixene匹美汀pimetine匹美西林pivmecillinam匹美酰胺pimetremide匹米诺定piminodine匹米前列素pimilprost匹莫苯pimobendan匹莫林pemoline匹莫齐特pimozide匹那朵林pinadoline匹那西泮pinazepam匹哌氮酯pipazetate；pipazethate 匹哌环素pipacycline匹哌马嗪pipamazine匹泮哌隆pipamperone匹瑞洛尔pirepolol匹维溴铵pinaverium bromide匹戊肼pivhydrazine匹西雷司picilorex嘌罗霉素puromycin嘌嘧替派pumitepa平卡尼pincainide平阳霉素bleomycin a5泼那扎特prednazate泼那唑啉prednazoline泼尼卡酯prednicarbate泼尼立定prednylidene泼尼莫司汀prednimustine泼尼松prednisone泼尼松龙prednisolone泼尼索酯prednisolamate破伤风抗毒素tetanus antitoxin破伤风类毒素tetanus toxoid扑米酮primidone扑灭司林permethrin葡胺苯砜glucosulfone葡庚糖酐铁gleptoferron葡庚糖酸锝[99mtc] technetium[99mtc] gluceptate 葡庚糖酸钙calcium glucoheptonate葡磺胺glucosulfamide葡甲胺meglumine葡柳铝酸钠sodium glucaspaldrate葡铝酸钾potassium glucaldrate葡罗酰胺glucuronamide葡美辛glucametacin葡欧鼠李苷glucofrangulin葡醛内酯glucurolactone葡醛酸钠sodium glucuronate葡乳醛酸钙calcium glubionate葡索铁glusoferron葡萄糖dextrose；glucose葡萄糖酸胆碱choline gluconate葡萄糖酸钙calcium gluconate葡萄糖酸钾potassium gluconate葡萄糖酸锑钠sodium stibogluconate 葡萄糖酸锌zinc gluconate葡萄糖酸亚铁ferrous gluconate葡烟酯glunicate葡烟腙gluconiazone；glyconiazid 普地利定prodilidine普地哌隆prideperone普伐他汀pravastatin普呋罗林prifuroline普卡霉素mithramycin；plicamycin 普克罗米probicromil普拉贝脲plafibride普拉地平pranidipine普拉朵林pravadoline普拉睾酮prasterone普拉克索pramipexole普拉氯铵pranolium chloride 普拉洛尔practolol普拉洛芬pranoprofen普拉那西匹pranazepide普拉诺柳pranosal普拉维林pramiverine普拉西泮prazepam普拉西平prazepine普拉西坦pramiracetam普兰林肽pramlintide普兰品prampine普劳拉星plauracin普劳诺托plaunotol普立地芬pridefine普立地诺pridinol普立非酮prifelone普立哌隆primaperone普立昔单抗priliximab普利霉素primycin普林米特prinomide普啉索旦prinoxodan普硫地尔pretiadil普卢利沙星prulifloxacin普鲁卡因procaine普鲁卡因胺procainamide普鲁卡因青霉素procaine benzylpenicillin普鲁索纳明plusonermin普仑司特pranlukast普罗比妥钠probarbital sodium普罗布考probucol普罗雌烯promestriene普罗地芬proadifen普罗地平prodipine普罗碘铵prolonium iodide普罗度酸prodolic acid普罗法朵profadol普罗啡烷proxorphan普罗吩胺ethopropazine；profenamine；prophenamine 普罗庚嗪proheptazine普罗克生proroxan普罗喹宗proquazone药品名称中英文词汇七相关内容:。

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Wuhan Biocar Bio-Pharmaceutical CO.,Ltd
Certificate Of Analysis

Product Name
Sitagliptin
CAS No. 486460-32-6 Date Of Producing 2014.07.13
Batch No. 140713 Date Of Issue 2014.07.13
Source API workshop Date Of Expiry 2015.07.12
Package 15kg Reference Standard In-house standard
items specification Results
Appearance
White or almost white powder
Complies

Identification H-NMR, MS
Complies

Heavy metals ≤20ppm
Complies

Residue on ignition ≤0.1% 0.01%
Chiral impurity No more than 1.0% 0.01%
Specific rotation -18.0º～-23.0º（C=1,water）
-21.15

Related impurity
Total impurity no more than 1.0% 0.11%
Single impurity no more than 0.5% 0.02%
Assay(HPLC) 98.0%～102.0% 99.89%
Conclusion：The above substance has been tested according to In-house Standard, and it meets
requirements.

Analyst: Luoxin Checker: Lianghui Q.C.Director: Gaojin
Wuhan Biocar Bio-Pharmaceutical CO.,Ltd
Certificate Of Analysis

品名
西他列汀
CAS No. 486460-32-6 生产日期 2014.07.13
批号 140713 检测日期 2014.07.13
来源原料药合成车间有效日期 2015.07.12
包装 15kg 质量标准企业标准
检测项目检测指标检测结果
外观白色或类白色粉末符合
鉴别 H-NMR, MS
符合

重金属含量 ≤20ppm
符合

炽灼残渣 ≤0.1% 0.01%
手性杂质含量 ≤ 1.0% 0.01%
比旋光度 -18.0º～-23.0º（C=1,water）
-21.15

相关杂质
总杂 ≤ 1.0% 0.11%
单杂 ≤ 0.5% 0.02%
纯度(HPLC) 98.0%～102.0% 99.89%

结论：经检验，该产品符合企业标准。

分析员:罗欣核验员: 梁辉质检主管：高进