盐酸氨基葡萄糖USP质量标准翻译
氨基葡萄糖硫酸钠盐USP32标准
氨基葡萄糖硫酸钠盐U S P32标准Glucosamine Sulfate Sodium Chloride(C6H14NO5)2SO4·2NaCl 573.31Bis(d-Glucose, 2-amino-2-deoxy-), sulfate sodium chloride complex.Bis(2-Amino-2-deoxy- -d-glucopyranose) sulfate sodium chloride complex (-,-) [38899-05-7].» Glucosamine Sulfate Sodium Chloride contains not less than 98.0 percent a nd not morethan 102.0 percent of (C6H14NO5)2SO4·2NaCl calculated on the dried basis. Packaging and storage— Preserve in tight, light-resistant containers.USP Reference standards 11—USP Glucosamine Hydrochloride RS .Identification—A: Infrared Absorption 197K.Test solution— Transfer about 50 mg of Glucosamine Sulfate Sodium Chlorid e to a centrifuge tube,and dissolve in 2 mL of water. Add about 0.5 mL of barium chloride TS, and c entrifuge.Evaporate the supernatant, and dry the residue at 105 for 2 hours. The IR spe ctrum correspondsto that of a similar preparation of USP Glucosamine Hydrochloride RS, except that the additionof barium chloride TS is omitted.B: It meets the requirements of the tests for Chloride 191 and Sodium 191. C: The retention time of the major peak in the chromatogram of the Assay pre paration correspondsto that in the chromatogram of the Standard preparation, as obtained in the As say.D: In the test for the Content of sulfate, after the addition of barium chloride T S, a whiteprecipitate is formed.Specific rotation 781S: between +50.0 and +55.0.Test solution: 35 mg per mL. Measure the specific rotation 3 hours after sampl e preparation.pH 791 : between 3.0 and 5.0, in a solution containing 20 mg per mL.Loss on drying 731 — Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.Residue on ignition 281 : between 22.5% and 26.0%.Potassium— Acidify 5 mL of a solution (1 in 20) with 6 N acetic acid, and add 5 drops ofsodium cobaltinitrite TS: no precipitate is formed.Arsenic, Method II 211 : 3 µg per g.Heavy metals, Method II 231 : 0.001%.Content of sulfate— Transfer about 1 g of Glucosamine Sulfate Sodium Chlori de, accurately weighed, to a 250-mL beaker, and dissolve in about 100 mL of water. Add 4 mL of 6 N hydrochloric acid. Heat the solutionto boiling, and add, with constant stirring, sufficient boiling barium chloride T S to completely precipitate the sulfate.Add an additional 2 mL of barium chloride TS, and digest on a steam bath for 1 hour. Pass the mixturethrough ashless filter paper, transferring the residue quantitatively to the filter, and wash the residue withhot water until no precipitate is obtained when 1 mL of silver nitrate TS is add ed to 5 mL of washing.Transfer the paper containing the residue to a tared crucible. Char the paper, without burning, and ignitethe crucible and its contents to constant weight. Calculate the content of sulfat e by multiplying the weightobtained by 0.4116. The content of sulfate is between 16.3% and 17.3%. Assay—Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system— Proceed asdirected in the Assay under Glucosamine Hydrochloride.Assay preparation— Transfer about 100 mg of Glucosamine Sulfate Sodium Chloride, accurately weighed, to a 100-mL volumetric flask. Dissolve in 30 mL of water, shake by mechanical means, dilute with water to volume,and mix.Procedure— Proceed as directed in the Assay under Glucosamine Hydrochlor ide. Calculate thepercentage of (C6H14NO5)2SO4·2NaCl in the portion of Glucosamine Sulfate Sodium Chloride takenby the formula:10,000(573.31/431.26)(C / W)(rU / rS)in which 573.31 is the molecular weight of the glucosamine sulfate sodium chl oride and 431.26 istwice the molecular weight of glucosamine HCl; W is the weight, in mg, of Glu cosamine SulfateSodium Chloride used to prepare the Assay preparation; and the others terms are as defined therein.Auxiliary Information— Please check for your question in the FAQs before conUSP32–NF27 Page 1031Pharmacopeial Forum: Volume No. 33(4) Page 692Chromatographic Column—GLUCOSAMINE SULFATE SODIUM CHLORIDEChromatographic columns text is not derived from, and not part of, USP 32 or NF 27项目标准（美国药典版）性状白色结晶性粉末比旋度+52°—+54°pH值 3.00—4.50铁离子≤10PPM重金属≤10PPM干燥失重≤1.00%含量98.0%-102.0%（以干基计）灼烧残渣23.5—25.0%氯化物≤14.00%硫酸盐16.3%-17.3%有机挥发杂质符合要求微生物检验细菌总数酵母、霉菌沙门氏菌大肠杆菌不大于500/g 不大于100/g 不得检出不得检出包装和储存保存在密封闭光的容器内有效期两年。
盐酸氨基葡萄糖质量标准及检验操作规程
文件名称盐酸氨基葡萄糖质量标准及检验操作规程文件编号JS-SPE-YL-002版本号BS1.0 第 1 页共 7 页一、目的：规范辅料盐酸氨基葡萄糖的取样及检验操作程序，为盐酸氨基葡萄糖的采购、检验及贮存提供依据，建立评定盐酸氨基葡萄糖质量和批准放行的标准，确保物料的正常使用。
二、适用范围：适用于采购人员的采购依据，取样人员的取样依据，检验人员的检验依据，仓库保管人员的贮存依据，复核人的复核依据，质量部长的批准放行和监督的依据，QA监控的依据，盐酸氨基葡萄糖药材质量评价的依据。
三、责任者：采购人员按本规范项下规定的标准进行采购；取样人按本规范项下的取样方法执行取样操作及书写记录；检验人按本规范项下的检验方法执行检验操作及书写记录；复核人按本规范进行复核检查；质量部长按本规范进行监督和批准放行；QA按本规范对药材质量实施监控；仓库保管人员按本规范项下的贮存条件进行保管。
四、内容：1物料名称：中文名：盐酸氨基葡萄糖拼音名：Yiansuan Anjiputaotang 拉丁名：Glucosamine Hydrochloride2 物料代码：YL0073 标准依据：《中国药典》2010年版二部P12344 经批准的供应商：5 来源：本品为2-氨基-2-脱氧-D(+)-吡喃葡萄糖盐酸盐，按干燥品计算，含C6H14O3NCl应为98.0%~102%。
6 取样方法：6.1取样器具：不锈钢剪刀、不锈钢勺、75%乙醇、手套、自封袋、取样标签、留样标签6.2盐酸氨基葡萄糖属直接入药辅料，须按取样规则在洁净取样车或洁净取样间取样。
6.3用不锈钢剪刀将外包装打开，在洁净取样车或洁净取样间条件下，按2～3个不同部位各取盐酸氨基葡萄糖5～10g；每一包件取样量为25～50g，最终抽取量为200g。
20g用做微生物限度检查，其他180g取好的样品平均分成三份分别放入自封袋中，封口。
其中2份贴取样标签，用于检验和复验；1份贴留样标签，用于留样观察。
氨基葡萄糖硫酸软骨素USP标准
USP 35Dietary Supplements / Glucosamine1333Staining reagent for 5 min. Then stir the solution gently Ginseng, American—see American Ginsengfor 1 min. Remove the membrane, and destain in 5%acetic acid until the background clears.Acceptance criteria: The principal spot of the Samplesolution has the same migration as the principal spot ofthe Standard solution.[N OTE—Document the results by taking a picture within Ginseng, Asian—see Asian Ginseng15 min of completion of destaining.]STRENGTH•C ONTENT OF G LUCOSAMINEDiluent: Transfer 29 µL of acetic acid and 5 mL of aceto-nitrile to a 100-mL volumetric flask containing 50 mL ofwater. Dilute with water to volume.Ginseng, Siberian—see EleutheroBorate buffer: 0.2 M (76.3 g/L of sodium borate inwater) adjusted with hydrochloric acid TS to a pH of 9.5Acetate buffer: 6.80 g/L of sodium acetate trihydrate inwater adjusted with dilute acetic acid to a pH of 5.9Derivatizing reagent: In a 14-mL polypropylene culturetube, dissolve 50 mg of o-phthalaldehyde in 1.25 mL ofanhydrous methanol. Add 50 µL of 3-mercaptopropionic Sodium Tablets acid and 11.2 mL of Borate buffer, and mix gently. Allowto stand in the dark for 30 min before use. [N OTE—Rea-DEFINITION gent strength is maintained by adding 10 µL of 3-mer-Glucosamine and Chondroitin Sulfate Sodium Tablets are captopropionic acid every 2 days. Storage should be in prepared from either Glucosamine Hydrochloride, Gluco-the dark at room temperature, and can be used for NMT samine Sulfate Sodium Chloride, Glucosamine Sulfate Po- 2 weeks.]tassium Chloride, or a mixture of any of them, with Mobile phase: Methanol and Acetate buffer (1:9) Chondroitin Sulfate Sodium. Tablets contain NLT 90.0%Standard solution: 1.0 mg/mL of USP Glucosamine Hy-and NMT 120.0% of the labeled amounts of chondroitin drochloride RS in water. Allow to stand at room temper-sulfate sodium and glucosamine (C6H13NO5).ature for 1 h.[N OTE—Chondroitin Sulfate Sodium is extremely hygro-Sample solution: Transfer an equivalent to 25 mg of scopic once dried. Avoid exposure to atmosphere, and glucosamine, from finely powdered Tablets (NLT 20), to weigh promptly.] a 25-mL volumetric flask. Dilute with Diluent to volume.Mix on a vortex mixer to suspend the powder in solu-IDENTIFICATION tion. Sonicate in a 65° water bath for 20 min. Remove •A. The retention time of the major peaks of the Sample from the bath, stir for 5 min with the aid of a magnetic solution correspond to those of the Standard solution, as stirrer, and centrifuge.obtained in the test for Content of Glucosamine.Chromatographic system•B. E LECTROPHORESIS〈726〉 (See Chromatography 〈621〉, System Suitability.)Barium acetate buffer: Dissolve 25.24 g of barium ace-Mode: LCtate in 900 mL of water. Adjust with acetic acid to a pH Detector: UV 340 nmof 5.0, and dilute with water to 1000 mL.Column: 3.0-mm × 5-cm; packing L1Staining reagent: 0.1% (w/v) toluidine blue in 0.1 M Flow rate: 1 mL/minacetic acid Injection size: 10 µLStandard solution: Use the Standard solution of middle System suitabilityconcentration from the test for Content of Chondroitin Samples: Five individual aliquots of the Standard solu-Sulfate Sodium.tion derivatized as directed in the Analysis. Each deriva-Sample solution: Prepare as directed in the test for Con-tized aliquot is injected only once.tent of Chondroitin Sulfate Sodium.[N OTE—The relative retention times for the β-anomer Analysis: Fill the chambers of an electrophoresis appara-and the α-anomer are 1.0 and 1.8, respectively. The tus suitable for separations on cellulose acetate mem-retention time for the β-anomer is NLT 4 min.] branes1 (a small submarine gel chamber or one dedi-Suitability requirementscated to membrane media) with Barium acetate buffer.Relative standard deviation: NMT 2.0% from five Soak a cellulose acetate membrane 5–6 cm × 12–14 cm replicate injectionsin Barium acetate buffer for 10 min, or until evenly wet-Analysisted, then blot dry between two sheets of absorbent pa-Samples:Standard solution and Sample solutionper. Using an applicator2 suitable for electrophoresis, ap-Transfer 100 µL of the Derivatizing reagent and 100 µL of ply equal volumes (0.5 µL) of the Sample solution and the Standard solution or Sample solution to a vial con-Standard solution to the brighter side of the membrane taining 400 µL of Borate buffer. Allow the derivatization held in position in an appropriate applicator stand or on to proceed for 1 min. Inject the derivatized solutionsa separating bridge in the chamber. Ensure that both immediately after the derivatization reaction.ends of the membrane are dipped at least 0.5–1.0 cm Calculate the percentage of the labeled amount of glu-deep into the buffer chambers. Apply a constant 60 V (6cosamine (C6H13NO5) in the portion of Tablets taken: mA at the start) for 2 h. [N OTE—Perform the applicationof solutions and voltage within 5 min because further Result = (r U/r S) × (C S/C U) × (M r1/M r2) × 100 drying of the blotted paper reduces sensitivity.]Place the membrane in a plastic staining tray, and with r U= peak response of the β-anomer from the the application side down, float or gently immerse in derivatized Sample solutionr S= peak response of the β-anomer from the1Suitable cellulose acetate membranes for electrophoresis are available from derivatized Standard solutionMalta Chemetron SRL, Milano, Italy (); FlukaChemical Corp., Milwaukee, WI; and DiaSys Corp., Waterbury, CT C S= concentration of USP Glucosamine().Hydrochloride RS in the Standard solution2Suitable applicators are available from DiaSys Corp., Waterbury, CT(mg/mL)() and Helena Laboratories, Beaumont, TX().1334Glucosamine / Dietary Supplements USP 35C U= nominal concentration of glucosamine in the Calculate the percentage of the labeled amount ofSample solution (mg/mL)glucosamine (C6H13NO5) dissolved: M r1= molecular weight of glucosamine, 179.17Result = (r U/r S) × (C S×V/L) × (M r1/M r2) × 100 M r2= molecular weight of glucosaminehydrochloride, 215.63r U= peak area from the derivatized Sample solution Acceptance criteria: 90.0%–120.0%r S= peak area from the derivatized Standard•C ONTENT OF C HONDROITIN S ULFATE S ODIUMsolutionDiluent: Weigh about 297 mg of monobasic potassiumC S= concentration of USP Glucosaminephosphate, 492 mg of dibasic potassium phosphate, andHydrochloride RS in the Standard solution 250 mg of polysorbate 80, and transfer into a 1-L(mg/mL)beaker. Dissolve in approximately 900 mL of water, andV= volume of Medium, 900 mL adjust with potassium hydroxide or phosphoric acid to aL= label claim of glucosamine (mg/Tablet) pH of 7.0 ± 0.2. Dilute with water to 1 L, and mixM r1= molecular weight of glucosamine, 179.17 thoroughly.M r2= molecular weight of glucosamineStandard solutions: 1.5, 1.0, and 0.5 mg/mL of USPhydrochloride, 215.63 Chondroitin Sulfate Sodium RS in waterTolerances: NLT 75% of the labeled amount of Sample solution: Transfer an equivalent to 100 mg ofglucosamine (C6H13NO5) is dissolved.chondroitin sulfate sodium, from finely powdered TabletsDetermine the percentage of the labeled amount of (NLT 20), to 60 mL of water. Shake to suspend thechondroitin sulfate sodium dissolved by using the powder in solution. Sonicate in a 65° water bath for 20following method.min. Remove from the bath, and stir or shake for 5 min.Standard solutions, Titrant, and Diluent: Proceed as Dilute with water to 100 mL, and centrifuge or passdirected in the test for Content of Chondroitin Sulfate through a suitable filter.Sodium.Titrimetric systemSample solution: Use the solution under test.(See Titrimetry 〈541〉.)Analysis: Proceed as directed in the test for Content of Mode: Photometric titrationChondroitin Sulfate Sodium.Titrant: 1 mg/mL of cetylpyridinium chloride in water.Calculate the percentage of the labeled amount of Degas before use.chondroitin sulfate sodium dissolved: Endpoint detection: Turbidimetric with a photoelectricprobeResult = (C×V/L) × 100AnalysisSamples:Standard solutions and Sample solution C= determined concentration of chondroitin Transfer 5.0 mL of each Standard solution and the sulfate sodium in the Sample solutionSample solution to separate titration vessels. Add 25(mg/mL)mL of Diluent to each. Stir until a steady reading is V= volume of Medium, 900 mLobtained with a photoelectric probe either at 420,L= label claim of chondroitin sulfate sodium550, or 660 nm. Set the instrument to zero in(mg/Tablet)absorbance mode. Titrate with Titrant using the Tolerances: NLT 75% of the labeled amount ofphotoelectric probe to determine the endpoint chondroitin sulfate sodium is dissolved.turbidimetrically. From a linear regression equation•W EIGHT V ARIATION OF D IETARY S UPPLEMENTS〈2091〉: Meet calculated using the volumes of Titrant consumed the requirementsversus concentrations of the Standard solutions,determine the concentration of chondroitin sulfate ADDITIONAL REQUIREMENTSsodium in the Sample solution.•P ACKAGING AND S TORAGE: Preserve in tight, light-resistant Calculate the percentage of the labeled amount of containers.chondroitin sulfate sodium in the portion of Tablets•L ABELING: The label indicates the types of glucosamine taken:salts contained in the article and the species source fromwhich the chondroitin was derived. Label it to state the Result = (C/C U) × 100source(s) of chondroitin sulfate sodium, whether bovine,porcine, avian, or a mixture of any of them. The label C= determined concentration of chondroitin states on the front panel the content of chondroitinsulfate sodium in the Sample solution sulfate sodium on the dried basis.(mg/mL)•USP R EFERENCE S TANDARDS〈11〉C U= nominal concentration of chondroitin sulfate USP Chondroitin Sulfate Sodium RSsodium in the Sample solution (mg/mL)USP Glucosamine Hydrochloride RSAcceptance criteria: 90.0%–120.0%PERFORMANCE TESTS•D ISINTEGRATION AND D ISSOLUTION OF D IETARY S UPPLEMENTS〈2040〉: Meet the requirements for Dissolution Glucosamine HydrochlorideMedium: Water; 900 mLApparatus 2: 75 rpmTime: 60 minDetermine the percentage of the labeled amount ofglucosamine (C6H13NO5) dissolved by using thefollowing method.Standard solution: Prepare as directed in the test forContent of Glucosamine. Dilute with a suitable quantity ofwater, if necessary.C6H13NO5·HCl215.63 Sample solution: Use the solution under test.D-Glucose, 2-amino-2-deoxy-, hydrochloride;Borate buffer, Acetate buffer, Derivatizing reagent,2-Amino-2-deoxy-β-D-glucopyranose hydrochloride [66-84-Mobile phase, and Chromatographic system: Proceed2].as directed in the test for Content of Glucosamine.Analysis: Proceed as directed in the test for Content ofGlucosamine.。
盐酸氨基葡萄糖 欧洲药典标准
盐酸氨基葡萄糖欧洲药典标准
盐酸氨基葡萄糖是一种常用的药物，其欧洲药典标准如下：
1. 名称：盐酸氨基葡萄糖（Glucosamine Hydrochloride）
2. 分子式：C6H13NO5·HCl
3. 分子量：215.63
4. 外观：白色结晶性粉末
5. 溶解性：易溶于水，微溶于乙醇
6. 鉴别试验：
（1）红外光谱法：与对照品的红外吸收光谱图相符。
（2）氯化铵试验：样品在加入氯化铵后立即产生白色沉淀。
7. 含量测定：
采用高效液相色谱法（HPLC）进行含量测定。
样品在流动相中以260nm处检测。
结果应符合规定的标准。
8. 水分测定：
样品在105℃下干燥至恒重，得到的水分含量应不超过1.0%。
9. 重金属含量：
采用原子吸收光谱法进行重金属含量测定。
结果应符合规定的标准。
10. 细菌限度：
采用菌落计数法进行细菌限度测定。
结果应符合规定的标准。
以上就是盐酸氨基葡萄糖的欧洲药典标准，这些标准对于保证药品的质量和安全性具有重要意义，同时也为相关行业提供了技术支持和指导。
N-乙酰氨基葡萄糖-USP38
USP 38Dietary Supplements / N-Acetylglucosamine5865 Dietary SupplementsOfficial Monographs[N OTE—The relative retention times for N-acetyl-glucosamine and glucosamine are 1.0 and about 2.8, N-Acetylglucosaminerespectively.]Suitability requirementsSignal-to-noise ratio: NLT 10 for the glucosaminepeak, System suitability solutionResolution: NLT 5.0 between the N-acetyl-glucosamine and glucosamine peaks, System suitabil-ity solutionTailing factor: NMT 2.0, Standard solutionRelative standard deviation: NMT 2.0%, StandardsolutionC8H15NO6221.21Analysis2-(Acetylamino)-2-deoxy-D-glucose;Samples:Standard solution and Sample solutionN-Acetyl-D-Glucosamine [7512-17-6].Calculate the percentage of N-acetylglucosamine(C8H15NO6) in the portion of N-Acetylglucosamine DEFINITION taken:N-Acetylglucosamine contains NLT 98.0% and NMT 102.0%of N-acetylglucosamine (C8H15NO6), calculated on the Result = (rU/r S) × (C S/C U) × 100dried basis.r U= peak response from the Sample solution IDENTIFICATION rS= peak response from the Standard solution •A. I NFRARED A BSORPTION〈197K〉CS= concentration of USP N-Acetylglucosamine RS •B. It meets the requirements in the test for Optical Rota-in the Standard solution (mg/mL) tion 〈781S〉, Specific Rotation.CU= concentration of N-Acetylglucosamine in the •C. The retention time of the major peak of the Sample Sample solution (mg/mL) solution corresponds to that of the Standard solution, as Acceptance criteria: 98.0%–102.0% on the dried basis obtained in the Assay.IMPURITIESASSAY•R ESIDUE ON I GNITION〈281〉: NMT 0.1%•P ROCEDURE•C HLORIDE AND S ULFATE, Chloride〈221〉: NMT 0.1% Buffer: Transfer 3.5g of dibasic potassium phosphate to•E LEMENTAL I MPURITIES—P ROCEDURES〈233〉a 1-L volumetric flask, and add sufficient water to dis-Acceptance criteriasolve. Add 0.25mL of ammonium hydroxide, dilute Arsenic: NMT 1µg/gwith water to volume, and mix. Adjust with phosphoric Lead: NMT 10µg/gacid to a pH of 7.5.•R ELATED C OMPOUNDSMobile phase: Acetonitrile and Buffer (75:25)Buffer, Mobile phase, Diluent, System suitability solu-Diluent: Acetonitrile and water (50:50)tion, Chromatographic system, and System suitabil-System suitability solution: 1.0mg/mL of USP N-ity: Proceed as directed in the Assay.Acetylglucosamine RS and 0.6mg/mL of USP Glucosa-Sample solution: 2.5mg/mL of N-Acetylglucosamine in mine Hydrochloride RS in Diluent DiluentStandard solution: 1.0mg/mL of USP N-Acetyl-Analysisglucosamine RS in Diluent Sample:Sample solutionSample solution: 1.0mg/mL of N-Acetylglucosamine in Calculate the percentage of each impurity in the por-Diluent tion of N-Acetylglucosamine taken:Chromatographic system(See Chromatography 〈621〉, System Suitability.)Result = (rU/r T) × 100 Mode: LCDetector: UV 195 nm r U= peak response of each impurity from the Column: 4.6-mm × 15-cm; 3-µm packing L8Sample solutionColumn temperature: 35°r T= sum of the peak responses from the Sample Flow rate: 1.5mL/min solutionInjection volume: 10µLSystem suitabilitySamples:System suitability solution and Standardsolution5866N -Acetylglucosamine / Dietary SupplementsUSP 38Acceptance criteriaDEFINITIONIndividual impurity: NMT 0.5% N -Acetyltyrosine contains NLT 98.5% and NMT 101.0% of Total impurities: NMT 2.0%N -acetyltyrosine (C 11H 13NO 4), as N -acetyl-L -tyrosine, calcu-•L IMIT OF G LUCOSAMINElated on the dried basis.Buffer, Mobile phase, Diluent, System suitability solu-IDENTIFICATIONtion, Chromatographic system, and System suitabil-•A . I NFRARED A BSORPTION 〈197K 〉ity: Proceed as directed in the Assay .•B . O PTICAL R OTATION , Specific Rotation 〈781S 〉Standard solution: 0.6mg/mL of USP Glucosamine Hy-Sample solution: 10mg/mLdrochloride RS in DiluentAcceptance criteria: NLT +46.0° and NMT +49.0°, de-Sample solution: 50mg/mL of N -Acetylglucosamine in termined at 20°Diluent •C . The R F value of the principal spot of the Sample solu-Analysistion in the test for Organic Impurities corresponds to that Samples: Standard solution and Sample solutionof Standard solution 1.Calculate the percentage of glucosamine in the portion of N -Acetylglucosamine taken:ASSAY•P ROCEDUREResult = (r U /r S ) × (C S /C U ) × (M 1/M 2) × 100Sample solution: Dissolve about 180mg of N -Acetyltyrosine, weighed, in 50mL of carbon dioxide-r U= peak response of glucosamine from thefree water.Sample solutionTitrimetric system r S = peak response of glucosamine from the(See Titrimetry 〈541〉.)Standard solutionMode: Direct titrationC S = concentration of USP GlucosamineTitrant: 0.1 N sodium hydroxide VS Hydrochloride RS in the Standard solution Endpoint detection: Potentiometric(mg/mL)Equivalency: Each mL of 0.1 N sodium hydroxide VS C U = concentration of N -Acetylglucosamine in theis equivalent to 22.32mg of N -acetyltyrosine Sample solution (mg/mL)(C 11H 13NO 4).M 1= molecular weight of glucosamine, 179.17M 2= molecular weight of glucosamineIMPURITIEShydrochloride, 215.63•R ESIDUE ON I GNITION 〈281〉: NMT 0.1%Acceptance criteria: NMT 1.0%•C HLORIDE AND S ULFATE , Chloride 〈221〉Sample: 0.7gSPECIFIC TESTSStandard: 0.40mL of 0.01 N hydrochloric acid •O PTICAL R OTATION , Specific Rotation 〈781S 〉Acceptance criteria: NMT 200ppm Sample solution: 20mg/mL in water, perform the •C HLORIDE AND S ULFATE , Sulfate 〈221〉measurement 3 h after sample preparation.Sample: 1.2gAcceptance criteria: +39.0° to +43.0°Standard: 0.25mL of 0.020 N sulfuric acid •P H 〈791〉Acceptance criteria: NMT 200ppm Sample solution: 10mg/mL in water •I RON 〈241〉: NMT 20ppmAcceptance criteria: 6.0–8.0•L OSS ON D RYING 〈731〉Analysis: Dry a sample at 105° for 2 h.Delete the following:Acceptance criteria: NMT 0.5%•M ELTING R ANGE OR T EMPERATURE 〈741〉: 196°–205°••H EAVY M ETALS , Method 1 〈231〉: NMT 10ppm •(Official 1-•M ICROBIAL E NUMERATION T ESTS 〈2021〉: The total aerobic Dec-2015)bacterial count does not exceed 103 cfu/g; the total com-•O RGANIC I MPURITIESbined molds and yeasts count does not exceed 103 cfu/Adsorbent: 0.25-mm layer of chromatographic silica g.gel mixture•A BSENCE OF S PECIFIED M ICROORGANISMS 〈2022〉: Meets the Standard stock solution 1: 8mg/mL of USP N -Acetyl-L -requirements of the tests for absence of Salmonella spe-tyrosine RS in a mixture of water, glacial acetic acid,cies and Escherichia coliand alcohol (3:3:94)Standard solution 1: Dilute Standard stock solution 1ADDITIONAL REQUIREMENTSwith alcohol to obtain a solution having a known con-•P ACKAGING AND S TORAGE : Preserve in tight, light-resistant centration of about 0.4mg/mL.containers.Standard solution 2: 0.8mg/mL of USP L -Tyrosine RS •USP R EFERENCE S TANDARDS 〈11〉dissolved in a mixture of glacial acetic acid and water USP N -Acetylglucosamine RS(1:1), and diluted with alcoholUSP Glucosamine Hydrochloride RSSample solution: Transfer 0.8g of N -Acetyltyrosine to a 10-mL volumetric flask, dissolve in 6mL of a mixture of glacial acetic acid and water (1:1), and dilute with alco-hol to volume.Application volume: 5µLN -AcetyltyrosineDeveloping solvent system: A mixture of ammonia and 2-propanol (3:7)Spray reagent: Dissolve 0.2g of ninhydrin in 100mL of a mixture of butanol and 2N acetic acid (95:5).Analysis: Proceed as directed for Chromatography 〈621〉,Thin-Layer Chromatography. After air-drying the plate,repeat the development process. After air-drying a sec-ond time, examine the plate under short-wave UV light,C 11H 13NO 4223.2and record principal and secondary spots. Spray the N -Acetyl-L -tyrosine;plate with Spray reagent , and heat between 100° and (2S )-2-(Acetylamino)-3-(4-hydroxyphenyl)propanoic acid)105° for about 15 min. Examine the plate under white [537-55-3].light, and record the principal and secondary spots.。
盐酸氨基葡萄糖胶囊说明书
盐酸氨基葡萄糖胶囊说明书盐酸氨基葡萄糖胶囊(普力得)用于缓解和预防骨关节炎的关节(膝、髋、脊柱、肩、手腕、踝等)软骨磨损、退化所致的疼痛、僵硬、肿胀和活动困难。
下面是店铺整理的盐酸氨基葡萄糖胶囊说明书，欢迎阅读。
盐酸氨基葡萄糖胶囊商品介绍通用名：盐酸氨基葡萄糖胶囊生产厂家: 北京康必得药业有限公司批准文号：国药准字H20070173药品规格：42粒药品价格：￥298元盐酸氨基葡萄糖胶囊说明书【通用名称】盐酸氨基葡萄糖胶囊【商品名称】盐酸氨基葡萄糖胶囊(普力得)【英文名称】GlucosamineHydrochlorideCapsules【拼音全码】YanSuanAnJiPuTaoTangJiaoNang(PuLiDe)【主要成份】盐酸氨基葡萄糖，辅料为明胶胶囊壳。
化学名：2-氨基-2-脱氧-D-(+)-吡喃葡萄糖盐酸盐分子式：C6H13NO5HCl分子量：215.63【性状】盐酸氨基葡萄糖胶囊(普力得)为胶囊剂，内容物为白色或类白色粉末。
【适应症/功能主治】用于缓解和预防骨关节炎的关节(膝、髋、脊柱、肩、手腕、踝等)软骨磨损、退化所致的疼痛、僵硬、肿胀和活动困难。
【规格型号】0.24g*180s+42s【用法用量】口服，一次1～2粒，一日3次，一般疗程4～12周。
【不良反应】罕见轻度的胃肠不适、如恶心、便秘、腹胀和腹泻;皮肤红斑、皮疹、瘙痒。
【禁忌】对盐酸氨基葡萄糖胶囊(普力得)过敏者禁用。
【注意事项】1.盐酸氨基葡萄糖胶囊(普力得)宜在饭时或饭后服用，可减少胃肠道不适，特别是有胃溃疡的患者。
2.严重肝、肾功能不全者慎用。
3.用药一疗程后，症状未缓解，请咨询医师或药师。
4.孕妇和哺乳期妇女慎用。
5.对盐酸氨基葡萄糖胶囊(普力得)过敏者禁用，过敏体质者慎用。
6.盐酸氨基葡萄糖胶囊(普力得)性状发生改变时禁止使用。
7.请将盐酸氨基葡萄糖胶囊(普力得)放在儿童不能接触的地方。
8.如正在使用其他药品，使用盐酸氨基葡萄糖胶囊(普力得)前请咨询医师或药师。
氨基葡萄糖盐酸盐HPLC含量检测方法(USP40)中文
氨基葡萄糖盐酸盐HPLC含量检测方法(USP40)
含量测定
●过程
缓冲液：在1-L容量瓶中溶解3.5克磷酸二氢钾在水中。
加入0.25毫升氢氧化铵，用水稀释至体积，混合。
用磷酸调节pH值为7.5
流动相：乙腈和缓冲区（75∶25）
稀释剂：乙腈和水（50∶50）
标准溶液：3.8毫克/毫升USP氨基葡萄糖盐酸盐标准品稀释剂
样品溶液：3.8毫克/毫升氨基葡萄糖盐酸盐稀释剂（注意：用机械方法摇匀以帮助溶解）
●色谱系统
（参考色谱法<621>，系统适应性）
模式：LC
检测器：UV 195nm
色谱柱： 4.6-mm × 15-cm，5-µm填充 L8
柱温：35℃
流速：1.5ml/min
进样量; 10 µL
●系统适应性
样品：标准溶液（氨基葡萄糖部分的峰值在约10分钟，由于氯离子的存在色谱图上在孔隙体积附近会出现一个较大的附加峰）
适应性要求
拖尾因子：氨基葡萄糖峰不超过2.0
理论塔板数≥1500
相对标准偏差：≤2.0%
●检测：
样品：标准溶液和样品溶液氨基葡萄糖(C 6 H 13 NO 5 · HCl)含量的计算
结果=(r
U /r
S
) × (C
S
/C
U
) × 100
r
U
=样品溶液的峰面积
r
S
=标准溶液的峰面积
C
S
=氨基葡萄糖盐酸盐标准溶液的浓度
C
U
=氨基葡萄糖盐酸盐样品溶液的浓度接受标准：98.0%-102%（以干计）。
氨基葡萄糖盐酸盐标准
食品添加剂氨基葡萄糖盐酸盐3结构式、分子式和相对分子量结构式：分子式：相对分子量：4要求性状产品为白色或类白色结晶粉末。
理化指标应符合表1的规定。
表1 微生物指标应符合表2的规定。
表25试验方法除非另有说明，在分析中仅使用确认为分析纯的试剂和GB/T6682中规定的水。
感官将样品置于清洁、干燥的白瓷盘中，在自然光线下，观察其色泽和状态。
氨基葡萄糖盐酸盐（）含量仪器设备液相色谱仪；氨基柱×25cm，5μm)；μL定量环；电子分析天平(万分之一)。
分析要求鉴别：在含量测定项下记录色谱图，对照品溶液的主峰保留时间与样品溶液的主峰保留时间应一致；系统适应性：拖尾因子≤2，理论塔板数≥1500，RSD≤2%。
色谱条件流速：min；色谱柱温度：35℃；检测器：紫外检测器；检测器波长：195nm；进样量：10μL；运行时间：20分钟；溶液制备流动相溶液制备流动相A：乙腈；流动相B：称取磷酸氢二钾，加入的氨水，用水定容至1L，混匀，用磷酸调节PH至；流动相A：流动相B=75:25。
蒸馏水和所用试剂均使用色谱级，流动相要用μm的有机相滤膜过滤后并超声15分钟，待用。
稀释液的配制乙腈:水=50:50，蒸馏水和乙腈均使用色谱级，流动相要用μm的有机相滤膜过滤后并超声15分钟，待用。
对照品液精确称取对照品三份(精确至置于100mL容量瓶中，用稀释液溶解并定容至刻度，摇匀待用。
供试品液精确称取烘干的供试品两份(精确至置于100mL容量瓶中，用稀释液溶解并定容至刻度，摇匀待用。
样品与对照品溶液需要通过μm有机相滤头过滤后进样。
操作步骤系统适应性按液相色谱仪检验操作规程，开启仪器并使仪器达到稳定状态后,用相同体积的进样针将三个对照品溶液按顺序依次注入色谱（定量环10μL），每个对照品分别进两针，共计六针，分别计算校正因子f1……f6，利用校正因子按下式计算得：RSD≤2%。
相对标准偏差计算公式：式中：RSD——相对标准偏差；f i——第i针工作对照品的校正因子,是相应工作对照品的重量与面积的比值；f——工作对照品的平均校正因子；n——连续取了n针工作对照品校正因子。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
盐酸氨基葡萄糖
质量标准
C6H13NO5·HCl，化学名D-葡萄糖-2-氨基-2-脱氧-盐酸盐，2-氨基-2脱氧-β-D-吡喃葡萄糖盐酸盐。
以干燥品计算，含盐酸氨基葡萄糖的量应为标示量的98.0%~102.0%。
包装和贮存：应密封避光贮存。
【鉴别】A. 本品的红外光吸收图谱应与硫酸软骨素钠对照品的图谱一致.
B. 显氯化物的鉴别反应。
C. 在含量测定项下记录的色谱图中，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。
【比旋度】取本品，精密称定，用水溶解并定量稀释制成每1ml中约含25mg的溶液。
放置3小时后测定，比旋度应为+70°至+73°。
【pH】取本品，精密称定，用水溶解并定量稀释制成每1ml中约含20mg的溶液，pH值为3.0~5.0.
【干燥失重】取本品，在105℃干燥2小时，减失重量不得过1.0%。
【炽灼残渣】不得过0.1%。
【硫酸盐】取本品0.1g，溶解，与0.25ml 硫酸（浓度0.010mol/L）对照液比较，不得更深（0.24%）。
【砷盐】不得过3μg/g。
【重金属】不得过0.001%。
【含量】
磷酸盐缓冲液：量取1ml磷酸与2L水混合，并加入适量氢氧化钠调节pH至3.0。
流动相：磷酸盐缓冲液-乙腈溶液（3:2）。
超声15min后，并用0.5μm孔径的微孔滤膜过滤。
标准溶液：精密称定盐酸氨基葡萄糖标准品，制备浓度为1.0mg/ml的盐酸氨基葡萄糖对照品水溶液。
供试品溶液：精密称取100mg盐酸氨基葡萄糖至100ml容量瓶中，先加30ml水并采用机械式震动使之充分溶解，继续加水至刻度定容，摇匀。
色谱条件：
检测波长：195nm
色谱柱：C8柱（全多孔硅胶微粒键合C8官能团固定相）：4.6mm×25cm
流速：0.6ml/min
按照程序进行检测并记录图谱：氨基葡萄糖主峰拖尾因子不得大于2.0；平行进样测定结果之间的RSD%不得大于2.0%。
程序：标准溶液、供试品溶液分别进样10μl，分别记录色谱图和氨基葡萄糖主峰面积。
按照以下计算公式算出盐酸氨基葡萄糖的含量：
10000(c/w)(r u/r s)
C——代表标准溶液中盐酸氨基葡萄糖的浓度，mg/ml
W——代表供试品的质量，mg
r u——代表供试品中氨基葡萄糖的峰面积
r s——代表标准溶液中氨基葡萄糖的峰面积。