908737 - Post Closing in Material Ledger CKMLCP 基本业务逻辑
UL8750最新英文版

UL 8750Light Emitting Diode (LED) Equipment for Use in Lighting ProductsMA Y 22, 2014 − UL 8750tr1UL Standard for Safety for Light Emitting Diode (LED) Equipment for Use in Lighting Products, UL 8750UL标准安全发光二极管(LED)设备用于照明产品、UL 8750First Edition, Dated November 18, 2009第一个版本,日期为2009年11月18日Summary of Topics 总结的主题This revision to ANSI/UL 8750 includes the following changes in requirements:这个修订ANSI / UL 8750变化包括以下要求:●Clarify requirements for conformal coatings, paragraph 7.7.27.7.2澄清要求保形涂料、段落●Insulation materials in transformers and coils ± Delete paragraph 7.11.2.11 and add Section 7.11.3绝缘材料在变形金刚和线圈±删除段落7.11.2.11 7.11.3并添加部分●Revise Risk of Fire De®nition to include 15 W power limit and revisions to Class 2 and LVLE referencesthroughout the standard修改火的风险包括15 W功率极限和修正二班和LVLE引用标准●Add requirements for supply and load connections添加需求供应和负载连接●Revisions to consolidate electrical spacings in Sections 7.7 and 7.8 and add optional shorting test forclosely-spaced PWB traces修订整合电气间距在章节7.7和7.8和添加可选做空测试间隔太近PWB痕迹●Add requirement for LED array (module) thermal measurement point添加要求LED阵列(模块)热计量点●Add temperature measurement method for polymeric materials when TC is optically radiated添加温度测量方法,当TC光学辐射高分子材料Text that has been changed in any manner or impacted by UL's electronic publishing system is marked with a vertical line in the margin. Changes in requirements are marked with a vertical line in the margin and are followed by an effective date note indicating the date of publication or the date on which the changed requirement becomes effective.文本已经以任何方式改变或影响UL电子出版系统的边缘有一条垂直线。
造纸专业常用英文缩略语

造纸专业常用英文缩略语AAA = atomic absorption原子吸收ABS = acrylonitrile-buladrene styrene丙烯腈—丁;烯—苯乙烯ACAR = angular correlation of annihilation radiation消除辐射的角相关性AM = acrylamide丙烯酰胺AOX = adsorbable organic halides可吸附的有机卤化物AP = plkali pulp碱法纸浆APAM = anionic polyacrylamide阴离子型聚丙烯酰胺ASB = aerotion stabilization basin稳定曝气池AST = activated sludge treatment活性污泥处理BBCT = best convential pollutant cotrol technology最常用污染物控制技术BDMT = bone dry metric tons绝干公吨BME = bipolar membrane electro dialysis两极膜电透析BMP = best management practices最优管理实践BOD = biochemical oxygen demand生化耗氧量BP = boiling point沸点BPK = bleached papergrade kraft and soda(生产)白纸用硫酸盐和荷性纳法浆BPT = best practicable control technology最佳实用控制技术BTU = british thermal unit英热单位BW = basis weight定量CCAD = computer aided design计算机辅助设计CBLI = chemistry-based leak indicator化学(法)示漏器CC = consistency controller浓度调节器CFD = computational fluid dynamics计算流体动力学CI = colour index比色指数= cofidence interval置信区间CL = colored ledger彩色底板CLSM = confocal laser scanning microscopy共焦激光扫描显微镜CMC = carboxy methylated cellulose羧甲基纤维素COMS = compliance optimization modeling system寻优模型系统CP = chemical pulp化学浆= chemical pure化学纯CPPC = coordinated phosphate/pH chemistry controller配位磷酸盐/pH 调节器CR = consistency regulator浓度调节器CRP = chloride removal process氯化物排出法CSD = condensate steam distillation column冷凝汽馏塔CTMP = chemical treatment in terms of sulphonation硫化期间的化学处理= chemithermomechanical pulp化学热磨机械浆CTU = centigrade thermal unit公制热量单位CV = coefficient variation偏离系数= crystal violet结晶紫DD = dioxide二氧化物DAF = dissolved air floatation(溶)气浮DCS = dissolved and colloidal substances溶解与胶态物= distributed control system集散控制系统DELS = Doppler electrophoretic light scattering多普勒电泳光扫描DIP = deinked pulp脱墨纸浆DKP = deinked kraft pulp脱墨牛皮纸浆DLK = double-line clippings双线限位DMS = dynamic mechanical spectroscopy动力谱学DMSO = dimethyl sulfoxide二甲亚砜DMT = dimethyl terephthalate对邻苯二甲酸二甲酯DO = dissolved oxygen溶解氧DP = degree of polymerization聚合度DSC = differential scanning calorimetry微分扫描量热法DVC = digital valve controller数字伐控制器EEC = embedded costs插入成本ECF = elemental chlorine free无元素氯(漂白)EDTA = ethylene eiamine tetraacetic acid乙二胺四乙酸EPC = experimental prismatic calcite实验棱镜方解石ERV = estimated replacement value预计取代值ESP = electrostatic precipitator静电滤尘器= emergency shutdown procedure事故停机程序EVA = ethylene vinyl acetate乙烯乙酸乙烯酯ESPRA = empire state paper research associates国立造纸研究会EVOH = ethylene-vinyl alcohol乙烯-乙烯醇FFAS = formamidine sulfinic acid甲脒亚磺酸FBB = folding box board折叠箱纸板FBK = fully bleached kraft全漂牛皮纸FC = flow controller流量控制器FID = free induction decays自由感应衰减FP = freezing point冰点;凝固点GGDP = gross domestic product本国生产总值GEMS = general energy and materials balance system通用能量和物料平衡系统GLC = gas-liquid chromatography气液色谱GPC = gel permeation chromatographic analysis凝胶渗透色谱分析GPM = gallons per minute加仑/分钟HHC = high consistency高浓HCR = high consistency refiner高浓磨浆机HD = high density高密度HPR = high production rate高生产率HPSEC = high-performance size-exclusion chromatography高性能粒度筛析色谱法HRT = hydraulic retention time水力停留时间HTH = high test hypochlorite高级漂粉HV = high voltage高压HW = hardwood硬木IIMPM = interactive multiplanar model相互作用的多面模型IPST = institute of paper science and technology造纸科技研究院IWC = international water consultants国际水质顾问团JJIT = just-in-time正好;准时KKP = kraft pulp牛皮浆;硫酸盐浆LLC = level controller液面控制器LCC = lignin-carbohydrate complexes木素-碳水化合物复合体LCL = lower control limits控制下限LCR = level cotroller and recorder液面控制记录仪LDPE = low density poly ethylene低密度聚乙烯LDV = laser Doppler velocimetry激光多普勒测速法LIVG = low inlet velocity gasification process低入口速度气化工艺LPR = low production rate低生产率LRD = long rang dependence广范围相关LVDT = linear position transducer线性位移变送器LWC = lightweight coated低定量涂布的MMACT = maximum achievable control technology最大可达控制技术MAP = modified atmosphere packaging改良常压包装法MC = marginal cost边际成本= medium consistency中浓(度)MDI = methylendiphenyl diisocyanate亚甲苯二苯二异氰酸酯MeB = methylene blue亚甲基兰,四甲基兰MEK = methyl ethyl ketone甲(基)乙(基)酮MF = machine finished机械整饰的MG = machine glazed机械上光的= malachte green孔雀绿MISS = mixed liquor suspended solids (有机物与活性污泥 )混合液中悬浮固体MOW = mixed office waste混合办公废纸MRP = matal removal process金属(离子)脱除过程MSW = municipal solid waste城市固体废物MVP = moisture vapor permeability水蒸汽渗透性MWL = milled wood lignin磨木木素NNC = nitrocellulose 硝化纤维素NF = nanofiltration超滤 (毫微过滤)NMR = nuclear magnetic resonance核磁共振NSPS = new source performance standards新的资源性能标准NSSC = neutral sulfite semi-chemical pulp中性亚硫酸半化学浆OOCC = old corrugated container旧瓦楞纸箱OD = over dry绝干;烘干OEE = overall equipment efficiency总设备效率OIT = oxidative induction temperature氧化起始温度O&M = operating and maintenance 使用与维护ONP = old newspaper旧新闻纸OPP = oriented polypropylene取向聚丙烯OPR = oil penetration rates渗油率OWL = oxidized white liquor氧化白液PPAL = positron annihilation life time正电子湮没寿命PC = pressure controller压力调节器PCA = principal components analysis主成分分析PCC = precipitated calcium carbonate沉淀碳酸钙PCR = pressure controller and recorder压力调节记录仪PDSC = pressure differential scanning colorimetry压差扫描量热术PEMS = predictive emissions modeling system预测排放模型系统PEO = poly ethylene oxide聚氧化乙烯PGS = papergrade sulfite造纸用硫磺PGW = pressurized groundwood压力磨木浆PM = paper machine 造纸机;抄纸机PM/ECCM = preventive maintenance and essential care and condition monitoring预防维修/基本维修及状态监测PP = polypropylene聚丙烯PSES = pretreatment standards for existing sources现存资源预测标准PSM = process safety management(生产)过程安全管理PTFE = polytetrafluoroethylene聚四氟乙烯PTR = photothermal radiometry光热辐射分析法PVC = polyvinylchloride聚氯乙烯PVDC = polyvinyl dichloride聚二氯乙烯PVSK = polyvinylsulfate聚乙烯硫酸酯RRDH = rapid displacement heating快速置换加热法RH = relative humidity相对湿度RMP = refiner mechanical pulp木片磨木浆;盘磨机械浆RN = regular number纸板标准号RT = radiographic testing射线照相试验,X射线检验SSBK = solid bleached kraft(同质)漂白牛皮纸SBR = sequencing batch reactors程序化间歇反应器SC = super calendered超级压光的SDI = silt density index淤泥浓度指数SE = supplemental energy补充能量;辅助能SEC = size exclusion chromatographic粒度筛析色谱法SEM = scanning electron microscope扫描电子显微镜SEM-EDS = scanning electron microscope-energy dispersive spectrometry扫描电子显微镜—能量分散能谱测定法SGW = stone ground wood磨石磨木浆SIF = stress intensity factor应力强度系数;应力强化因子SOPs = standard operating procedures标准作业程序SP = sulphite pulp亚硫酸盐纸浆SPC = satislical process control过程控制SRT = solids retention time粒子留着时间SUB = solid unbleached board(同质)本色浆纸板SW = softwood软木;针叶树SWL = sulphite waste liguor亚硫酸盐废液TTAC = totally applied chlorine总用氯量TC = temperature controller温度调节器TCDF = tetrachlorodibenzofuran四氯二苯并呋喃TCF = totally chlorine-free全无氯(漂白)TCR = temperature controller and recorder温度调节记录仪TGA = thermal gravimetric analysis热重分析TLA = thin layer activation薄层活性化TMP = thermo mechanical pulp热磨机械浆TP = thermo-plastic热塑性的TQ = threshold quantity临界量(值)TRS = total reduced sulfur总还原硫TS = tensile strength抗张强度TSS = total suspended solids总悬浮固体量UUBB = unbeached board本色(浆)纸板UBK = unbeached kraft本色牛皮纸UCL = upper control limits控制上限UT = ultrasonic testing超声试验UV = ultraviolet紫外光VVOC = volatile organic compound挥发性有机化合物WWAS = waste-activated sludge废活性污泥WFMT = wet fluorescent magnetic particle test湿荧光磁粉试验WL = white ledger白色帐簿纸WLC = white-lined chipboard白浆衬里的粗纸板WP = wood pulp木浆WVTR = water vapor transmission rate水蒸汽传递速度YYI = yellow index返黄值;返黄指数YP = yield point屈服(软化)点。
Diodes Inc. Material Data Sheet.pdf_1693271463.264

Diodes Inc. Material Data SheetRev: Aug 2011Part Number:B0530W-7-F, B0540W-7-F, B0520LW-7-F Weight (mg):10.655Element Material Group Materials CAS (ifapplicable)Average mass homogeneous Materal(%)Percent ofwhole (%)Mass (mg)ppmHomogeneous Materialppm overallDie,SchottkyDoped siliconDoped silicon *7440-21-3100.00% 3.4470.367100000034469 Fe 7439-89-657.65%576500162062 Ni 7440-02-041.00%410000115256 Mn7439-96-50.60%60001687Cr(not Cr 6+)7440-47-30.10%1000281 Co 7440-48-40.50%50001406 Si 7440-21-30.15%1500422Pure silver Ag 7440-22-4100.00%0.853 0.091 10000008530 Bonding wire1.4milAu 7440-57-5100.00%0.512 0.055 10000005122SiO260676-86-069.00%690000 441884 Epoxy Resin 29690-82-214.00%140000 89658 Phenol Resin 9003-35-47.00%70000 44829Mg(OH)21309-42-88.00%80000 51233 C 1333-86-40.20%2000 1281 others ---- 1.80%18000 11527 Ag7440-22-480.00%8000008256Bisphenol F28064-14-415.00%1500001548Glycidyl neodeconate26761-45-5 5.00%50000516Tin solder Pure Tin Sn7440-31-5100.00%2.003 0.213 100000020035 100.0010.6551000000Tolerance±10%Antimony compounds Organic tin compoundsAsbestos Ozone Depleting Substances - Class I (CFCs, HBFCs, etc.)Azo compoundsOzone Depleting Substances - Class II (HCFCs)Cadmium and cadmium compounds Perfluorooctane Sulphonate (PFOS) or related compoundsCertain Shortchain Chlorinated Paraffins Polybrominated biphenyls (PBB) and Polybrominated diphenyl ethers (PBDE) including D ecaBDE Chlorinated organic compounds Polychlorinated Biphenyls (PCBs)HalogensPolychlorinated Naphthalenes ( > 3 chlorine atoms)Hexavalent chromium compounds Radioactive SubstancesLead and lead compounds Tributyl Tin (TBT) and Triphenyl Tin (TPT)Mercury and mercury compoundsTributyl Tin Oxide (TBTO)* The Silicon Chip is doped at atomic levels with trace amounts of elements that may include Phosphorus, Boron, Arsenic, and other elements. Metalization mayinclude Titanium, Nickel, Aluminum, Silver or Gold These substances are not reported where their concentration is less than the minimum reportable level per the guidelines specified in the Tables of EIA JIG-101, Material Composition Declaration for Electronic Products.This product or product family does not contain any of the following substances except as CURRENTLY exempted by ELV II and RoHS and reported above:This product or product family does not contain any chemicals designated by the European Chemicals Agency (ECHA) as Substances of Very High Concern (SVHCs) underREACH. Please check the document at /_files/products_lead_free/RoHS_Product_List.pdf for the current compliance status.This data is based on information provided by our suppliers. We believe it to be correct but do not routinely validate it by measurement. It is for guidance only andDiodes Inc. does not guarantee its absolute accuracy or completenessAlloy 42Molding compound KTMC-1050GDie attached epoxy9005SP SOD-123 leadframe1.032 0.110 28.1112.99564.041 6.824。
进出口专业英语词汇(P1)

进出口专业英语词汇(P1)进出口专业英语词汇(P1)进出口专业英语词汇(P1)p-amine acetanilide 对氨基乙铣苯胺p-aminoazobenzene hydrochloride 对氨基偶氮苯盐酸盐p-aminophenol 对氨基苯酚p-anisidine 对氨基苯甲醚p-benzoquinone 对苯醌p-fluoro aniline 对氟苯胺p-hydroxy phenyl ethyl ketone 对羟基苯乙酮p-leuconiline 副品红隐色基p-n diode laser pn结二极管激光器p-n junction electroluminescent diode pn结电致发光二极管p-n junction laser pn结激光器p-n junction photodiode pn结光电二极管p-n junction semiconductor laser pn结半导体激光器p-nitroaniline 对硝基苯胺p-type semiconductor p型半导体paar calorimeter 帕尔量热器paar turbidimeter 帕尔浊度计paarlan 异乐灵pabnapar 帕布纳帕小花纹细布pace 节奏牌手表pacemaker analyser 起搏器分析器pacemaker pulse monitor 起搏器脉冲监视器pacemaker 起搏器pachas 帕查斯马海毛呢pachimeter 弹性切力极限测定计pachometer 测厚计pachras 帕克勒斯彩条粗布pachyma cocos 茯苓pachyma compound digestive tonic pill 保和丸pachymeter 测厚计pachyrhizua angulatus 粉葛pacific converter 丝束直接成条机pacific lamprey 太平洋鳗鱼pacific mackerel 太平洋鲐pacific yellowfin tuna 黄鳍金枪鱼pacific 太平洋牌手表pack cloth 打包布pack duck 打包帆布pack dyed yarn 筒子染色纱pack heating furnace 叠板加热炉pack mill 叠板轧机pack rope 打包绳pack sack 旅行背包pack take-off device 卸垛机pack thread 细绳pack tilting device 叠板翻转机pack twine 包扎麻绳pack-sack diamond drill 可背运的轻便金刚石钻机package counter 包装计数器package dryer 筒子烘燥机package linen 亚麻包装布package mill 打包用带钢轧机package tray 整装式塔盘package type air cooler 便携式空气冷却器package-drying machine 筒子纱干燥机packaged air conditioner 组合式空调器packaged boiler 移动式锅炉packaged gas turbine 快装式燃气轮机packaged reactor 装配式反应堆packaged rotary drum dryer 小型转筒式干燥机packaged tea 小包装茶packaged transistor 密封式晶体管packager 包装机packaging container of metal 金属包装容器packaging machine 包装机packaging paper 包装纸packaging production line 包装生产线packbasket 背篓packed column 填料塔packed-bed scrubber 填充床洗涤器packed-lantern-ring exchanger 填料-灯笼-环换热器packer 包装机packet adapter 分组适配器packet handler 分组处理器packet instamatic camera 袖珍型即拍即现照相机packet multiplexer 分组多路复用器packet repeater 分组中继器packet transmission controller 分组传输控制器packet voice and data multiplexer 分组话音与数据多路复用器packet voice multiplexer 分组话音多路复用器packing cloth 打包麻布packing machine 包装机packing machinery 包装机械packing maker 密封接合器packing material 包装材料packing needle 打包针packing paper 包装纸packing press 包装机packing ring 填料环packing rope 包装绳packing sheet 包装布packing tool 打包机packing washer 密封垫圈packless valve 无填料阀packplane 货舱可更换的飞机packsheet 高级打包麻布paco wool 羊驼毛pacputan wool 帕克普坦粗羊毛pacteron 帕克特龙铁碳磷母合金pad and cover for metal ironing board 金属熨衣板垫和套pad bearing 衬垫轴承pad dyer 轧染机pad lubricator 垫式润滑器pad printing machine 自动移印机pad quilted in diamond stitching 菱形绗褥pad quilted in zigzag stitching 之字绗褥pad relay 衰减器继电器pad with tape bindings 狭带捆边褥pad 拍纸簿padan 巴丹padauk furniture 红木家具padded back lining 黑背印花里子布padded jacket 夹袄padded shoulder 垫肩padder 垫整电容器padding capacitor 垫整电容器padding cloth 衬布padding condenser 垫整电容器padding machine 打底机padding mangle 轧染机padding 垫料paddings 西装麻衬布paddle agitator 桨式搅拌器paddle badminton 板羽球paddle blade stirrer 桨式搅拌器paddle blade type mixer 叶轮式混合机paddle board 蹼板paddle boat 明轮船paddle climb 攀架paddle drum bleacher 桨鼓漂白机paddle dryer 桨式干燥机paddle dyeing machine 桨叶式染色机paddle engine 明轮发动机paddle fan 离心式通风机paddle feeder 叶片式给料器paddle level switch 扳钮开关paddle loader 桨叶式装载机paddle mixer 叶片式搅拌机paddle passenger steamer 明轮客轮paddle steamer 明轮船paddle stirrer 桨式搅拌机paddle wheel agitator 叶轮式搅拌机paddle wheel elevator 叶轮式提升机paddle wheel water supplier 脚踏水车paddle wheel 桨轮paddle wool washing machine 桨叶式洗毛机paddle 乒乓球拍paddle-box 明轮壳paddle-type kneading machine 桨式混捏机paddle-wheel fan 叶轮式风扇paddock coat 男用紧腰骑马外衣paddy basket 谷箩paddy field cultivator 稻田中耕机paddy field harrow 水田耙paddy field plough 水田犁paddy field tractor 水田拖拉机paddy field weeder 稻田除草机paddy planter 水稻直播机paddy pounder 碾米机paddy transplanter 水稻插秧机paddy transplanting machine 水稻插秧机paddy 稻谷padimate 帕地马酯padisway silk 帕迭斯威棱纹绸padlette 帕德勒特凸花刺绣padlock 挂锁padmini 帕德米尼牌汽车padulasoy 棱纹花绸paejama 印度裤paeonia lactiflora pallas 白芍paeonia lactiflora 芍药paeonia suffruticosa 牡丹paesano hemp 帕瑟诺大麻page address register 页面。
Gold Tuning Solution, Part Number 8500-7000 Safety

Gold Tuning Solution, Part Number 8500-7000*************(24小时)化学品安全技术说明书GHS product identifier 应急咨询电话(带值班时间)::供应商/ 制造商:安捷伦科技贸易(上海)有限公司中国(上海)外高桥自由贸易试验区英伦路412号(邮编:200131)电话号码: 800-820-3278传真号码: 0086 (21) 5048 2818Gold Tuning Solution, Part Number 8500-7000化学品的推荐用途和限制用途8500-7000部件号:安全技术说明书根据 GB/ T 16483-2008 和 GB/ T 17519-2013GHS化学品标识:金调谐溶液, 部件号 8500-7000推荐用途:有关环境保护措施,请参阅第 12 节。
物质或混合物的分类根据 GB13690-2009 和 GB30000-2013紧急情况概述液体。
无色。
无气味的。
H290 - 可能腐蚀金属。
物理状态:颜色:气味:GHS危险性类别警示词:警告危险性说明:H290 - 可能腐蚀金属。
:防范说明预防措施:P234 - 仅在原包装内保存。
事故响应:P390 - 吸收溢出物,防止材料损坏。
安全储存:废弃处置:不适用。
标签要素象形图金属腐蚀物 - 类别 1物理和化学危险可能腐蚀金属。
健康危害没有明显的已知作用或严重危险。
::与物理,化学和毒理特性有关的症状皮肤接触食入吸入没有具体数据。
没有具体数据。
没有具体数据。
:::延迟和即时影响,以及短期和长期接触引起的慢性影响短期暴露潜在的即时效应:无资料。
潜在的延迟效应:无资料。
潜在的即时效应:无资料。
长期暴露潜在的延迟效应:无资料。
环境危害:没有明显的已知作用或严重危险。
其他危害:没有已知信息。
物质/混合物美国化学文摘社(CAS)编号/其它标识号:混合物就供应商当前已知,在所适用的浓度中,没有其它对健康或环境有害的成分需要在本章节报告。
Thermo Scientific

DATA SHEET 2D Labtainer BioProcess Containers2D Labtainer BioProcess Container (BPC) systemsWhether in standard or customized configurations, Labtainer BPCs are ideal for:• Dispensing, packaging, and storing cell culture media, buffers, and process liquids• Delivery of cell culture media or process liquids to small-scale bioprocess systems• Bioreactor and fermentation feed, sampling, and harvest • Chromatography feed and fraction collection• Storage and transport of bulk intermediate products, process intermediates, vaccine conjugates, and other biological productsSmall-volume liquid handling systems for cell culture and bioprocessingThermo Scientific ™ Labtainer ™ BioProcess Containers (BPCs) effectively address small-volume liquid handling needs. They range in size from 50 mL to 50 L, with avariety of standard configurations to meet most application needs. These Labtainer BPCs are space efficient, ergonomic, and constructed of Thermo Scientific ™Aegis ™ 5-14 and CX5-14 films. Product configurations cover a range of industry-standard connection systems, and handling systems are available for transport and storage.Standard productsStandard Labtainer BPCs are stocked for immediate delivery and are fully supported by our process and product validation program. For more information on our validation program, please refer to our validation guides for Aegis5-14 and CX5-14 films. Additionally, standard Labtainer BPCs have validated liquid shipping configurations.Standard configurations can be customized for optimal fit, form, and function to address process-specific applications using one of the industry’s largest libraries of qualified components.2D Labtainer BPCs are available with the Thermo Scientific ™ BioTitan ™ Retention Device. This universaltubing retention solution was designed to provide the best method for retaining flexible tubing on a barbed fitting and helps eliminate the risk of leaks and failure of the tubingconnection point.Table 1. Chamber information.50 mL–2 L, 2-port Labtainer BPC 2 L–50 L, 3-port Labtainer BPC2 L–50 L: Polyethylene ports are welded into the BPC seam: one 1/4 in. ID and two 3/8 in. ID ports on standard chamber.Table 2. Custom BPC options.Tubing type C-Flex™ (animal origin–free), silicone, PharMed™, or AdvantaFlex™Tubing size Specific lengths of 3.18–25.4 mm ID (1/8–1 in.); specific length depends on type of tubing chosenConnectors • Luer: 3.18–6.35 mm (1/8–1/4 in.) ID• CPC quick-connect: 6.35–19 mm (1/4–3/4 in.) ID• Steam-in-place connector: 6.35–19 mm (1/4–3/4 in.) ID• Tri-clamp: 3.18–25.4 mm (1/8–1 in.) ID• Mini tri-clamp: 3.18–12.7 mm (1/8–1/2 in.) ID• Aseptic connection and aseptic disconnection devices: all available sizes of Colder AseptiQuik™, Pall™ Kleenpak™, Cytiva ReadyMate™ DACOthers • Needle-free sample port (SmartSite™ or Clave™ products)• Filter capsule (Millipore™, Pall™, Sartorius™, Parker Bioscience™, Meissner™ products)Table 3. Presentation (as dry BPC systems).Outer packaging Supplied “flat-packed”—two polyethylene outer layersLabel • Description• Product code• Lot number• Expiration date on outer packaging and shipping containerSterilization Irradiation (25–40 kGy) inner side of outer packaging Shipping container Durable cardboard cartonDocumentation • Certificate of Analysis provided with each batch for each delivery • Certificate of Irradiation2 portsPack of 10Line 1Luer lock body connection, polypropyleneTubing: C-Flex; 30 cm (12 in.) lengthID x OD: 3.18 x 6.35 mm (0.125 x 0.25 in.)Line 2Luer lock insert connection, polypropyleneTubing: C-Flex; 30 cm (12 in.) lengthID x OD: 3.18 x 6.35 mm (0.125 x 0.25 in.) Line 1Luer lock body connection, polypropyleneTubing: C-Flex; 8 cm (3 in.) lengthID x OD: 6.35 x 10.92 mm (0.25 x 0.43 in.)Line 2Luer lock insert connection, polypropyleneTubing: C-Flex; 8 cm (3 in.) lengthID x OD: 6.35 x 10.92 mm (0.25 x 0.43 in.)Line 1Luer lock body connection, polypropyleneTubing: C-Flex; 30 cm (12 in.) lengthID x OD: 3.18 x 6.35 mm (0.125 x 0.25 in.)Line 2MPC insert, polycarbonateTubing: C-Flex; 8 cm (3 in.) lengthID x OD: 3.18 x 6.35 mm (0.125 x 0.25 in.)2 portsPack of 10Pack of 10Line 1Luer lock insert connection, polypropyleneTubing: C-Flex; 30 cm (12 in.) length ID x OD: 6.35 x 9.7 mm (0.25 x 0.38 in.)Line 2Luer lock body connection, polypropylene Tubing: C-Flex; 30 cm (12 in.) length ID x OD: 6.35 x 9.7 mm (0.25 x 0.38 in.)Line 3Luer lock body connection, polypropylene Tubing: C-Flex; 30 cm (12 in.) lengthID x OD: 3.18 x 6.35 mm (0.125 x 0.25 in.)Line 1MPC insert, polycarbonateTubing: C-Flex; 61 cm (24 in.) length ID x OD: 9.7 x 15.9 mm (0.38 x 0.63 in.)Line 2MPC body, polycarbonateTubing: C-Flex; 61 cm (24 in.) length ID x OD: 9.7 x 15.9 mm (0.38 x 0.63 in.)Line 3Luer lock body connection, polypropylene Tubing: C-Flex; 61 cm (24 in.) length ID x OD: 3.18 x 6.35 mm (0.125 x 0.25 in.)Line 1MPC insert, polycarbonateTubing: C-Flex; 30 cm (12 in.) length ID x OD: 9.7 x 12.7 mm (0.38 x 0.5 in.)Line 2MPC insert, polycarbonateTubing: C-Flex; 30 cm (12 in.) length ID x OD: 9.7 x 12.7 mm (0.38 x 0.5 in.)Line 3End plug, polypropyleneTubing: C-Flex; 8 cm (3 in.) lengthID x OD: 6.35 x 10.92 mm (0.25 x 0.43 in.)3 portsSingle pack3 portsSingle packSingle pack—edge portsLine 1MPC insert, polycarbonateTubing: C-Flex; 8 cm (3 in.) lengthID x OD: 9.6 x 12.7 mm (0.378 x 0.50 in.)Line 2MPC insert, polycarbonateTubing: C-Flex; 8 cm (3 in.) lengthID x OD: 9.6 x 12.7 mm (0.378 x 0.50 in.)Line 3Injection portTubing: C-Flex; 8 cm (3 in.) lengthID x OD: 6.35 x 9.53 mm (0.25 x 0.375 in.)Note: Aegis5-14 film equivalents for this product areavailable as custom configurations.Line 1MPC insert, polycarbonateTubing: C-Flex; 46 cm (18 in.) lengthID x OD: 3.18 x 6.35 mm (0.125 x 0.25 in.)Line 2MPC body, polypropyleneTubing: C-Flex; 61 cm (24 in.) lengthID x OD: 9.53 x 15.875 mm (0.375 x 0.625 in.)Line 3Luer lock body connection, polypropyleneTubing: C-Flex; 61 cm (24 in.) lengthID x OD: 9.53 x 15.875 mm (0.375 x 0.625 in.)3 portsSingle pack—pillow design withpanel portsFind out more at /bpcFor Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.© 2021 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unlessotherwise specified. C-Flex and PharMed are trademarks of Saint-Gobain Performance Plastics. AdvantaFlex is a trademark of NewAge Industries, Inc. AseptiQuik is a trademark of Colder Products Company. Pall and Kleenpak are trademarks of Pall Corporation. ReadyMate is a trademark of Cytiva. SmartSite is a trademark of Becton, Dickinson and Company. Clave is a trademark of Victus Inc. Millipore is a trademark of Merck KGaA, Darmstadt, Germany and/or its affiliates. Meissner is a trademark of Meissner Filtration Products. Parker Bioscience is a trademark of Parker Hannifin Corp. Rubbermaid is a trademark of Rubbermaid Incorporated. Sartorius is a trademark of Sartorius AG. Specifications, terms, and pricing are subject toIndustry-standard Rubbermaid ™ totes with corresponding lids are available. They can be used to protect Labtainer BPCs up to 20 L in size during use, transport, and storage. Use standard 50 L drums for 50 L Labtainer BPCs.Tray with lidFlat-bottom, linear low-density polyethylene (LLDPE) drum with lid。
ELASTOMERIC CLOSURES FOR INJECTIONS(注射剂橡胶塞)USP40

CALCULATIONCalculate the cobalamin content, expressed in m g of cyanocobalamin, of the portion taken for assay by the formula:R(C S /C U )(A U /A S )in which R is the quantity, in m g, of cyanocobalamin in the portion of the standard solution taken; C S and C U are the corrected average radioactivity values, expressed in counts per minute per mL, of the standard and assay solutions, respectively; and A Uand A Sare the absorbances determined at 361 nm of the assay and standard solutions, respectively.á381ñ ELASTOMERIC CLOSURES FOR INJECTIONSINTRODUCTIONElastomeric closures for containers used in the types of preparations defined in the general test chapter Injections and Im-planted Drug Products á1ñ are made of materials obtained by vulcanization (cross-linking) polymerization, polyaddition, or poly-condensation of macromolecular organic substances (elastomers). Closure formulations contain natural or synthetic elastomers and inorganic and organic additives to aid or control vulcanization, impart physical and chemical properties or color, or stabi-lize the closure formulation.This chapter applies to closures used for long-term storage of preparations defined in the general test chapter Packaging andStorage Requirements á659ñ, Injection Packaging . Such closures are typically used as part of a vial, bottle, or pre-fill syringe pack-age system.This chapter applies to closures formulated with natural or synthetic elastomeric substances. This chapter does not apply toclosures made from silicone elastomer; however, it does apply to closures treated with silicone (e.g., Dimethicone, NF ). Whenperforming the tests in this chapter, it is not required that closures be treated with silicone, although there is no restrictionprohibiting the use of siliconized closures.This chapter also applies to closures coated with other lubricious materials (e.g., materials chemically or mechanically bon-ded to the closure) that are not intended to, and in fact do not provide, a barrier to the base elastomer. When performing the tests, closures with lubricious nonbarrier coatings are to be tested in their coated state.The following comments relate solely to closures laminated or coated with materials intended to provide, or in fact function as, a barrier to the base elastomer (e.g., PTFE or lacquer coatings). It is not permissible to use a barrier material in an attempt to change a closure that does not meet compendial requirements to one that does conform. Therefore, all Physicochemical Tests apply to the base formula of such closures, as well as to the coated or laminated closure. To obtain Physicochemical Tests results, the tests are to be performed on uncoated or nonlaminated closures of the same elastomeric compound, as well as to the laminated or coated closure. The Functionality Tests apply to and are to be performed using the laminated or coated elasto-meric closure. Biological Tests apply to the lamination or coating material, as well as to the base formula. Biological Tests may be performed on the laminated or coated closure, or they may be performed on the laminate/coating material and the uncoa-ted or nonlaminated closures of the same elastomeric compound. In the latter case, the results are to be reported separately.The base formula used for physicochemical or biological tests intended to support the compendial compliance of a barrier-coated closure should be similar to the corresponding coated closure in configuration and size.For all Nephelometry, Turbidimetry, and Visual Comparison á855ñ tests performed on any closure type, it is important to docu-ment the closure being tested, including a full description of the elastomer, and any lubrication, coating, laminations, or treat-ments applied.This chapter states test limits for Type I and Type II elastomeric closures. Type I closures are typically used for aqueous prepa-rations. Type II closures are typically intended for nonaqueous preparations and are those which, having properties optimized for special uses, may not meet all requirements listed for Type I closures because of physical configuration, material of con-struction, or both. If a closure fails to meet one or more of the Type I test requirements, but still meets the Type II require-ments for the test(s), the closure is assigned a final classification of Type II. All elastomeric closures suitable for use with injecta-ble preparations must comply with either Type I or Type II test limits. However, this specification is not intended to serve as the sole evaluation criteria for the selection of such closures.It is appropriate to use this chapter when identifying elastomeric closures that might be acceptable for use with injectable preparations on the basis of their biological reactivity, their aqueous extract physicochemical properties, and their functionali-ty.The following closure evaluation requirements are beyond the scope of this chapter:—The establishment of closure identification tests and specifications—The verification of closure–product physicochemical compatibility—The identification and safety determination of closure leachables found in the packaged product—The verification of packaged product closure functionality under actual storage and use conditions326 á371ñ Cobalamin Radiotracer Assay / Chemical Tests USP 40The manufacturer of the injectable product (the end user) must obtain from the closure supplier an assurance that the com-position of the closure does not vary and that it is the same as that of the closure used during compatibility testing. When the supplier informs the end user of changes in the composition, compatibility testing must be repeated, totally or partly, depend-ing on the nature of the changes. Closures must be properly stored, cleaned for removal of environmental contaminants and endotoxins, and, for aseptic processes, sterilized prior to use in packaging injectable products.CHARACTERISTICSElastomeric closures are translucent or opaque and have no characteristic color, the latter depending on the additives used. They are homogeneous and practically free from flash and adventitious materials (e.g., fibers, foreign particles, and waste rub-ber.)IDENTIFICATIONClosures are made of a wide variety of elastomeric materials and optional polymeric coatings. For this reason, it is beyond the scope of this chapter to specify identification tests that encompass all possible closure presentations. However, it is the responsibility of the closure supplier and the injectable product manufacturer (the end user) to verify the closure elastomeric formulation and any coating or laminate materials used according to suitable identification tests. Examples of some of the ana-lytical test methodologies that may be used include specific gravity, percentage of ash analysis, sulfur content determination, FTIR-ATR test, thin-layer chromatography of an extract, UV absorption spectrophotometry of an extract, or IR absorption spec-trophotometry of a pyrolysate.TEST PROCEDURESElastomeric closures shall conform to biological, physicochemical, and functionality requirements both as they are shipped by the closure supplier to the injectable product manufacturer (the end user), and in their final ready-to-use state by the end user.For those elastomeric closures processed by the supplier prior to distribution to the end user, the supplier shall demonstrate compendial conformance of closures exposed to such processing and/or sterilization steps. Similarly, if elastomeric closures re-ceived by the end user are subsequently processed or sterilized, the end user is responsible for demonstrating the continued conformance of closures to compendial requirements subsequent to such processing and/or sterilization conditions (i.e., in their ready-to-use state). This is especially important if closures shall be exposed to processes or conditions that may signifi-cantly impact the biological, physicochemical, or functionality characteristics of the closure (e.g., gamma irradiation).For closures that are normally lubricated with silicone prior to use, it is permissible to perform physicochemical testing on nonlubricated closures, in order to avoid potential method interference and/or difficulties in interpreting test results. For clo-sures supplied with other lubricious nonbarrier coatings, all tests are to be performed using the coated closure.For closures coated or laminated with coatings intended to provide a barrier function (e.g., PTFE or lacquer coatings), physi-cochemical compendial tests apply to the uncoated base elastomer, as well as to the coated closure. In this case, suppliers are responsible for demonstrating physicochemical compendial compliance of the coated closure, as well as of the uncoated clo-sure, processed or treated in a manner simulating conditions typically followed by the supplier for such coated closures prior to shipment to the end user. The uncoated closure subject to physicochemical tests should be similar to the corresponding coat-ed closure in size and configuration. End users of coated closures are also responsible for demonstrating the continued physi-cochemical compendial conformance of the coated closure, processed or treated in a manner simulating conditions typically employed by the end user prior to use.In all cases, it is appropriate to document all conditions of closure processing, pretreatment, sterilization, or lubrication when reporting test results.Table 1 summarizes the testing requirements of closures, and the responsibilities of the supplier and the end user.Table 1Closure Types(As Supplied or Used)Test RequirementsPhysicochemical Tests Functionality Tests Biological TestsClosure with or withoutSilicone Coating• Tests are to be performed.• Tests are to be performed.• Tests are to be performed.• Silicone use is optional.• Silicone use is optional.• Silicone use is optional.• Responsibility: supplier and enduser• Responsibility: supplier and enduser• Responsibility: supplier and enduserClosures with LubriciousCoating (NonbarrierMaterial; Not Silicone)• Tests are to be performed oncoated closures.• Tests are to be performed oncoated closures.• Tests are to be performed oncoated closures.• Responsibility: supplier and enduser• Responsibility: supplier and enduser• Responsibility: supplier and enduserUSP 40Chemical Tests / á381ñ Elastomeric Closures for Injections 327Table 1 (Continued)Closure Types (As Supplied or Used)Test RequirementsPhysicochemical Tests Functionality Tests Biological TestsClosures with Barrier Coating • Tests are to be performed on coated closures.• Tests are to be performed on coated closures.• Tests are to be performed oncoated closures.• Responsibility: supplier and enduser • Responsibility: supplier and end user OR:AND:• Tests are to be performed on un-coated closures (base formula) andthe laminate/coating material (re-port results separately).• Tests are to be performed on un-coated closures (base formula).• Responsibility: supplier • Responsibility: supplier and end userBIOLOGICAL TESTSTwo stages of testing are indicated. The first stage is the performance of an in vitro test procedure as described in general test chapter Biological Reactivity Tests, In Vitro á87ñ. Materials that do not meet the requirements of the in vitro test are subjec-ted to the second stage of testing, which is the performance of the in vivo tests, Systemic Injection Test and Intracutaneous Test ,according to the procedures set forth in the general test chapter Biological Reactivity Tests, In Vivo á88ñ. Materials that meet therequirements of the in vitro test are not required to undergo in vivo testing.Type I and Type II closures must both conform to the requirements of either the in vitro or the in vivo biological reactivitytests. [N OTE —Also see the general information chapter The Biocompatibility of Material Used in Drug Containers, Medical Devices,and Implants á1031ñ.]PHYSICOCHEMICAL TESTSPreparation of Solution SPlace whole, uncut closures corresponding to a surface area of 100±10 cm 2into a suitable glass container. Cover the clo-sures with 200 mL of Purified Water or Water for Injection. If it is not possible to achieve the prescribed closure surface area (100±10 cm 2) using uncut closures, select the number of closures that will most closely approximate 100 cm 2, and adjust the volume of water used to the equivalent of 2 mL per each 1 cm 2 of actual closure surface area used. Boil for 5 minutes, and rinse five times with cold Purified Water or Water for Injection.Place the washed closures into a Type I glass wide-necked flask (see Containers—Glass á660ñ), add the same quantity of Puri-fied Water or Water for Injection initially added to the closures, and weigh. Cover the mouth of the flask with a Type I glass beaker. Heat in an autoclave so that a temperature of 121±2° is reached within 20 to 30 minutes, and maintain this tempera-ture for 30 minutes. Cool to room temperature over a period of about 30 minutes. Add Purified Water or Water for Injection to bring it up to the original mass. Shake, and immediately decant and collect the solution. [N OTE —This solution must be shaken before being used in each of the tests.]Preparation of BlankPrepare a blank solution similarly, using 200 mL of Purified Water or Water for Injection omitting the closures.A PPEARANCE OF S OLUTION (T URBIDITY /O PALESCENCE AND C OLOR )Determination of Turbidity (Opalescence)N OTE —The determination of turbidity may be performed by visual comparison (Procedure A ), or instrumentally using a suita-ble ratio turbidimeter (Procedure B ). For a discussion of turbidimetry, see Nephelometry, Turbidimetry, and Visual Comparison á855ñ. Instrumental assessment of clarity provides a more discriminatory test that does not depend on the visual acuity of the analyst.Hydrazine Sulfate Solution—Dissolve 1.0 g of hydrazine sulfate in water and dilute with water to 100.0 mL. Allow to stand for 4 to 6 hours.Hexamethylenetetramine Solution—Dissolve 2.5 g of hexamethylenetetramine in 25.0 mL of water in a 100-mL glass-stop-pered flask.Opalescence Stock Suspension—Add 25.0 mL of Hydrazine Sulfate Solution to the Hexamethylenetetramine Solution in the flask.Mix, and allow to stand for 24 hours. This suspension is stable for 2 months, provided it is stored in a glass container free from surface defects. The suspension must not adhere to the glass and must be well mixed before use.328 á381ñ Elastomeric Closures for Injections / Chemical Tests USP 40Opalescence Standard Suspension—Prepare a suspension by diluting 15.0 mL of the Opalescence Stock Suspension with water to 1000.0 mL. Opalescence Standard Suspension is stable for about 24 hours after preparation.Reference Suspensions—Prepare according to Table 2. Mix and shake before use. [N OTE—Stabilized formazin suspensions that can be used to prepare stable, diluted turbidity standards are available commercially and may be used after comparison with the standards prepared as described.]Table 2Reference Suspension A Reference Suspension B Reference Suspension C Reference Suspension D Standard of Opalescence 5.0 mL10.0 mL30.0 mL50.0 mLWater95.0 mL90.0 mL70.0 mL50.0 mL Nephelometric TurbidityUnits 3 NTU 6 NTU18 NTU30 NTU Procedure A: Visual Comparison—Use identical test tubes made of colorless, transparent, neutral glass with a flat base and an internal diameter of 15 to 25 mm. Fill one tube to a depth of 40 mm with Solution S, one tube to the same depth with water, and four others to the same depth with Reference Suspensions A, B, C, and D. Compare the solutions in diffuse daylight 5 mi-nutes after preparation of the Reference Suspensions, viewing vertically against a black background. The light conditions shall be such that Reference Suspension A can be readily distinguished from water and that Reference Suspension B can be readily distinguished from Reference Suspension A.R EQUIREMENT—Solution S is not more opalescent than Reference Suspension B for Type I closures, and not more opalescent than Reference Suspension C for Type II closures. Solution S is considered clear if its clarity is the same as that of water when examined as described above, or if its opalescence is not more pronounced than that of Reference Suspension A (refer to Table 3).Procedure B: Instrumental Comparison—Measure the turbidity of the Reference Suspensions in a suitable calibrated turbidime-ter (see á855ñ). The blank should be run and the results corrected for the blank. Reference Suspensions A, B, C, and D represent 3, 6, 18, and 30Nephelometric Turbidity Units (NTU), respectively. Measure the turbidity of Solution S using the calibrated turbidimeter.R EQUIREMENT—The turbidity of Solution S is not greater than that for Reference Suspension B (6NTU FTU) for Type I closures, and is not greater than that for Reference Suspension C (18NTU FTU) for Type II closures (refer to Table 3).Table 3Comparison MethodOpalescenceRequirements Procedure A (Visual)Procedure B(Instrumental)Type I closures No more opalescent than Suspension B No more than 6 NTUType II closures No more opalescent than Suspension CNo more than 18 NTU Determination of ColorColor Standard—Prepare a solution by diluting 3.0 mL of Matching Fluid O (see Color and Achromicity á631ñ) with 97.0 mL of diluted hydrochloric acid.Procedure—Use identical tubes made of colorless, transparent, neutral glass with a flat base and an internal diameter of 15 to 25 mm. Fill one tube to a depth of 40 mm with Solution S, and the second with the Color Standard. Compare the liquids in diffuse daylight, viewing vertically against a white background.Requirement—Solution S is not more intensely colored than the Color Standard.Acidity or AlkalinityBromothymol Blue Solution—Dissolve 50 mg of bromothymol blue in a mixture of 4 mL of 0.02 M sodium hydroxide and 20 mL of alcohol. Dilute with water to 100 mL.Procedure—To 20 mL of Solution S add 0.1 mL of Bromothymol Blue Solution. If the solution is yellow, titrate with 0.01 N sodium hydroxide until a blue endpoint is reached. If the solution is blue, titrate with 0.01 N hydrochloric acid until a yellow endpoint is reached. If the solution is green, it is neutral and no titration is required.Blank Correction—Test 20 mL of Blank similarly. Correct the results obtained for Solution S by subtracting or adding the vol-ume of titrant required for the Blank, as appropriate. (Reference Titrimetry á541ñ.)Requirement—Not more than 0.3 mL of 0.01 N sodium hydroxide produces a blue color, or not more than 0.8 mL of 0.01 N hydrochloric acid produces a yellow color, or no titration is required.AbsorbanceProcedure—[N OTE—Perform this test within 5 hours of preparing Solution S.] Pass Solution S through a 0.45-m m pore size filter, discarding the first few mL of filtrate. Measure the absorbance of the filtrate at wavelengths between 220 and 360 nm in USP 40Chemical Tests / á381ñ Elastomeric Closures for Injections 329a 1-cm cell using the blank in a matched cell in the reference beam. If dilution of the filtrate is required before measurement of the absorbance, correct the test results for the dilution.Requirement—The absorbances at these wavelengths do not exceed 0.2 for Type I closures or 4.0 for Type II closures.Reducing SubstancesProcedure— [N OTE —Perform this test within 4 hours of preparing Solution S .] To 20.0 mL of Solution S add 1 mL of diluted sulfuric acid and 20.0 mL of 0.002 M potassium permanganate. Boil for 3 minutes. Cool, add 1g of potassium iodide, and titrate immediately with 0.01 M sodium thiosulfate, using 0.25 mL of starch solution TS as the indicator. Perform a titration using 20.0 mL of blank and note the difference in volume of 0.01 M sodium thiosulfate required.Requirement—The difference between the titration volumes is not greater than 3.0 mL for Type I closures and not greater than 7.0 mL for Type II closures.Heavy MetalsProcedure—Proceed as directed for Method I under Heavy Metals á231ñ. Prepare the Test Preparation using 10.0 mL of Solu-tion S .Requirement—Solution S contains not more than 2 ppm of heavy metals as lead.Extractable ZincTest Solution—Prepare a Test Solution by diluting 10.0 mL of Solution S to 100 mL with 0.1 N hydrochloric acid. Prepare atest blank similarly, using the Blank for Solution S .Zinc Standard Solution—Prepare a solution (10 ppm Zn) by dissolving zinc sulfate in 0.1 N hydrochloric acid.Reference Solutions—Prepare not fewer than three Reference Solutions by diluting the Zinc Standard Solution with0.1 N hydrochloric acid. The concentrations of zinc in these Reference Solutions are to span the expected limit of the Test Solu-tion .Procedure—Use a suitable atomic absorption spectrophotometer (see Atomic Absorption Spectroscopy á852ñ) equipped with a zinc hollow-cathode lamp and an air–acetylene flame. An alternative procedure such as an appropriately validated inductively coupled plasma analysis (ICP) may be used.Test each of the Reference Solutions at the zinc emission line of 213.9 nm at least three times. Record the steady readings.Rinse the apparatus with the test blank solution each time, to ensure that the reading returns to initial blank value. Prepare a calibration curve from the mean of the readings obtained for each Reference Solution . Record the absorbance of the Test Solu-tion . Determine the ppm zinc concentration of the Test Solution using the calibration curve.Requirement—Solution S contains not more than 5 ppm of extractable zinc.AmmoniumAlkaline Potassium Tetraiodomercurate Solution—Prepare a 100 mL solution containing 11g of potassium iodide and 15g of mercuric iodide in water. Immediately before use, mix 1 volume of this solution with an equal volume of a 250g per L solution of sodium hydroxide.Test Solution—Dilute 5 mL of Solution S to 14 mL with water. Make alkaline if necessary by adding 1N sodium hydroxide,and dilute with water to 15 mL. Add 0.3 mL of Alkaline Potassium Tetraiodomercurate Solution, and close the container.Ammonium Standard Solution—Prepare a solution of ammonium chloride in water (1 ppm NH4). Mix 10 mL of the 1 ppmammonium chloride solution with 5 mL water and 0.3 mL of Alkaline Potassium Tetraiodomercurate Solution. Close the contain-er.Requirement—After 5 minutes, any yellow color in the Test Solution is no darker than the Ammonium Standard Solution (no more than 2 ppm of NH 4 in Solution S ).Volatile SulfidesProcedure—Place closures, cut if necessary, with a total surface area of 20±2 cm 2 in a 100-mL flask, and add 50 mL of a 20g per L citric acid solution. In the same manner and at the same time, prepare a control solution in a separate 100-mL flask by dissolving 0.154 mg of sodium sulfide in 50 mL of a 20g per L citric acid solution. Place a piece of lead acetate paper over the mouth of each flask, and hold the paper in position by placing over it an inverted weighing bottle. Heat the flasks in an autoclave at 121±2° for 30 minutes.Requirement—Any black stain on the paper produced by the test solution is not more intense than that produced by thecontrol substance.330 á381ñ Elastomeric Closures for Injections / Chemical Tests USP 40FUNCTIONALITY TESTSN OTE—Samples treated as described for preparation of Solution S and air dried should be used for Functionality Tests of Pene-trability, Fragmentation, and Self-Sealing Capacity. Functionality Tests are performed on closures intended to be pierced by a hy-podermic needle. The Self-Sealing Capacity test is required only for closures intended for multiple-dose containers. The needle specified for each test is a lubricated long bevel (bevel angle 12±2°) hypodermic needle1.PenetrabilityProcedure—Fill 10 suitable vials to the nominal volume with water, fit the closures to be examined, and secure with a cap. Using a new hypodermic needle as described above for each closure, pierce the closure with the needle perpendicular to the surface.Requirement—The force for piercing is no greater than 10N (1kgf) for each closure, determined with an accuracy of ±0.25 N (25gf).FragmentationClosures for Liquid Preparations—Fill 12 clean vials with water to 4 mL less than the nominal capacity. Fit the closures to be examined, secure with a cap, and allow to stand for 16 hours.Closures for Dry Preparations—Fit closures to be examined into 12 clean vials, and secure each with a cap.Procedure—Using a hypodermic needle as described above fitted to a clean syringe, inject into each vial 1 mL of water while removing 1 mL of air. Repeat this procedure four times for each closure, piercing each time at a different site. Use a new nee-dle for each closure, checking that it is not blunted during the test. Filter the total volume of liquid in all the vials through a single filter with a nominal pore size no greater than 0.5 m m. Count the rubber fragments on the surface of the filter visible to the naked eye.Requirement—There are no more than five fragments visible. This limit is based on the assumption that fragments with a diameter >50 m m are visible to the naked eye. In case of doubt or dispute, the particles are examined microscopically to verify their nature and size.Self-Sealing CapacityProcedure—Fill 10 suitable vials with water to the nominal volume. Fit the closures that are to be examined, and cap. Using a new hypodermic needle as described above for each closure, pierce each closure 10 times, piercing each time at a different site. Immerse the 10 vials in a solution of 0.1% (1g per L) methylene blue, and reduce the external pressure by 27kPa for 10 minutes. Restore to atmospheric pressure, and leave the vials immersed for 30 minutes. Rinse the outside of the vials.Requirement—None of the vials contain any trace of blue solution.á391ñ EPINEPHRINE ASSAYASSAYFerro-citrate solution:On the day needed, dissolve 1.5 g of ferrous sulfate in 200 mL of water to which have been added 1.0 mL of dilute hydrochloric acid (1 in 12) and 1.0 g of sodium bisulfite. Dissolve 500 mg of sodium citrate in 10 mL of this solution, and mix.Buffer solution:In a 50-mL volumetric flask mix 4.2 g of sodium bicarbonate, 5.0 g of potassium bicarbonate, and 18 mL of water (not all of the solids will dissolve at this stage). To another 18 mL of water add 3.75 g of aminoacetic acid and 1.7 mL of 6N ammonium hydroxide, mix to dissolve, and transfer this solution to the 50-mL volumetric flask containing the other mixture. Dilute with water to volume, and mix until solution is complete.Standard preparation:Transfer about 18 mg of USP Epinephrine Bitartrate RS, accurately weighed, to a 100-mL volumet-ric flask with the aid of 20 mL of sodium bisulfite solution (1 in 50), dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with sodium bisulfite solution (1 in 500) to volume, and mix. [N OTE—Make the final dilution when the assay is carried out.] The concentration of USP Epinephrine Bitartrate RS in the Standard prepara-tion is about 18 m g per mL.Assay preparation:Transfer to a 50-mL volumetric flask an accurately measured volume of the Injection under assay, equivalent to about 500 m g of epinephrine, dilute with sodium bisulfite solution (1 in 500) to volume, if necessary, and mix. [N OTE—The final concentration of sodium bisulfite is in the range of 1 to 3 mg per mL, any bisulfite present in the Injection under assay being taken into consideration.]1Refer to ISO 7864, Sterile hypodermic needles for single use with an external diameter of 0.8 mm (21 Gauge).USP 40Chemical Tests / á391ñ Epinephrine Assay 331。
SensiMix

Shipping: On Dry/Blue Ice Catalog Numbers Batch No.: See vial Concentration: See vial QT605-05: 500 x 50 μL reactions: 10 x 1.25 mL Storage and Stability:SensiMix SYBR ®Hi --20 °C upon receipt. Excessive freeze/thawing is not recommended. Expiry:When stored under the recommended conditions and handled correctly, full activity of the kit is retained until the expiry date on the outer box label.Quality Control:SensiMix SYBR ®Hi -ROX Kit and its components are extensively tested for activity,processivity, efficiency, heat activation, sensitivity, absence of nuclease contamination andabsence of nucleic acid contamination prior to release.Safety Precautions:Please refer to the material safety data sheet for further information.Notes:For research or further manufacturing use only. Trademarks:SensiMix, SensiFAST (Bioline Reagents Ltd), SYBR (Molecular Probes), ROX, LightCycler (Roche), StepOne (ABI), RotorGene (Qiagen), LightCycler (Roche).Kit componentsStore at –20 °CThe SensiMix SYBR ® Hi -ROX Kit has been optimized for use in SYBR ® Green -based qPCR on the real -time instruments listed in the following compatibility table, each of these instruments having the capacity to analyze the qPCR data with the passive reference signal either on or off. The kit is also compatible with several instruments that do not require the use of ROX, such as the BMS Mic, Qiagen Rotor -Gene ™ 6000, Bio -Rad CFX96 or Roche LightCycler ® 480.DescriptionThe SensiMix ™ SYBR ® Hi -ROX Kit is a high -performance reagent designed for superior sensitivity and specificity on various real -time instruments. The SensiMix SYBR ® Hi -ROX Kit employs a hot -start DNA polymerase, for high PCR specificity and sensitivity. SensiMix SYBR ® Hi -ROX is inactivated and possesses no polymerase activity during the reaction set -up, preventing non -specific amplification including primer -dimer formation.For ease -of -use and added convenience, SensiMix SYBR ® Hi -ROX is provided as a 2x master mix containing all the components necessary for real -time PCR (qPCR), including the SYBR ® Green I dye, dNTPs, stabilizers and ROX for optional use. As a ready -to -use premix, only primers and template need to be added. Kit compatibilityPrimers: the sequence and concentration of primer as well as the amplicon length can be critical for specific amplification, yield and overall efficiency of any qPCR. We strongly recommend taking the following into consideration when designing and running your PCR reaction:• use primer -design software, such as Primer3 or visual OMP TM (/primer3/ and DNA Software, Inc ; / respectively). Primers should have a melting temperature (Tm) of approximately 60 °C• optimal amplicon length should be 50-150 bp• a final primer concentration of 250 nM is suitable for most PCR conditions, however to determine the optimal concentration we recommend a primer titration in the range of 0.1–1 μM• use equimolar primer concentrations• when amplifying from cDNA use gene -specific primers. If possible use intron -spanning primers to avoid amplification from genomic DNATemplate: it is important that the DNA template is suitable for use in PCR in terms of purity and concentration. Also, the template needs to be devoid of any contaminating PCR inhibitors (e.g. EDTA). The recommended amount of template for PCR is dependent upon the type of DNA used. The following should be considered when using genomic DNA and cDNA templates:• Genomic DNA: use up to 1 μg of complex (e.g. eukaryotic) genomic DNA in a single PCR. We recommend using the ISOLATE Genomic II DNA Mini Kit (BIO -52066) for high yield and purity from both prokaryotic and eukaryotic sources• cDNA: the optimal amount of cDNA to use in a single PCR is dependent upon the copy number of the target gene. We suggest using 100 ng cDNA per reaction, however it may be necessary to vary this amount. To perform a two -step RT -PCR, we recommend using the SensiFAST cDNA Synthesis Kit (BIO -65053) for reverse transcription of the purified RNA. For high yield and purity of RNA, use the ISOLATE II RNA Mini Kit (BIO -52072)General considerationsTo help prevent any carry -over DNA contamination we recommend that separate areas be maintained for PCR set -up, PCR amplification and any post -PCR gel analysis. It is essential that any amplified PCR product should not be opened in the PCR set -up area.Website:/sensimixemail:****************************PI -50231 V11__________________________________________________________________________________________________________________________LICENSING INFORMATION2) Purchase of this product conveys a licence from Life Technologies to use this SYBR ® containing reagent in an end -user RUO assay. Parties wishing to incorporate this SYBR ® containing reagent into a downstream kit, should contact Life Technologies for SYBR ® Licencing information.Website:/sensimixemail:****************************Associated ProductsBioline Reagents Ltd UNITED KINGDOMTel: +44 (0)20 8830 5300 Fax: +44 (0)20 8452 2822Meridian Life Science Inc. USATel: +1 901 382 8716 Fax: +1 901.382.0027Bioline GmbH GERMANYTel: +49(0)3371 60222 00 Fax: +49(0)3371 60222 01Bioline (Aust) Pty. Ltd AUSTRALIATel: +61 (0)2 9209 4180 Fax: +61 (0)2 9209 4763Technical SupportIf the troubleshooting guide does not solve the difficulty you are experiencing, please contact Technical Support with details of reaction setup, cycling conditions and relevant data. Email: ********************************MgCl 2: The MgCl 2 concentration in the 1x reaction mix is 3 mM. In the majority of qPCR conditions this is optimal for both the reverse transcriptase and the hot -start DNA polymerase. If necessary, we suggest titrating the MgCl 2 to a maximum of 5mM.PCR controls: It is important to detect the presence of contaminating DNA that may affect the reliability of the data. Always include a no template control (NTC), replacing the template with PCR -grade water. When performing a two -step RT -qPCR, set -up a no RT control as the NTC for the PCR.ProcedureReaction mix composition: Prepare a PCR master mix. The volumes given below are based on a standard 50 μL final reaction mix and can be scaled accordingly.Optional ROX: The SensiMix ™SYBR Hi -ROX Kit is premixed with ROX (5-carboxy -X -rhodamine, succinymidyl ester), so that where necessary, ROX fluorescence can be optionally detected on certain real -time instruments. If your real -time instrument has the capability of using ROX and you wish to use this option, then this option must be selected by the user in the software.Troubleshooting GuideSuggested thermal cycling conditionsThe PCR conditions described below are suitable for the SensiMix ™ SYBR ® Hi -ROX Kit for the majority of amplicons and real -time PCR instruments. However, the cycling conditions can be varied to suit customer or machine -specific protocols. The critical step of the PCR is the 10 minute initial activation at 95 °C. The detection channel on the real -time instrument should be set to (SYBR ®) Green or FAM.*Non -variable parameterOptional analysis:After the reaction has reached completion refer to the instrument instructions for the option of melt -profile analysis.Website:/sensimixemail:****************************Website:/sensimixemail:****************************Troubleshooting Guide (Continued)。
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908737 - Post Closing in Material LedgerSymptomYou would like some clarification on how the system works in step 'Post Closing' for costing run in transaction CKMLCP.Other TermsCNACT, Post closing, CKMLCP, FI accounts, Posting LogicReason and PrerequisitesThe material ledger and is active and material has price determination 3SolutionIf you do not fully understand the 'Post closing' step in CKMLCP or how the FI accounts are posted when running this step, this SAP note should help you for the analysis. It provides explanations for how the values arose in the different FI accounts.During the periodic transactions price/exchange rate differences are recorded under different transaction keys:PRD ( ) Price differences from purchase orderPRD (PRF) Price differences from goods receipt with external value from order settlement.KDM Exchange rate differences from goods receipts, with external value from order settlement.AUM Price differences and exchange rate differences from stock transferAKO Price differences from stock transfer consignment stock to ownAt the end of the period, by running transaction CKMLCP, the Material Ledger settles the differences to the different receivers according to the actual movements of the period.Transaction CKM3 shows, how the differences were distributed to the different receivers.By executing the CKMLCP step 'Closing Entries' these results are posted in FI.The Material Ledger postings use own transaction keys for price/exchange rate difference acccounts:PRY Price differences from same (upper) levelPRV Price differences from lower levelKDM Exchange rate differences from same (upper) levelKDV Exchange rate differences from lower levelPRM Differences of cancelled WIP (Materials)PRA Differences of cancelled WIP (Activities)For the offset postings the following transaction keys are used:BSX Inventory postingLKW Accruals and defer.acct.(Material ledger)UMB Gain/loss from revaluationCOC Revaluation of other consumablesWPM WIP from Price Differences (Material)WPA WIP from Price Differences (Int. Acty)GBB (AUI) Cost Center Crediting from ActivitiesThe different postings that occur in Material Ledger are:1. ROLL UP OF PRICE/EXCHANGE RATE DIFFERENCES* from input material to output material.INPUT MATERIAL OUTPUT MATERIALPRY PRV -> PRVKDM KDV -> KDV* from input activity/business process to output material.COST CENTER OUTPUT MATERIALGBB(AUI) -> PRV* from WIP input material to output material.INPUT MATERIAL OUTPUT MATERIALPRM -> PRV* from WIP input activity/business process to output material.INPUT ACTIVITY/BP OUTPUT MATERIALPRA -> PRV2. REVALUATION OF ENDING INVENTORY* Revaluation of Ending Inventory (flag 'Revaluate material'set):Price/exchange rate differences are posted to Inventory AccountBSX. Price control is changed from 'S' to 'V' because inventoryis now valuated at actual price.PRY PRV KDM KDV -> BSX* No revaluation of Ending Inventory (flag 'Revaluate material notset): Price/exchange rate differences are posted to stastisticalaccount LKW. Price control is not changed, because inventoryremains valuated at standard price.PRY PRV KDM KDV -> LKWThe ending inventory posting is reversed immediately in the next period. For this inverse posting a separate accounting document is created with the first day of following period as posting date.So in the next period the inventory continues to be valuated at standard price (until closing of next period).If the standard price was changed in next period, the inverse posting includes a posting to revaluation account (UMB) to clear the revaluation from price change.Postings for beginning of next period:* Revaluation of Ending InventoryBSX -> PRY PRV KDM KDV UMB* No revaluation of Ending InventoryLKW -> PRY PRV KDM KDV UMB3. REVALUATION OF CONSUMPTION* Revaluation of Original Account:Price/exchange rate differences are posted to the same consumption account that was debited by the original goods issue. ( Optionally the CO account assignment of the original goods issue can berevaluated too.)PRY PRV KDM KDV -> Original account* Revaluation of Collective Account:Price/exchange rate differences are posted to a collective accountCOC.PRY PRV KDM KDV -> COC4. REVALUATION OF WORK IN PROCESS (WIP)* Build-up of new WIP (material):PRY PRV KDM KDV -> WPM* Build-up of new WIP (activity/business process):GBB(AUI) -> WPA* Reduction of old WIP (material):WPM -> PRM* Reduction of old WIP (activity/business process):WPA -> PRA________________________________________________________________________Valid releasesSoftware Component Releasefrom toSAP_APPL SAP Application46C - 500________________________________________________________________________Reference to related Notes。