<905>UNIFORMITY OF DOSAGE UNITS(Harmonized Chapter, Official April 1,2006)……2780制剂单位的含量均匀度(协调的章节2006.4.1) <911>VISCOSITY……2785粘度 <921>WATER DETERMINATION……2785水测定法 <941>X-RAY DIFFRACTION……2788X光衍射 General Information通用信息 <1010>ANALYTICAL DATA—INTERPRETATION AND ...
《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中,所有的通则都是强制执行的吗? 回答: 在USP37-NF32 第二增补本的凡例(General Notice)中“2.OFFICIAL STATUS AND LEGAL RECOGNITION”项下有如下规定: “2.10. Official Text Official te...
1、USP29-通用章节指导目录(附录)第2页 共7页8通用章节指导Guide to General Chapters目录中此颜色并且带有“ * ”的为新增内容General Requirements for Test and Assays 检查与含量分析的一般要求V 1 INJECTIONS 2455 注射剂V 11 USP REFERENCE STANDARDS 2458 USP 对照品Apparatus for Test and Assays 用于检查...
2525 体外的生物反应性检查法USP 通用章节目录 USP29-通用章节指导目录(附录) 第2页 共 7页2 USP29-通用章节指导目录(附录) Gui de t o General Chapter s 通用章节指导目录中此颜色并且带有―***‖浦廷典炮滔暇婶团橡将儡狼肥殃诬哥库浮武浊盲唐栈柄晋羡徊坯悼厌隅穴护狰叔搔阴赡闸迈吏另沿鲁导...
The USP Parenteral Products-Industrial Expert Committee (PPI EC) has worked during the past three revision cycles to revise USP General Chapter Elastomeric Closures for Injection (381). This Stimuli article summarizes these efforts and in the Appendix provides an overview of the current draft revision...
anintegralsystemthatcanbeevaluatedassuch.Systemsuitabilitytestparameterstobeestablishedforaparticularproceduredependonthetypeofprocedurebeingevaluated.Theyareespeciallyimportantinthecaseofchromatographicprocedures.SubmissionstotheUSPshouldmakenoteoftherequirementsundertheSystemSuitabilitysectioninthegeneraltestchapterChromatography...
human-andanimal-derivedaminoacidsshouldbeavoided.Ifuseofaminoacidsofanimalorigincannotbeavoided,therespectivematerialshouldmeettherequirementsoftheEuropeanPharmacopoeiageneralchapter5.2.8.MinimisingtheRiskofTransmittingAnimalSpongiformEncephalopathyAgentsViaHumanandVeterinaryMedicinalProducts.TherequirementforBSE/TSE-free...
GeneralRequirementsforTestandAssays 检查与含量分析的一般要求 <1>INJECTIONS……2455 注射剂 <11>USPREFERENCESTANDARDS……2458 USP对照品 ApparatusforTestandAssays 用于检查与含量分析的器具 <16>AUTOMATEDMETHODSOFANALYSIS……2491 自动化分析方法 <21>THERMOMETERS……2497 温度计 ...
USP General Chapter Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing