(医疗药品管理)美国药 典USP 无菌检查 美国药典USP31-NF26 无菌检查法《71》.doc 谢谢阅读 71STERILITYTESTS 无菌检查法 Portionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtex 精品文档放心下载 tsoftheEuropeanPharmacopeiaand/ortheJapanesePharmacopeia.Thoseportion 精品文档放心下载 sthatarenotharmonizedar...
General Noti-ces, the individual monographs, and the General Tests and Assays chapters of this Pharmacopeia.á1004ñ MUCOSAL DRUG PRODUCTS—PERFORMANCE TESTSINTRODUCTIONMucosal drug products deliver drug substances to the body via the mucosal route. For the purposes of this chapter, themucosal route...
usp凡例pharmacopeia药典增补本monograph GeneralNoticesandRequirements凡例ApplyingtoStandards,Tests,Assays,andOtherSpecificationsoftheUnitedStatesPharmacopeia应用于美国药典的标准、测试、定量分析、其他质量标准TheGeneralNoticesandRequirements(hereinafterreferredtoastheGeneralNotices)andgeneralrequirementsappearinginGeneralChapterspro...
usp 溶剂残留 中英文版 <467>溶剂残留 简介:INTRODUCTION This general chapter applies to existing drug substances, excipients, and products. All substances and products are subject to relevant control of solvents likely to be present in a substance or product.本章节适用于现有的原料药,辅料和制剂。
PortionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopeiaand/ortheJapanesePharmacopeia.Thoseportionsthatarenotharmonizedaremarkedwithsymbols()tospecifythisfact.此通则的各部分已经与欧洲药典和/或日本药典的对应部分做了协调。不一致的部分用符号()来标明。Thefollowingproceduresareapplic...
7. How often do I perform the system suitability test in Total Organic Carbon General Chapter ? USP General Chapter intentionally says nothing about how often the system suitability test (SST) should be run. The reasoning is that this frequency depends on the stability of the Total Organic Carb...
USP Announces Monograph Revisions List and Postponed Publication of General Chapter
TESTFORSTERILITYOFTHEPRODUCTTOBEEXAMINED供试产品的无菌检查NumberofArticlestoBeTested供试物品数量Unlessotherwisespecifiedelsewhereinthischapterorintheindividualmonograph,testthenumberofarticlesspecifiedinTable3.Ifthecontentsofeacharticleareofsufficientquantity(seeTable2),theymaybedividedsothatequalappropriateportionsare...
as certain complexes, at certain oxidation states, or in organic combinations. This chapter should be considered a screening method to identify the presence of potentially hazardous elements. Where speciation of an element is important, further testing is necessary. In these cases, the monograph will...
Where the requirements of an individual monograph differ from the General Notices or a general chapter, the monograph requirements apply and supersede the requirements of the General Notices or the general chapter, whether or not the monograph explicitly states the difference. 除另有规定外,凡例中的...