<905>UNIFORMITYOFDOSAGEUNITS(HarmonizedChapter,OfficialApril1,2006)……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>WATERDETERMINATION……2785水测定法 <941>X-RAYDIFFRACTION……2788X光衍射 GeneralInformation通用信息 ...
▲〈1504〉QUALITYATTRIBUTESOFSTARTINGMATERIALSFORTHECHEMICALSYNTHESISOFTHERAPEUTICPEPTIDES 添加以下内容: ▲〈1504〉化学合成法多肽原料药起始物料的质量属性 SCOPE 范围 Thisgeneralchapterisintendedtoproviderecommendationsontheminimumqualityattributesforstartingmaterialsusedinthemanufactureofsynthetictherapeuticpeptides.Because...
They contain no mandatory requirements applicable to any official article unless specifically referenced in General Notices, a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply only to articles that are intended for ...
check for your question in the FAQs?before contacting USP. 辅助信息——在联系USP前请核对FAQ中你们的问题 Topic/Question 话题/问题 Contact 联系 Expert Committee 专家委员会 General Chapter 总章节 Horacio N. Pappa, Ph.D. Senior Scientist and Latin American Liaison 1-301-816-8319 (GC05) General ...
sothereisnoneedformethodrevalidationaftermodifications.ManyusersinthepharmaceuticalfieldexaminethepossibilityofmethodtransferbyusingtheallowedadjustmentsintheUSP/EPmethodasawaytospeedupnewdrugdevelopmentandreducesolventandwastedisposalcost.USPGeneralChapter<621>EPGeneralChapter<2.2.46>ColumnLength±70%±70%ColumnI.D....
5、s 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,凡例中的要求应用于所有 usp 和 nf 公认的(即药典的)药品,也适用于所有 附录。如果专论的要求与凡例或附录要求不同,无论专论是否说明...
USP39 General Chapter <1225> Validation of Compendial Procedures
USP General Chapter Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing