<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 ...
sothereisnoneedformethodrevalidationaftermodifications.ManyusersinthepharmaceuticalfieldexaminethepossibilityofmethodtransferbyusingtheallowedadjustmentsintheUSP/EPmethodasawaytospeedupnewdrugdevelopmentandreducesolventandwastedisposalcost.USPGeneralChapter<621>EPGeneralChapter<2.2.46>ColumnLength±70%±70%ColumnI.D....
In the GeneralChapter, USP also emphasises that the "idea that a temperatureexcursion above a product's storage temperature can be 'fixed' just by loweringthe temperature of a warehouse for an appropriate period of time so that theresulting MKT calculation would provide an acceptable value" is n...
USP39 General Chapter <1225> Validation of Compendial Procedures
USP General Chapter Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
14页 顶/踩数: 0/0 收藏人数: 5 评论次数: 0 文档热度: 文档分类: 待分类 系统标签: index加亮chapter认领testsgeneral <861>Sutures---Diameter<871>Sutures---NeedleAttachment<691>Cotton<1151>PharmaceuticalDosageForms<1196>PharmacopeialHarmonization<1225>ValidationofCompendialProcedures[Note:ThisTableandthech...
《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...
a new USP General Chapter for the control of inorganic impurities in drug and dietary supplement articles intended for use in humans. For the purposes of this article, inorganic impurity, metal, and element all refer to those elements listed in Table 1. The proposed new General Chapter ...