<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 ...
Apparatu1and2with1literveelintheUSGeneralTetChapteronDISSOLUTION711〉 andDRUGRELEASE724〉,AARATUSSUITABILITY。Storeinadryplace.Storethetabletat controlledroomtemperaturenotexceeding25°. US泼尼松标准片用于采US中方法1和方法2对1升溶出杯,进行US通用测试部分 ...
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...
sothereisnoneedformethodrevalidationaftermodifications.ManyusersinthepharmaceuticalfieldexaminethepossibilityofmethodtransferbyusingtheallowedadjustmentsintheUSP/EPmethodasawaytospeedupnewdrugdevelopmentandreducesolventandwastedisposalcost.USPGeneralChapter<621>EPGeneralChapter<2.2.46>ColumnLength±70%±70%ColumnI.D....
Guide to General Chapters 通用章节指导 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 ＜1＞INJECTIONS……2455 注射剂 ＜11＞USP REFERENCE STANDARDS……2458 USP对照品 Apparatus for Test and Assays 用于检查与含量分析的器具 ＜...
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。
So far, there is the General Chapter <1207> on the evaluation of the integrity of packaging ...
GENERAL CHAPTERS 通则通则 Each general chapter is assigned a number that appears in brackets adjacent to the chapter name e g Chromatography Articles recognized in these compendia must comply with the official standards and tests and assays in the General Notices relevant monographs and General ...
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 ...
themetalslistedinTable1areimportanttocontrolinfood,dietarysupplements,anddrugarticles.ManytoxicmetalimpuritiesfoundinpharmaceuticalarticleshavebeencontrolledforyearsbyapplicationoftheHeavyMetalstestdescribedinUSP–NFGeneralChapterHeavyMetals<231>.However,theproceduresandthemethodscontainedin<231>lackthesensitivity,...