41、cility and engineering controlsCompetent personnelSafe work practicesProper use of appropriate Personal Protective Equipment (PPEPolicies for HD waste segregation and disposalThe chapter is organized into the following main sections:1.Introduction and Scope2.List of Hazardous Drugs3.Types of Exposur ...
<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 ...
This chapter provides methods for assessment of quality attributes for identity, purity, quantity, physical state (integrity) and safety of the bulk purified mRNA drug substance, as listed in Table 1 below. These methods can also be applied for drug product following extraction of the mRNA from ...
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 ＜...
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 ＜...
Chapter, Official April 1,2006).2671崩解时限(协调的章节,法定日期,2006.4.1)711DISSOLUTION2673 溶出度*711Dissolution (Harmonized Chapter, Official April 1,2006).2675 溶出度(协调的章节,法定日期,2006.4.1)721DISTILLING RANGE2682馏程724DRUG RELEASE2682药物释放度*724Drug releasee (Harmonized Chapter, ...
USP mRNA V疫苗章节 mRNA 疫苗分析方法规程.pdf,USP mRNA Vaccine Chapter XXX ANALYTICAL PROCEDURES FOR mRNA VACCINES For decades, messenger RNA (mRNA) technology has been explored for vaccines for infectious diseases like flu, Zika, rabies, and cytomegalo
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抑菌WFI Bacteriostatic Water for Injection 抑菌注射用水 NOTE—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes 〈1231〉.注释—关于微生物指标，参见基本资料章节制药用水（1231）。» Bacteriostatic Water for Injection is prepared from Water for Injection ...
chapter except dr y the plate at mum reproducibility of 0 1 mV see pH 791 and equipped 80 for 30 min spray with Spray reagent and heat at 80 with an electrode system consisting of a lead specific electrode for 30 min Examine the plate under white light and a silver silver chloride ...