<61>MICROBIALLIMITTESTS……2503微生物限度检查法 <71>STERILITYTESTS……2508无菌检查法 Biologicaltestsandassays生物检查法与测定法 <81>ANTIBIOTICS—MICROBIALASSAYS……2513抗生素-微生物测定 <85>BACTERIALENDOTOXINSTEST……2521细菌内毒素检查法 <87>BIOLOGICALREACTIVITYTESTS,INVITRO……2525体外的生物反应性检查法 ...
优·USP 通用章节目录.doc,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 App
<61>MICROBIAL LIMIT TESTS……2503微生物限度检查法 <71>STERILITY TESTS……2508无菌检查法 Biological tests and assays生物检查法与测定法 <81>ANTIBIOTICS—MICROBIAL ASSAYS……2513抗生素-微生物测定 <85>BACTERIAL ENDOTOXINS TEST……2521细菌内毒素检查法 <87>BIOLOGICAL REACTIVITY TESTS, IN VITRO……2525体外...
Verification of microbiological procedures is not covered in this chapter because it is covered in USP general chapters?Antimicrobial Effectiveness?51,?Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests?61,?Microbiological Examination of Nonsterile Products: Tests for Specified ...
<61>MICROBIAL LIMIT TESTS……2503微生物限度检查法 <71>STERILITY TESTS……2508无菌检查法 Biological tests and assays生物检查法与测定法 <81>ANTIBIOTICS—MICROBIAL ASSAYS……2513抗生素-微生物测定 <85>BACTERIAL ENDOTOXINS TEST……2521细菌内毒素检查法 <87>BIOLOGICAL REACTIVITY TESTS, IN VITRO……2525体外...
This chapter is not intended for retroactive application to already successfully established laboratory procedures. The chapterValidationof Compendial Procedures <1225>provides general information oncharacteristicsthatshould be consid 3、eredforvarioustestcategoriesandon the documentation that should accompany ...
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 that is sterilized ...
Injectionmeetstherequirementssetforthforsmall-volume Injectionswherethecontainerislabeledascontaining100Topicallyapplieddrugproductsfallintotwogeneralcate- mLorless,iftheindividualmonographstatesatestforgories:thoseappliedtoachievelocalactionandthoseap- ParticulateMatterinInjections788;itmeetstherequire-pliedtoach...
<61>MICROBIAL LIMIT TESTS……2503 微生物限度检查法 <71>STERILITY TESTS……2508 无菌检查法 Biological tests and assays 生物检查法与测定法 <81>ANTIBIOTICS—MICROBIAL ASSAYS……2513 抗生素-微生物测定 <85>BACTERIAL ENDOTOXINS TEST……2521 细菌内毒素检查法 <87>BIOLOGICAL REACTIVITY TESTS,...
<61>MICROBIAL LIMIT TESTS……2503 微生物限度检查法 <71>STERILITY TESTS……2508 无菌检查法 Biological tests and assays 生物检查法与测定法 <81>ANTIBIOTICS—MICROBIAL ASSAYS……2513 抗生素-微生物测定 <85>BACTERIAL ENDOTOXINS TEST……2521 细菌内毒素检查法 <87>BIOLOGICAL REACTIVITY TESTS,...