(1 g or 1 mL) Total Aerobic Microbial Count (cfu/g Total Combined Yeasts/Molds Count Route of Administration or cfu/mL) (cfu/g or cfu/mL) Specied Microorganism(s) Absence of Candida albicans (1 g or 1 mL) Transdermal patches (limits for one 102 101 Absence of Staphylococcus aureus (...
(1 g or 1 mL) Total Aerobic Microbial Count (cfu/g Total Combined Yeasts/Molds Count Route of Administration or cfu/mL) (cfu/g or cfu/mL) Specied Microorganism(s) Absence of Candida albicans (1 g or 1 mL) Transdermal patches (limits for one 102 101 Absence of Staphylococcus aureus (...
<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 <88>BIOLOGICALREACTIVITYTESTS,INVIVO……2526体内的生物反应性检查法
MicrobialMicrobialYeasts/MoldsYeasts/Molds CountCount总CountCount总酵母 有氧菌计菌和霉菌计数 数 (cfu/gor (cfu/gorcfu/mL) cfu/mL) Nonaquesouspreparationsfor103103AbsenceofEscherichiacoli oraluse(1gor1mL) 口服非水性制剂口服非水性制剂103103大肠杆菌不得检出(1g或1ml) ...
Microbial Limits 微生物限度 Microbial examination of nonsterile drug products is performed according to the methods given in Microbial Enumeration Tests<61>and Tests for Specified Microorganisms<62>, unless the formulation itself is demonstrated to have antimicrobial properties. Acceptance criteria for non...
最大可接受计数2000tableacceptancecriteriamicrobiologicalqualitynonsteriledosageformsrouteadministration摄入途径totalaerobicmicrobialcountcfumltotalcombinedyeastsmoldscount总酵母菌和霉菌计数cfugcfumlspecifiedmicroorganisms控制菌nonaquesouspreparationsoraluse10escherichiacoli1gml口服非水性制剂10大肠杆蘭不得检出1g或1mlaqueous...
—103cfu:最大可接受计数=2000Table1.AcceptanceCriteriaicrobiologicalQualityofNonsterileDosages表1非无菌制剂微生物质量可接受标准RouteofAdministration摄入途径TotalAerobicMicrobialCount总有氧菌计数(cfu/gorcfu/mL)TotalCombinedYeasts/MoldsCount总酵母菌和霉菌计数(cfu/gorcfu/mL)SpecifiedMicroorganism(s)控制菌Nona...
04USP-EP统合微生物限度检查法详解-陈影影
In addition it should reference General Chapter <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use, to assist the pharmacists in setting meaningful microbial limits for nonsterile products. Response: Comment not ...
17 <61>Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 非无菌产品...