2014年5月29日 · Acceptance criteria for nonsterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC) are given in Tables 1 and 2. Acceptance criteria are based on individual results or on the average of replicate counts when replicate counts are performed (e.g., direct plating methods).

FDA 建议制药商使用 USP 的总需氧 微生物计数 （TAMC）检测或酵母和霉菌总计数（TYMC）检测来评估成品固体剂型的微生物质量。 允许进行其它检测，包括快速 微生物学方法，但制药商必须证明其对药典方法的适用性和等效性。 如果已批准药品的产品规格与指南中的建议不一致 , FDA 不希望申请持有人修改他们的产品规格。 但是，如果新的补充申请提出增加新的生产工艺或放宽某些 工艺参数 , FDA“可以要求申请持有人在审评期间和批准前更新产品规格中的微生物检测信 …

非无菌制剂的细菌数（tamc）和霉菌酵母菌总数（tymc）可接受标准见表5.1.4-1和表5.1.4-2。 可接受标准是基于单个计算结果或多个计数（例如碟式直接计数法）结果的平均值。

aerobic microbial count (TAMC) and the total combined yeasts/moulds count (TYMC) are given in Tables 5.1.4.-1 and 5.1.4.-2. Acceptance criteria are based on individual results or on the average of replicate counts when replicate counts are performed (e.g. direct plating methods). When an acceptance criterion for microbiological quality is

Acceptance criteria for nonsterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC) are given in Tables 1 and 2. Acceptance criteria are based on individual results or on the average of replicate counts when replicate counts are performed (e.g., direct plating methods).

usp 测试方法是对产品进行完整的定量分析，以检测样品中存在的需氧微生物总数 (tamc) 以及酵母和霉菌总数 (tymc)。 该测试方法还包括使用特定微生物的中和和回收率验证。

icroorganisms 62 . Acceptance criteria for nonsterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC) are given.

2015年11月22日 · Total Aerobic Microbial Count是什么意思Total Aerobic Microbial Count 好氧微生物总数检查法；总好氧微生物计数；需氧微生物的总数例句筛选1.Microorganism Preparation of Total Aerobic Microbial Total Yeasts

Our ready-to-use TAMC and TYMC media range comprises: in 500 g and 5 Kg pack sizes for the determination of the total aerobic cell count (Tryptic Soy agar) and of total yeast and mold counts (Sabouraud 4% Dextrose agar). Our Milliflex Oasis ® Platform is a complete solution for bioburden testing.

方法:采用微生物限度检查法检查10 种共100批中药饮片样品的需氧菌总数(TAMC)、霉菌和酵母菌总数(TYMC)、耐热菌数(NAIRE)、耐胆盐革兰氏阴性菌及其他6 种致病控制菌负载量。 结果:100 批饮片样品的lgTAMC 值为2.0~6.8,lgTYMC 值为1.0~6.0,lgNAIRE 值为1.0~5.9,耐热菌检出率为100%,耐胆盐革兰氏阴性菌检出率为27%,2 批当归饮片样品中检出了大肠埃希菌,但所有饮片样品均未检出沙门菌、志贺氏菌、溶血性链球菌、金黄色葡萄球菌和铜绿假单胞菌。 结论:北京地区 …