USP <61> | 合法醫療器材資訊網

TheUSP<61>-MicrobialEnumerationsTestisaproductsafetytestfoundinChapter61oftheUnitedStatesPharmacopeia.·TheUSP<61>testissimilartoan ...

The USP <61> – Microbial Enumeration Test is a product safety test found in Chapter 61 of the United States Pharmacopeia.

It is suggested for use by the FDA for pharmaceuticals as well as cosmetics and personal care products to ensure that a product’s preparation complies with pre-set specifications for microbiological quality.

The USP <61> test is a full quantitative analysis of a product to determine the Total Aerobic Microbial Count (TAMC[1]) and Total Yeast and Mold Count (TYMC)[2] present in the sample. It also includes a neutralization and recovery validation using specific microorganisms. This ensures that the methods used to determine the presence of these microorganisms are appropriate for each individual product.

Similar to an aerobic plate...

61 MICROBIOLOGICAL EXAMINATION OF ... | 合法醫療器材資訊網

11/21/2016 34(6) Sixth Interim Revision Announcement: 61<61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERA… Read More

62 MICROBIOLOGICAL EXAMINATION OF ... | 合法醫療器材資訊網

Products: Microbial Enumeration Tests 61 ). For a given product, if the antimicrobial activity with respect to a microorganism for which testing is prescribed cannot ... Read More

Change to read | 合法醫療器材資訊網

11/21/2016 33(2) Second Interim Revision Announcement: <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERA… Read More

FAQs | 合法醫療器材資訊網

FAQs: <61> Microbial Examination of Nonsterile Products: Microbial Enumeration Tests · 1. Can I use strains other than those that are cited in the USP? · 2. Is there ... Read More

USP <61> and USP <62> Microbiological Examination of ... | 合法醫療器材資訊網

The USP <61> test provides enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. This test provides the total number of aerobic ... Read More

Microbiological Examination Of Nonsterile Products | 合法醫療器材資訊網

USP 31. Microbiological Tests / 〈61〉 Microbiological Examination. 1. Preparation of Test Strains. 〈61〉 MICROBIOLOGICAL. Use standardized stable ... Read More

USP <61> | 合法醫療器材資訊網

The USP <61> - Microbial Enumerations Test is a product safety test found in Chapter 61 of the United States Pharmacopeia. · The USP <61> test is similar to an ... Read More

Microbial Enumeration for Non | 合法醫療器材資訊網

The USP <61/62> test system uses the compendia method, as set forth by USP, for the testing of nonsterile pharmaceutical products and other nonsterile articles ... Read More

<61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE ... | 合法醫療器材資訊網

由 IJ Pflug 著作 · 2012 — USP 35. Viable Spore Count. D-value determination methods for pa- per carrier biological indicators may be used to calculate the. 〈61〉 MICROBIOLOGICAL. Read More

USP <61> and USP <62> Microbial Tests for Non | 合法醫療器材資訊網

USP <61> is often called a Bioburden or Microbial Limits test. This test determines how many microorganisms are present in non-sterile drug products. Read More

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