What are the limits for MLT of raw materials and finished products?

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The limits for Microbial Limit Test (MLT) for raw materials and finished products are defined based on the product category and regulatory requirements, such as those from pharmacopeias like the United States Pharmacopeia (USP), European Pharmacopoeia (Ph.Eur.), or Indian Pharmacopoeia (IP).

๐‹๐ข๐ฆ๐ข๐ญ๐ฌ
*For FP/RM
For TAMC-NMT 1000 CFU/g For TYMC-NMT 100 CFU/g
*For FP Liquid products
For TAMC-NMT 100 CFUL For TYMC-NMT 10 CFU/mL

๐€๐›๐ฌ๐ž๐ง๐œ๐ž ๐จ๐Ÿ ๐’๐ฉ๐ž๐œ๐ข๐Ÿ๐ข๐œ ๐ฉ๐š๐ญ๐ก๐จ๐ ๐ž๐ง๐ฌ
๐„. ๐™˜๐™ค๐™ก๐™ž: Absent in 1g or 1mL
๐’๐š๐ฅ๐ฆ๐จ๐ง๐ž๐ฅ๐ฅ๐š: Absent in 10g or 10mL
๐๐ฌ๐ž๐ฎ๐๐จ๐ฆ๐จ๐ง๐š๐ฌ ๐š๐ž๐ซ๐ฎ๐ ๐ข๐ง๐จ๐ฌ๐š: Absent in 1g or 1mL
๐’๐ญ๐š๐ฉ๐ก๐ฒ๐ฅ๐จ๐œ๐จ๐œ๐œ๐ฎ๐ฌ ๐š๐ฎ๐ซ๐ž๐ฎ๐ฌ: Absent in 1g or 1mL

All tests are performed based on the specifications.

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