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).
Limits
*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
Absence of Specific pathogens
E. ๐๐ค๐ก๐: Absent in 1g or 1mL
Salmonella: Absent in 10g or 10mL
Pseudomonas aeruginosa: Absent in 1g or 1mL
Staphylococcus aureus: Absent in 1g or 1mL
All tests are performed based on the specifications.
