USP <2021>, Microbial Enumeration Test
For non-sterile botanical and dietary supplement powders, capsules, and liquids, the following tests are required as stated by USP <2021>:
- Total Aerobic Microbial Count (TAMC)
- Total Yeast and Mold Count (TYMC)
- Absence of Gram-Negative Bacteria
USP <2022>, Absence of Specified Microorganisms
Good Manufacturing Practices (GMP) requires objectionable organisms be absent from nutritional and dietary supplement products as per USP <2022>.
- Absence of Escherichia coli
- Absence of Salmonella species
- Absence of Staphylococcus aureus
- Absence of Clostridium species
Retests can be performed to confirm doubtful results by making allowances with a larger sample size.
USP <2023>, Microbiological Attributes of Nonsterile Dietary Supplements
The recommended maximum, allowable acceptable microbial limits for dietary supplement ingredients and products according to USP <2023> are as follows:
Recommended Microbial Limits for Dietary Supplement Ingredients and Products