USP <2023>, Microbiological Attributes of Nonsterile Dietary Supplements
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
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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.
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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 |
Material |
Recommended Microbial Limit Requirements
(cfu/g or mL) |
Other raw materials and dietary supplement ingredients |
Total Aerobic Microbial Count NMT 103 |
Total Combined Yeast & Mold Count NMT 102 |
Absence of E. coli in 10 g |
Nutritional supplements with synthetic or highly refined ingredients |
Total Aerobic Microbial Count NMT 103 |
Total Combined Yeast & Mold Count NMT 102 |
Absence of E. coli in 10 g |
|
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