Nutritional and Dietary Supplement Microbiology Testing

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

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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