USP Microbiology Testing
We Are Your USP Microbiology Testing Partner
The FDA requires supplement testing methods that are scientifically valid, with a recorded demonstration of validity. Eurofins BioPharma Product Testing in Canada offers the complete suite of USP testing, conducted directly according to the official USP methods as written.
What is USP?
- USP is the United States Pharmacopeia. It is a set of reference standards and methods that are tied to monographs for specific materials including dietary supplements, botanicals, and pharmaceutical drug products.
- Per USP: “The role of USP in Microbiology is to develop public standards pertaining to microbiology that, along with other requirements, ensure consistent quality of products – dosage forms, drug substances, excipients, food ingredients, and dietary supplements.”
When is USP Testing Necessary?
- USP testing is necessary because microbiology methods need to be validated to show that the test conducted is appropriate for the product being tested and would recover the organism of interest if it were present. When the product is not a food product and falls into the category of dietary supplement, botanical, or drug product, then USP offers specific methods to use for this product type. The methods include a suitability/preparatory test, which serves to verify that the method is appropriate for the product.
Services & the Organisms We Screen
- USP 61 – TAMC, TYMC
- USP 2021 – TAMC, TYMC, Bile Tolerant Gram-Negative (Enterobacteriaceae)
- USP 62 – Bile Tolerant Gram-Negative (Enterobacteriaceae), Salmonella, P. aeruginosa, S. aureus, C. albicans, E. coli, Clostridium
- USP 2022 – Salmonella, S. Aureus, E. coli, Clostridium
- USP 60 – Burkholderia cepacia
- USP 51 – Antimicrobial Effectiveness
Suitability Testing: The Extra Step for Accurate Testing
We offer suitability testing that complies with all FDA requirements and ensures accurate results, following USP microbiological test methods.
- This testing is required on the initial submission of each unique formulation/product submitted.
- Suitability testing provides evidence that the organism or organisms of interest would be detected in the presence of your product matrix through the recovery of a low-level inoculum of the target organism.
- This inoculation and recovery of the target organism provides evidence of the test method's validity and decreases the chance of false negatives.
- The title for the testing is slightly different depending on the method selected – USP <61>/<62> testing of non-sterile products is referred to as suitability testing, while USP <2021>/<2022> testing for dietary supplements is referred to as preparatory testing.
Innovation, individualized service, and a commitment to the highest standards of microbiology testing.
Looking for GMP Compliant Microbiology Testing? We got you covered.
Industries We Serve
- Non-sterile and sterile drugs
- Medicated Animal Feed and Animal Health Products
- Dietary Supplements and Natural Health Products
- Cannabis Products
- Psychedelic Drugs
- Cosmetics & Personal Care Products
- Dental products
- Processed and Purified Water