Identity, purity, strength, composition and contaminant testing under 21 CFR 111, plus adulterant screening
Under 21 CFR 111, supplement makers have to set specifications for their ingredients and finished batches and show with testing that the specifications are met. That means confirming the identity of every dietary ingredient, and testing purity, strength, composition and limits on contaminants. We test incoming ingredients and finished products against those specifications, and screen for undeclared drugs that turn up in some weight-loss, sports and sexual enhancement products.
Testing is quoted per product or per specification.
Identity of dietary ingredients by HPLC, LC-MS and GC-MS, compared with reference material. Botanical identity by marker compounds and LC-MS profiles.
Label claim testing for vitamins, minerals, amino acids, botanical marker compounds and other dietary ingredients.
Heavy metals including lead, cadmium, arsenic and mercury (USP 2232 and Prop 65), residual solvents (USP 467), pesticides and mycotoxins.
Total aerobic count, yeast and mold, and absence of specified organisms such as E. coli, Salmonella and Staphylococcus aureus (USP 2021 and 2022).
Disintegration and dissolution (USP 2040), water activity, moisture and other properties in your specification.
Screening for undeclared drugs and banned stimulants. See the section below.
Every lot of a dietary ingredient needs its identity confirmed before use, and you can only rely on a supplier’s certificate for the other specifications if you have qualified that supplier. We can do the full specification testing to qualify a supplier and check their certificate, then test identity on each lot and the full specification again on a schedule you set.
Some supplements, mostly in weight loss, sports performance and sexual enhancement, have been found to contain prescription drugs, banned stimulants or analogs made to slip past testing. We screen for:
Targeted screening on LC-MS/MS covers known compounds at low levels. High-resolution LC-MS is used to look for analogs and related compounds that aren’t on a target list. This screening is useful for brands checking a new co-manufacturer or ingredient supplier, and for retailers and distributors checking what they sell.
Botanical ingredients can be substituted with a cheaper species, diluted, or spiked with a synthetic version of the compound they’re sold for. We compare marker compounds and LC-MS profiles of your material against authenticated reference material, and measure the marker compounds that make up the label claim.
Assays for individual botanicals: turmeric and ginger, ginkgo, ginseng, ashwagandha and boswellia, and echinacea, St. John’s wort, milk thistle and valerian.
Send your specification, or tell us the product and its label.
We quote each test and the sample amount.
Finished units, or raw material in a sealed container.
A report with each result against your specification.
You have to confirm the identity of every dietary ingredient before use, and set and meet specifications for identity, purity, strength, composition and contaminants in the finished product. You choose the tests that show those specifications are met.
For identity of a dietary ingredient, no. You need your own identity test. For other specifications, yes, once you have qualified the supplier by confirming their results.
21 CFR 111 lets you test a representative sample of batches for some specifications, based on a sound statistical plan. Most brands test every batch for identity and microbial limits.
Often, yes. High-resolution LC-MS can flag compounds that look like known drugs but aren’t on the target list. Anything flagged that way is reported as tentative unless it can be confirmed with a reference standard.
Yes. Results can be reported against the daily intake limits Prop 65 uses, based on your serving size.
Tell us about your product and we’ll send back a quote. You can also email [email protected].
