Third-party testing for dietary supplement brands
FDA’s dietary supplement cGMP rule, 21 CFR Part 111, requires identity testing of dietary ingredients and finished-product specifications that are verified by testing. We run those tests on an instrument bench we own, publish the certificate, and give you a QR code for the label.
What a finished product needs
| Test | Method | What it answers |
|---|---|---|
| Identity of active ingredients | MethodLC-MS/MS accurate mass; HPTLC or microscopy for botanicals | What it answersIs the declared ingredient present? |
| Label claim (potency) | MethodHPLC-UV or LC-MS/MS against a certified reference standard | What it answersHow many milligrams per serving, and what percent of label? |
| Heavy metals | MethodICP-MS after closed-vessel digestion: Pb, As, Cd, Hg, plus Ni and Cr | What it answersDoes it meet USP <2232> and California Proposition 65 levels? |
| Microbial limits | MethodUSP <2021>/<2022>: aerobic count, yeast and mould, E. coli, Salmonella, S. aureus | What it answersIs it fit for oral consumption? |
| Pesticide residues | MethodLC-MS/MS and GC-MS multi-residue on botanical ingredients | What it answersAre agricultural residues under limits? |
| Undeclared drugs | MethodLC-MS/MS screen for fentanyl and analogs; targeted screens on request | What it answersIs there anything in it that should not be? |
Prices
Supplement testing starts at $119 per sample for a single-active label claim and identity. Heavy metals add $169, microbial limits $239, pesticide residues $205, fentanyl and analog screen $89. Multi-active products price per active. The intake builder shows the total before payment and the same total appears on the invoice.
Why brands use us
- Every certificate is public by accession number, so a retailer, a marketplace or a customer can check it without asking you for a PDF.
- Certificates carry your branding, a QR code and a SHA-256 hash, and publish to WooCommerce product pages automatically through the plugin.
- Chain-of-custody video from carrier scan to certificate, retained three years, answers the question a retailer’s QA team asks first.
- We sell no supplements and take no vendor payment for outcomes. Failures publish on the same day as passes.
- Methods, instrument IDs and specifications are on the certificate line, which is what a 21 CFR 111 auditor wants to see in your batch record.
Accreditation, stated plainly
We operate to ISO/IEC 17025 expectations and are not accredited. Some retailer programs and some state rules require an accredited laboratory for specific tests; check the requirement before relying on any laboratory. Our calibration records, SOPs and method references are public on the quality page, and SOPs are available under NDA for supplier qualification.
Questions
Does 21 CFR Part 111 require third-party testing?
It requires that identity of each dietary ingredient be verified by testing and that finished-product specifications be met, with testing or examination to confirm it. The rule does not require that an outside laboratory do the work, but an independent certificate is what retailers and marketplaces ask for and what defends a batch record in an inspection.
How much product do you need?
Capsules and tablets: 30 units. Powders: 50 g. Liquids: two retail units. Gummies: 30. Add material for each contaminant panel; the intake builder totals it.
Can you test to my own specification?
Yes. Enter the specification at intake and the certificate reports pass or fail against it, with the method and limit printed on the line.
Do you offer stability studies?
Real-time and accelerated stability programs for one SKU are available; they are quoted per protocol at intake.
How do I put the certificate on my product page?
Every certificate has a public URL and QR code. The WooCommerce plugin publishes new certificates to the matching product automatically; other platforms can use the API or the link.
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Submit a sample
An invoice is issued at submission and the prepaid label is emailed when payment lands.