What We Test

Under 21 CFR Part 111, dietary supplement manufacturers are responsible for establishing and meeting specifications for identity, purity, strength, and composition. Prodigy Labs provides the analytical data you need to satisfy those requirements — all under one ISO 17025-accredited roof.

21 CFR Part 111 — What the FDA requires: Dietary supplement CGMPs require testing of every raw material component for identity and testing of the finished batch for identity, purity, strength, and composition before releasing to market. Third-party testing from an accredited lab is the most defensible approach to demonstrating compliance.
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HPLC-UV • LC-MS

Potency & Identity

Quantitative potency (active ingredient concentration) and qualitative identity confirmation by chromatographic fingerprinting. Methods are validated for common botanicals, vitamins, amino acids, and specialty actives. Results reported in mg/serving or %DV.

Contact us for method availability on your specific ingredient.
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ICP-MS

Heavy Metals

Quantitative detection of lead (Pb), cadmium (Cd), arsenic (As), and mercury (Hg) by inductively coupled plasma mass spectrometry. Results compared to California Prop 65, USP <232>/<233>, and NSF 173 limits as applicable.

Learn more about ICP-MS →
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Py-GC/MS

Microplastics

Pyrolysis GC/MS detection and quantification of plastic polymer particles in supplement matrices. A growing concern for encapsulated and powder products — particularly those with plastic-adjacent packaging or processing equipment. First and only accredited test of its kind in San Diego.

Learn more about Py-GC/MS →
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GC-FID • USP <467>

Residual Solvents

Detection of residual organic solvents (Class 1, 2, and 3) retained from extraction or manufacturing. Tested per USP <467> with GC-FID. Critical for botanical extract concentrates, softgels with solvent-extracted oils, and ingredients manufactured by chemical synthesis.

Learn more about residual solvents →
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USP <61> / <62>

Microbial Limits

Total aerobic microbial count (TAMC), total combined yeasts/molds count (TYMC), and absence testing for specified organisms (E. coli, Salmonella, S. aureus, P. aeruginosa) per USP <61> and <62>. Performed via qualified partner laboratory with full chain of custody.

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LAL Method • USP <85>

Endotoxin

Kinetic turbidimetric LAL endotoxin testing for injectable-grade supplement ingredients and parenteral applications. Required for amino acids, vitamins, or botanical extracts destined for compounded injection formulations under USP <797>.

Learn more about endotoxin testing →

Who We Test For

From pre-launch brands to high-volume contract manufacturers, we scale to your testing cadence.

Supplement Brands

Pre-launch lot release testing and ongoing batch surveillance for finished products. We work with DTC brands, subscription box companies, and multi-channel retailers who need a defensible COA and the ISO 17025 accreditation statement their retail partners require. Single sample or standing purchase order — both are welcome.

Contract Manufacturers

Release testing for finished goods produced on behalf of brand clients. We can work directly from your internal spec sheets or help you establish specifications where none exist. COAs are formatted for integration into your batch record system. Volume pricing available for high-throughput accounts.

Amazon & Retailer Compliance

Amazon's Dietary Supplement Program requires a COA from an ISO 17025-accredited lab within the last 12 months. Whole Foods, Target, and Walmart have similar requirements with varying scope. We format COAs to satisfy retailer documentation checklists and can reissue reports in alternate formats when required.

Research Institutions

Ingredient and formulation characterization for academic and clinical research. We support bioavailability study preparations, intervention food analysis, and raw material qualification for clinical trial supply chains. Reporting aligned to publication requirements upon request.

Why ISO 17025 Accreditation Matters

What ISO 17025 Means

ISO/IEC 17025 is the international standard for testing and calibration laboratory competence. Accreditation by an ILAC-recognized body (such as A2LA or PJLA) means a third-party auditor has independently verified that our:

  • Personnel are qualified and trained to perform each test in the accredited scope
  • Methods are validated and traceable to national or international measurement standards
  • Equipment is calibrated and maintained per documented schedules
  • Measurement uncertainty is calculated and reported
  • Quality management system ensures consistent, reproducible results
  • Proficiency testing demonstrates ongoing inter-laboratory comparability

Only tests within the accredited scope carry the accreditation statement. We are transparent about which methods are accredited and which are non-accredited but validated.

View our accreditation scope →

What It Means for Your Product

A COA from an ISO 17025-accredited lab is more than a piece of paper — it is a legally credible, technically defensible record of your product's quality.

  • FDA-defensible: If the FDA inspects your facility or requests records, ISO 17025 COAs demonstrate due diligence under 21 CFR Part 111
  • Retailer-accepted: Amazon, Whole Foods, Target, and Walmart all require ISO 17025-accredited third-party testing for supplement listings
  • Legally credible: Accredited results are admissible and credible in product liability disputes and regulatory actions
  • Publication-citable: Research using our data can cite our accreditation and methodology in peer-reviewed publications
  • Consumer-trusted: Prodigy Verified badges powered by ISO 17025 COAs give consumers verifiable proof of quality
Not all third-party labs are equal. Many supplement COAs come from non-accredited laboratories or labs with limited-scope accreditation that does not cover the methods listed on the report. Always verify that the accreditation number and scope on the COA matches the tests performed.
Prodigy Verified Program

Turn Your COA Into a Consumer Trust Signal

Brands tested by Prodigy Labs are eligible to enroll in Prodigy Verified — a consumer-facing product verification platform that lets your customers confirm exactly what testing was performed and what the results showed. Third-party verified. Publicly accessible. No marketing spin.

Learn About Prodigy Verified →

Frequently Asked Questions

What tests are required for dietary supplements?

FDA regulations under 21 CFR Part 111 (CGMPs for dietary supplements) require identity, purity, strength, and composition testing for finished products and incoming raw materials. While the FDA does not mandate a specific test menu, common testing includes identity/potency (HPLC), heavy metals (ICP-MS), microbial limits, and residual solvents.

How do I get my supplement third-party tested?

Submit a sample to an ISO 17025-accredited laboratory with a clear test request specifying the analytes, regulatory standards, and reporting format you need. The lab will provide a Certificate of Analysis (COA) with results, method references, and the lab's accreditation statement.

What should a supplement COA include?

A complete supplement COA should include: sample identification and lot number, test methods (by name and standard reference), results with units and reporting limits, pass/fail criteria, analyst signature, and the laboratory's ISO 17025 accreditation scope statement and accreditation number.

Which retailers require third-party supplement testing?

Amazon's Dietary Supplement Program, Whole Foods Market, Target, and Walmart all have vendor requirements that include third-party testing documentation from ISO 17025-accredited labs. Requirements vary by retailer and product category — contact us to discuss retailer-specific COA formatting.

How much does supplement testing cost?

Supplement testing costs depend on the test panel, matrix complexity, and turnaround time. A standard potency + identity panel runs $300–$600 per sample. Full compliance panels (potency, heavy metals, microbiology, solvents) typically range from $800–$1,800 per sample. Contact us for a quote based on your specific requirements.

Ready to Get Your COA?

Submit your sample request and receive a quote within one business day. Our team will confirm method applicability, turnaround, and pricing for your specific matrix.

Related Testing Services

Supplement testing panels are often combined with the following services.