What Is Certificate of Analysis?
A document issued by a qualified testing laboratory that certifies the identity, purity, potency, and composition of a raw material or finished dietary supplement product, based on laboratory testing results.
Why It Matters for Supplement Brands
COAs are the primary documentation that proves your supplement contains what the label says and doesn't contain what it shouldn't (contaminants, heavy metals, microbes). They're essential for cGMP compliance, retailer requirements, and consumer transparency.
How It Works
A comprehensive COA for a dietary supplement typically includes:
1. **Identity testing**: Confirmation that the ingredient is what it claims to be (e.g., HPLC, mass spectrometry, DNA barcoding for botanicals). 2. **Potency/assay**: Measurement of active compound concentration (e.g., withanolide content in ashwagandha). 3. **Heavy metals**: Testing for lead, mercury, cadmium, and arsenic against USP limits. 4. **Microbiology**: Total plate count, yeast and mould, E. coli, Salmonella, Staphylococcus aureus. 5. **Pesticide residues**: For botanical ingredients. 6. **Solvent residues**: For extracted ingredients. 7. **Allergen testing**: If applicable.
COAs should be obtained from ISO 17025-accredited or equivalent laboratories for maximum credibility.
Common Mistakes to Avoid
- ✗Accepting COAs from suppliers without verifying them through independent third-party testing
- ✗Not checking that the COA lot number matches the actual lot received
- ✗Relying on COAs that only test identity but not potency, purity, or contaminants
- ✗Not retaining COAs for the required cGMP record retention period
Related Terms
See It in Action
Explore how this concept applies to real ingredient substantiation:
Automate Your Substantiation
Nutra Comp turns weeks of manual research into minutes of automated clinical evidence analysis and FDA-compliant claim generation.
Join the Waitlist