Approved drug vs research peptide.
The same molecule can come as an approved pen, a compounded vial or a research-market powder. Each comes with different information and different oversight.
- Semaglutide, tirzepatide, tesamorelin and PT-141 (Vyleesi) are FDA approved. BPC-157, TB-500 and retatrutide are not.
- "Research use only" does not authorize human use.
- The FDA says compounded drugs aren't FDA approved, and it doesn't review them for safety, effectiveness or quality before they're sold.
- FDA found counterfeit Ozempic in the legitimate US supply chain. Real lot numbers alone don't prove a pen is real.
- A useful COA is independent and batch-matched, and checks identity, purity, amount, sterility and endotoxin.
How to read a COA
A certificate of analysis (COA) is a lab report on one batch. Go down it in this order.
- Lot match The batch number must match the actual vial in your hand.
- Third-party lab An independent lab, and confirm the report directly with that lab. A seller's purity claim is not proof.
- Identity by mass spec Mass spectrometry shows the molecule is the one on the label.
- HPLC purity HPLC or UPLC shows impurities. A purity percentage doesn't tell you the amount in milligrams.
- Amount per vial A separate assay estimates the amount in the sampled vial. It does not confirm the dose drawn or product sterility.
- Endotoxin and sterility Injections need both, on the finished product. Chemical purity can't confirm either.
Red flags
- A purity screenshot and nothing else A seller's purity claim is not proof.
- "Research use only" on something sold to inject Research-only labels don't establish medicine-quality manufacture or lawful sale for human use.
- No sterility or endotoxin result For an injection, purity alone can't establish either.
- A COA with gaps FDA found identity, assay, aggregate and endotoxin testing gaps in example TB-500 certificates.
What the FDA has warned about
- Counterfeit pens Counterfeit Ozempic turned up in the legitimate US supply chain.
- Dosing mistakes Compounded-vial mistakes of 5 to 20 times the intended dose.
- Fake labels Fraudulent compounded-product labels and unapproved online products.
- Research-labeled GLP-1s FDA names compounds like survodutide and mazdutide in warnings about research-labeled GLP-1 products of unknown quality.
Next: Lesson 5: How to mix
Information only, not medical advice. Peptifacts does not sell anything and does not link to sellers.