How to verify a peptide in Panama: COA, HPLC and lot

Why a physician in Panama should know how to read a COA

When a patient arrives with a vial of uncertain origin, or a colleague asks what backs a peptide, the only available document is often a certificate of analysis (COA). In Panama that document has a legal definition, but a PDF with charts does not by itself prove that the vial contents match what is written. The World Health Organization defines falsified products as those that "deliberately misrepresent their identity, composition or source" and warns that substandard and falsified products are often sold online or in informal markets⁷. This article, written as evidence and regulation for physicians and for research purposes only, summarizes what to look at. For the full legal framework, see the physician's legal map in Panama.

What Law 419 says about certificates and laboratories

Law 419 of 2024 defines the certificate of analysis (art. 3, item 16) as a "document issued by a national or foreign quality-control laboratory" that backs the product's identity and quality through lot-by-lot analysis¹. Prior quality, safety and efficacy control is in art. 68, and art. 74 sets reference laboratories a limit of no more than 60 business days to perform it¹. The reference laboratories are the Specialized Analysis Institute (IEA) of the University of Panama and the Institute for Scientific Research and High-Technology Services; other laboratories must be accredited by the Ministry of Commerce and Industries and authorized by the Ministry of Health (MINSA) through the National Directorate of Pharmacy and Drugs (DNFD) (arts. 72 and 73)¹.

PAHO describes the IEA as the reference laboratory for quality control of medicines circulating in the national market², and in October 2023 it was supporting documentation of procedures, including validation of analytical methods, with the goal of meeting WHO good practices for quality-control laboratories³. In February 2024 the Technical Medicines Board, MINSA's DNFD, the IEA and INDICASAT were discussing creating a Network of Medicine Quality-Control Laboratories with a good-practice guide⁴. That legal circuit is designed for registered medicines; we found no public procedure for a physician to send an unregistered vial for analysis, and in its August 2026 alert on falsified tirzepatide (lot D881474) the DNFD stated that the falsified product is not registered in Panama⁵. In September 2025 MINSA launched a national campaign against falsified medicines and warned that e-commerce and informal sales make oversight harder⁶. More context in falsified Ozempic and Mounjaro in Panama.

HPLC, molecular weight and content: three different questions

• Purity (HPLC): answers what fraction of the detected material is the target peptide versus its synthesis impurities. For peptides, typical impurities are sequences missing or carrying extra amino acids, and degradation products¹⁷.
• Identity (mass spectrometry): confirms that the molecular weight matches the declared sequence¹¹. High purity of the wrong peptide is still the wrong product.
• Net content: peptide content is defined as the percentage of peptide relative to non-peptide material, mostly counter-ions and moisture, and it is not equivalent to purity¹¹. A vial can be 98% "pure" and still contain less peptide than labeled.
• Validated method: the ICH Q2(R2) guideline offers a general framework for validating analytical procedures⁹. For synthetic peptides, the European Medicines Agency (EMA) guideline on development and manufacture, in force since June 1, 2026, covers characterisation, specifications and analytical control⁸.

A useful COA names the laboratory, the exact lot, the method and the conditions, and can be cross-checked with the issuing laboratory. ISO/IEC 17025 is the competence reference for laboratories, but ISO does not accredit laboratories: independent accreditation bodies do, so it is worth asking who accredited the laboratory and for which tests¹⁰.

What labs found when they tested gray-market peptides

In a 2024 study, six illegal online pharmacies sold semaglutide: three vials arrived and none of the three pens ordered. Measured purity was 7.7% to 14.37% against 99% claimed, content exceeded the label by 28.56% to 38.69%, and endotoxin was detected in all samples¹². In Belgium, analysis of falsified peptides found purities of 5% to 75% in cysteine-containing ones, inorganic arsenic up to ten times the ICH limit for parenterals, and one lead-contaminated sample¹³; the same group documented haemolytic Bacillus cereus in two illegal injectable peptides¹⁴. With growth hormone sold online, 17 vendors shipped product directly, 94% without a prescription, and every sample had less somatropin than labeled¹⁶. A review summarizes falsification of biotechnology drugs as an already present risk¹⁸.

Red flags when reviewing a COA

The following signals are editorial criteria derived from the above, not an official standard:

• No identifiable laboratory, lot or method: the certificate cannot be cross-checked¹.
• Purity without identity: no molecular weight, only a chromatogram¹¹.
• Purity without net content, counter-ion or moisture¹¹. The Belgian study showed that a supplier's certificate can differ widely from independent testing¹⁵.
• Identical charts or figures across different products or doses: may indicate a copied document. Ask the issuing laboratory to confirm the report.
• No verification code, or a client name different from the supplier presenting the report: if the laboratory offers a public registry, the client name should match.
• No traceability between the vial's lot number and the report's: Law 419 defines traceability as the system that follows a medicine from its production¹.

How this connects to sanitary registration

A COA does not replace sanitary registration or turn a research product into a medicine. Law 419 classifies marketing a product without sanitary registration, except where the law itself allows it, as a very serious offense (art. 156)¹, as we detail in the sanitary-registration double standard. For the broader picture of the molecule family, see the peptide universe.