Lab Testing & Quality

Certificate of Analysis (COA)

At-a-glance comparison

SpecValue
Document typeLab-issued analytical test report for a specific batch
Standard fieldsProduct name, batch / lot number, manufacturing date, lab name, accreditation, test methods, results, acceptance criteria, signature
Typical analyte panel for 7-OH productsMitragynine assay, 7-OH assay, microbial counts (TAC, TYM, E. coli, Salmonella), heavy metals (Pb, Cd, Hg, As), residual solvents per ICH Q3C
Standard analytical methodsHPLC or LC-MS for alkaloid assay; ICP-MS for heavy metals; USP <2021>/<2022> for microbial; GC-MS for residual solvents
Common lab accreditationsISO/IEC 17025; CLIA; AHPA-accredited
Industry-standard referenceUnited States Pharmacopeia (USP); AOAC International; AKA GMP Standards Program

What is a Certificate of Analysis?

A Certificate of Analysis (COA) is a formal document issued by an analytical testing laboratory that summarizes the results of all tests performed on a specific batch or lot of a product. The COA is intended to demonstrate that the batch meets the manufacturer's specifications - and, where applicable, regulatory or industry-program requirements - before that batch is released for sale.

For 7-hydroxymitragynine and kratom products, the COA serves as the principal evidence of product quality. Reputable manufacturers and distributors publish the COA for each batch alongside the product, and laboratories accredited under standards such as ISO/IEC 17025 are typically the issuing authority.

What appears on a complete 7-OH COA?

A complete COA for a 7-hydroxymitragynine or kratom product typically includes the product name and batch or lot number, the manufacturing date and the analysis date, the laboratory name and accreditation, the test methodology used for each analyte, the result of each test, the acceptance criterion the batch was tested against, and the signature of an authorized lab analyst.

The analyte panel for a 7-OH or kratom product generally covers the percent assay of mitragynine and 7-OH (measured by HPLC or LC-MS); microbial counts including total aerobic count, total yeast and mold count, and absence of E. coli and Salmonella; heavy metals (lead, cadmium, mercury, arsenic) by ICP-MS; and residual solvents per the ICH Q3C framework, measured by gas chromatography. Some COAs additionally report identity, moisture content, and stability indicators.

Acceptance criteria and industry standards

Acceptance criteria - the limits each test result must meet for the batch to pass - are typically drawn from United States Pharmacopeia (USP) chapters such as for elemental impurities, / for microbial enumeration, and for botanical raw materials. The International Council for Harmonisation Q3C guideline governs residual solvent classifications and limits. AOAC International publishes validated methods for many of these tests.

The American Kratom Association GMP Standards Program defines additional kratom-specific test panels and acceptance criteria for member vendors. While the AKA program is voluntary, it is currently the most prominent industry-specific quality framework for kratom alkaloid products in the United States.

How to verify a COA is legitimate

A legitimate COA is issued by an independent third-party laboratory, identifies that laboratory by name and accreditation, lists the specific batch or lot number, references defined test methodologies, states acceptance criteria, and is signed or electronically authenticated. Several common warning signs suggest a COA may not be reliable: missing batch numbers, missing methodology, missing acceptance criteria, missing or unverifiable lab name, or COA documents that look identical across multiple batches.

The most reliable verification is to contact the issuing laboratory directly using contact information independently obtained (not the contact information printed on the COA itself) and confirm that the laboratory issued the specific COA in question.

Common questions about certificate of analysis (coa)

What does COA stand for?
COA stands for Certificate of Analysis. It is a formal lab-issued document summarizing the test results for a specific batch of a product.
What should a 7-OH product COA include?
A complete 7-OH product COA should include the product name and batch number, the lab name and accreditation, the test methods used, results for the percent assay of mitragynine and 7-hydroxymitragynine, microbial counts (TAC, TYM, absence of E. coli and Salmonella), heavy metals (Pb, Cd, Hg, As), residual solvents, and an authorized signature.
Who issues the COA?
An independent analytical testing laboratory issues the COA. For credibility, the laboratory should be accredited under a recognized standard such as ISO/IEC 17025.
What method is used to measure 7-OH content on a COA?
Reverse-phase HPLC with ultraviolet or mass-spectrometry detection is the analytical standard. Confirmatory analysis is typically performed by LC-MS.
How do I know a COA is real?
A legitimate COA is issued by a named, accredited third-party laboratory; references a specific batch number; lists test methodologies and acceptance criteria; and bears an authorized signature. The most reliable verification is to contact the issuing laboratory directly using independently obtained contact information.

References

  1. United States Pharmacopeia. (2024). General Chapter Elemental Impurities.
  2. International Council for Harmonisation. (2021). ICH Q3C Residual Solvents Guideline.
  3. American Kratom Association. (2024). AKA GMP Standards Program.

Important safety information:

Products containing 7-hydroxymitragynine (7-OH) are sold for adult use only (21+). These statements have not been evaluated by the U.S. Food and Drug Administration. Products are not intended to diagnose, treat, cure, or prevent any disease. The FDA has raised safety concerns regarding concentrated 7-OH products; consult a qualified healthcare professional before use. Do not operate vehicles or machinery after use. Keep out of reach of children and pets. Laws vary by state, buyers are responsible for knowing applicable law.

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