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Certificate of analysis (COA)

A certificate of analysis (COA) is a document issued for one batch of a material that lists each test performed on that batch, the acceptance limits for each test and the numerical results obtained. ICH Q7, the good manufacturing practice guidance for active pharmaceutical ingredients published by the U.S. FDA, states that authentic certificates of analysis should be issued for each batch on request.[1]

What does ICH Q7 say a certificate of analysis should contain?

Section 11.4 of ICH Q7 lists the name of the material, its grade where appropriate, the batch number and the date of release. Where the material has an expiry date or a retest date, that date should be given on the label and the certificate.[1]

The same section states that a certificate should list each test performed in accordance with the relevant requirements, including the acceptance limits and the numerical results, and that certificates should be dated and signed by authorized personnel of the quality unit.[1]

Why is a certificate tied to a single batch or lot?

ICH Q7 defines a batch, or lot, as a specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. A certificate reports results for samples drawn from that quantity, which is why it names the batch number.[1]

U.S. labeling rules for in vitro diagnostic products illustrate the same idea: 21 CFR 809.10(a)(9) calls for a control number or lot number on the label, traceable to the production history.[2]

Which kinds of tests does a specification group together?

ICH Q6B defines a specification as a list of tests, references to analytical procedures and acceptance criteria, which are numerical limits, ranges or other criteria for the tests described. For a drug substance it groups tests under appearance and description, identity, purity and impurities, potency and quantity.[3]

ICH Q6B also names endotoxin detection as an example of a pharmacopoeial test that should be performed on a drug substance where appropriate.[3]

What does a numerical result on a certificate establish?

A result is the value an analytical procedure produced on the sample tested. ICH Q2(R2) states that the objective of validating an analytical procedure is to demonstrate that it is fit for the intended purpose, and lists characteristics such as specificity or selectivity, range, accuracy and precision.[4]

ICH Q6B notes that the determination of absolute, as well as relative, purity presents considerable analytical challenges and that the results are highly method dependent. A purity figure is therefore read together with the method that produced it.[3]

How is a PepGenex certificate obtained?

Certificates of analysis are available on request. Include the lot code. The lot code is printed on the vial label. Requests go to info@pepgenex.com. The Research Standards page lists the items each PepGenex certificate reports.

The sterility-related test line on a PepGenex certificate of analysis is Rapid Sterility Screening (PCR), reported as Not Detected. This screening is a detection result for the sample tested and does not by itself establish the sterility of every unit or a validated sterility assurance.

Limitations

A certificate reports only the tests it lists, on the samples tested, by the methods used. It does not report tests that were not performed, and a result for one lot says nothing about another lot.[1]

ICH Q6B states that it does not recommend specific test procedures or specific acceptance criteria. The presence of a test on a certificate does not by itself show that the test method was validated for that material.[3],[4]

This page describes what the cited documents say. It is not a statement that any PepGenex material has been manufactured, tested or released under any of them.

Compound profiles

Research peptide profiles in this library. What this page describes applies to peptide lots in general; none of these profiles reports a result of it for any lot.

References

  1. ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. U.S. FDA guidance for industry, September 2016. FDA docket FDA-1995-D-0288
  2. 21 CFR 809.10, Labeling for in vitro diagnostic products (2025 edition), paragraphs (a)(9) and (c)(2)(i)-(ii). 21 CFR 809.10
  3. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. U.S. FDA guidance for industry, August 1999. FDA docket FDA-1998-D-0003
  4. ICH Q2(R2) Validation of Analytical Procedures. U.S. FDA guidance for industry, March 2024. FDA docket FDA-2022-D-1503