CEI-MS-14 — Certificate-of-analysis minimum data standard for synthetic peptide preparations
Certificate-of-analysis minimum data standard for synthetic peptide preparations
§1Scope
§1.1Scope
Applies to the documentation accompanying any synthetic peptide preparation. Defines the fields the Institute treats as critical and as recommended, and the basis on which a certificate is recorded as conformant or not conformant in a supplier dossier.
§2Principle
A certificate of analysis is a claim about a specific batch, supported by determinations performed on that batch by a stated method. Its purpose is to allow a recipient to know what is in the container and to reconstruct how that was established. A field is critical where its absence prevents a reader from establishing either identity or quantity; it is recommended where its absence limits interpretation without preventing it.[1,2]
§3Apparatus and reagents
§3.1Apparatus
- Not applicable — this is a documentation standard rather than a laboratory procedure
§3.2Reagents and reference materials
- Not applicable
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
- United States Pharmacopeial Convention. General Chapter ⟨1225⟩ Validation of Compendial Procedures. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.