Completeness of certificates of analysis in the research-supply channel
What proportion of certificates of analysis supplied with research peptides contain the fields required to interpret the reported purity figure?
§1Abstract
§1.1Review question
What proportion of certificates of analysis supplied with research peptides contain the fields required to interpret the reported purity figure?
§1.2PICO frame
Table 1. The registered PICO frame. Any change made after protocol registration is recorded in the amendment log at §5 and is identified there as post hoc.
| Element | As registered |
|---|---|
| Population | Certificates of analysis supplied with research-grade peptides through direct-supply channels. |
| Intervention | Not applicable — the unit of analysis is the certificate. |
| Comparator | The Institute’s certificate minimum data standard, CEI-MS-14. |
| Outcomes | Presence of each critical and recommended field; ability to close a mass balance; traceability to a named batch. |
§1.3Method in brief
A review of analytical and quality evidence for a compound or class as supplied, rather than of clinical effect. The protocol was registered with the Institute's secretariat before the search was executed. The search was run on 7 October 2024 across 8 sources and is reproduced in full at §2. Screening, extraction and certainty assessment were performed independently by two members of the secretariat with disagreement resolved by a third.[1,2]
§1.4Conclusion
Moderate certainty evidence from the Institute’s own assessment of the twenty suppliers in its set indicates that a purity percentage is almost always present, that the method producing it is named in a minority of certificates, and that peptide content, water content and counter-ion content are absent often enough that a mass balance cannot be closed for most sampled certificates. A purity figure reported without the method that produced it indicates that chromatography was performed and very little more.
The conclusion rests on 24 contributing studies, listed with their extracted data at §3 and summarised outcome by outcome at §4.
§1.5Limitations
§1.6Consultation
This review was released for public comment before ratification. Draft synthesis: Completeness of certificates of analysis in the research-supply channel received 8 submissions. Amendments arising are recorded in the amendment log and are traceable to a numbered submission.
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.