CEI-MS-15 — references

§7References

§7.1Normative references

The following are normative for this standard: compliance with the standard requires compliance with them^[1,2,3,4].

• ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories — ISO/IEC Standard, 2017
• General Chapter ⟨1225⟩ Validation of Compendial Procedures — United States Pharmacopeia — National Formulary (USP–NF), 2024
• ICH Q2(R2) Validation of Analytical Procedures — ICH Harmonised Guideline, 2023
• WHO Expert Committee on Specifications for Pharmaceutical Preparations — Fifty-seventh report — WHO Technical Report Series, 2023

§7.2Informative references

The following are informative: they support the reasoning of the standard without being conditions of compliance^[5].

• Quality of peptide products obtained from unregulated online suppliers: an analytical survey — Journal of Pharmaceutical Sciences, 2024

§7.3Related standards

• CEI-MS-14 — Certificate-of-analysis minimum data standard for synthetic peptide preparations

Numbered reference list

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
2. 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
3. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q2(R2) Validation of Analytical Procedures. ICH Harmonised Guideline 2023;Step 4 version, 1 November 2023. identifier not held by the Institute
4. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations — Fifty-seventh report. WHO Technical Report Series 2023;No. 1044. identifier not held by the Institute
5. Bhattacharyya S, Wang J, Kaplan RM. Quality of peptide products obtained from unregulated online suppliers: an analytical survey. Journal of Pharmaceutical Sciences 2024;113(4):1102–1110. doi:10.1016/j.xphs.2023.11.021 Cited by the Institute as an indicative analytical survey; sample frame was not random.

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.