CEI-MS-10 — references

§7References

§7.1Normative references

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

• 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
• ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products — ICH Harmonised Tripartite Guideline, 1999
• General Monograph 2034 Substances for Pharmaceutical Use — European Pharmacopoeia, 2023

§7.2Informative references

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

• Related impurities in peptide medicines — Journal of Pharmaceutical and Biomedical Analysis, 2014

§7.3Related standards

• CEI-MS-03 — Determination of peptide content and its distinction from chromatographic purity
• CEI-MS-04 — Determination of water content in lyophilised peptides by coulometric Karl Fischer titration
• CEI-MS-12 — Residual solvent determination by static headspace gas chromatography

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. 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
2. 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
3. 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
4. European Directorate for the Quality of Medicines & HealthCare. General Monograph 2034 Substances for Pharmaceutical Use. European Pharmacopoeia 2023;11th edition. identifier not held by the Institute
5. D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089

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.