CEI-MS-19 — references

§7References

§7.1Normative references

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

• General Chapter 2.2.29 Liquid Chromatography — European Pharmacopoeia, 2023
• 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

§7.2Informative references

The following are informative: they support the reasoning of the standard without being conditions of compliance^[4,5].

• HPLC analysis and purification of peptides — Methods in Molecular Biology, 2007
• Related impurities in peptide medicines — Journal of Pharmaceutical and Biomedical Analysis, 2014

§7.3Related standards

• CEI-MS-01 — Determination of chromatographic purity of synthetic peptides by reverse-phase high-performance liquid chromatography
• CEI-MS-08 — Related-substances profiling and the detection of isobaric impurities

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. European Directorate for the Quality of Medicines & HealthCare. General Chapter 2.2.29 Liquid Chromatography. European Pharmacopoeia 2023;11th 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. Mant CT, Chen Y, Yan Z, Popa TV, Kovacs JM, Mills JB, Tripet BP, Hodges RS. HPLC analysis and purification of peptides. Methods in Molecular Biology 2007;386:3–55. doi:10.1007/978-1-59745-430-8_1 · PMID 18604941
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.