CEI-MS-08 — references

§7References

§7.1Normative references

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

• ICH Q2(R2) Validation of Analytical Procedures — ICH Harmonised Guideline, 2023
• General Chapter ⟨1225⟩ Validation of Compendial Procedures — United States Pharmacopeia — National Formulary (USP–NF), 2024

§7.2Informative references

The following are informative: they support the reasoning of the standard without being conditions of compliance^[3,4,5].

• Related impurities in peptide medicines — Journal of Pharmaceutical and Biomedical Analysis, 2014
• HPLC analysis and purification of peptides — Methods in Molecular Biology, 2007
• LC–MS bioanalysis of intact proteins and peptides — Biomedical Chromatography, 2020

§7.3Related standards

• CEI-MS-01 — Determination of chromatographic purity of synthetic peptides by reverse-phase high-performance liquid chromatography
• CEI-MS-19 — Purity determination for peptides not retained by conventional reverse-phase 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. 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
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. 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
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. Kang L, Weng N, Jian W. LC–MS bioanalysis of intact proteins and peptides. Biomedical Chromatography 2020;34(1):e4633. doi:10.1002/bmc.4633 · PMID 31215680

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.