CEI-MS-13 — references

§7References

§7.1Normative references

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

• ICH Q2(R2) Validation of Analytical Procedures — ICH Harmonised Guideline, 2023
• ICH Q1A(R2) Stability Testing of New Drug Substances and Products — ICH Harmonised Tripartite Guideline, 2003
• 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^[4,5].

• Related impurities in peptide medicines — Journal of Pharmaceutical and Biomedical Analysis, 2014
• Stability of protein pharmaceuticals: an update — Pharmaceutical Research, 2010

§7.3Related standards

No other standard in this category has been published.

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. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q1A(R2) Stability Testing of New Drug Substances and Products. ICH Harmonised Tripartite Guideline 2003;Step 4 version. identifier not held by the Institute
3. 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
4. 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
5. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256

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.