CEI-MS-04 — 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 ⟨921⟩ Water Determination — United States Pharmacopeia — National Formulary (USP–NF), 2024
• ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products — ICH Harmonised Tripartite Guideline, 1999
• ICH Q1A(R2) Stability Testing of New Drug Substances and Products — ICH Harmonised Tripartite Guideline, 2003

§7.2Informative references

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

• Stability of protein pharmaceuticals: an update — Pharmaceutical Research, 2010
• Rational design of stable lyophilized protein formulations: some practical advice — Pharmaceutical Research, 1997

§7.3Related standards

• CEI-MS-03 — Determination of peptide content and its distinction from chromatographic purity
• CEI-MS-10 — Identification and quantification of counter-ions in synthetic peptide salts
• 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 ⟨921⟩ Water Determination. 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 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
3. 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
4. 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
5. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharmaceutical Research 1997;14(8):969–975. doi:10.1023/a:1012180707283 · PMID 9279875

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.