CEI-MS-11 — references

§7References

§7.1Normative references

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

• ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products — ICH Harmonised Tripartite Guideline, 1999
• General Chapter ⟨788⟩ Particulate Matter in Injections — 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].

• Protein aggregation — pathways and influencing factors — International Journal of Pharmaceutics, 2010
• 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-07 — Sub-visible particulate matter in reconstituted peptide solutions
• CEI-MS-09 — Assessment of appearance, cake integrity and reconstitution behaviour

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 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
2. United States Pharmacopeial Convention. General Chapter ⟨788⟩ Particulate Matter in Injections. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
3. Wang W, Nema S, Teagarden D. Protein aggregation — pathways and influencing factors. International Journal of Pharmaceutics 2010;390(2):89–99. doi:10.1016/j.ijpharm.2010.02.025 · PMID 20188795
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.