CEI-MS-06 — references

§7References

§7.1Normative references

The following are normative for this standard: compliance with the standard requires compliance with them^[1,2,3,4,5].

• General Chapter ⟨71⟩ Sterility Tests — United States Pharmacopeia — National Formulary (USP–NF), 2024
• General Chapter ⟨85⟩ Bacterial Endotoxins Test — United States Pharmacopeia — National Formulary (USP–NF), 2024
• General Chapter ⟨795⟩ and ⟨797⟩ Pharmaceutical Compounding — Nonsterile and Sterile Preparations — United States Pharmacopeia — National Formulary (USP–NF), 2023
• ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories — ISO/IEC Standard, 2017
• WHO Expert Committee on Specifications for Pharmaceutical Preparations — Fifty-seventh report — WHO Technical Report Series, 2023

§7.2Informative references

This standard cites no informative reference.

§7.3Related standards

• CEI-MS-05 — Bacterial endotoxin determination in peptide preparations intended for parenteral use

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 ⟨71⟩ Sterility Tests. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
2. United States Pharmacopeial Convention. General Chapter ⟨85⟩ Bacterial Endotoxins Test. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
3. United States Pharmacopeial Convention. General Chapter ⟨795⟩ and ⟨797⟩ Pharmaceutical Compounding — Nonsterile and Sterile Preparations. United States Pharmacopeia — National Formulary (USP–NF) 2023;USP 2023 Issue 2. identifier not held by the Institute
4. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
5. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations — Fifty-seventh report. WHO Technical Report Series 2023;No. 1044. identifier not held by the Institute

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.