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Standards category

Microbiological quality

2 standards in the microbiological quality category.

All categories Chromatographic purity (3)Identity (1)Content (4)Physical quality (3)Microbiological quality (2)Method validation (1)Stability (2)Documentation (2)

Standards

2 documents

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

CEI-MS-05Microbiological qualityversion 1.18 procedural steps

Applies to any peptide preparation that will be reconstituted and administered parenterally, including all material supplied for research use that is presented in a vial with a rubber closure. The Institute records that this determination…

10 May 2026
CEI-MS-06 — Sterility testing of peptide preparations presented in sealed vials

CEI-MS-06Microbiological qualityversion 1.07 procedural steps

Applies to lyophilised or solution presentations intended for parenteral administration. The Institute records that no supplier in its assessment set reports a sterility determination for research-supply material.

22 Oct 2023

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