CEI-MS-21 — system suitability and acceptance criteria

§5System suitability and acceptance criteria

§5.1System suitability

Table 1. System suitability criteria. A determination is reportable only where every criterion is met at the time of analysis.

§5.2Acceptance criteria

• An in-use period is supportable only where every monitored attribute remains within its acceptance criterion throughout the claimed period and the method is stability-indicating.
• Purity data alone do not support an in-use claim for any compound in a class prone to aggregation.
• In the absence of such data the Institute publishes no in-use claim, and records that the manufacturer of one approved lyophilised peptide claims only three hours after reconstitution — a figure arrived at with full stability data.

§5.3Limitations

References cited on this page

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 Q1A(R2) Stability Testing of New Drug Substances and Products. ICH Harmonised Tripartite Guideline 2003;Step 4 version. identifier not held by the Institute

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