CEI-MS-21 — procedure

§4Procedure

The procedure below is written in the second person, which is the only place in the Institute's document set where that register is used. A procedure is an instruction and is written as one.

1. Reconstitute to the concentration and in the diluent actually used in practice, not to a convenient analytical concentration.
2. Sample at time zero for purity, aggregate content, pH and appearance.
3. Hold at the claimed storage condition and sample at intervals covering at least the claimed period and one interval beyond it.
4. For a freeze–thaw claim, subject aliquots to the number of cycles to be claimed plus one, with a defined freezing and thawing rate, and sample after each cycle.
5. Determine purity, aggregate content, pH, appearance and content at each timepoint.
6. Where a preservative is present, determine preservative content, since a bacteriostatic agent that has degraded no longer protects a multi-dose preparation.
7. Report each attribute against time, and state the claim the data support rather than the claim that was hoped for.

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

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.