CEI-MS-20 — 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. Expose samples to not less than 1.2 million lux hours of visible light and 200 watt hours per square metre of near-ultraviolet energy.
2. Run a dark control wrapped in aluminium foil alongside, to separate thermal from photolytic degradation.
3. Expose in both the container in which the compound is supplied and in a transparent container, to determine the protection the supplied container affords.
4. Analyse by a stability-indicating method validated for photolytic degradants under CEI-MS-13.
5. Where tryptophan is present, acquire full diode-array spectra and record absorbance at 320 nm as an indicator of N-formylkynurenine formation.
6. Report degradation in each container type, the dark-control result, and the illumination actually delivered as measured rather than as nominal.

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.