Photostability Testing Guidelines of New Drug Substances.

Photostability Testing Guidelines of New Drug Substances

The?ICH Q1B guideline?is the harmonized effort to standardize photostability testing on new pharmaceutical drug substances and drug products.

Photostability Guidelines

Testing is carried out on a single batch of material selected. Whether studies should be repeated depends on the photostability characteristics determined at the time of initial filing and the type of variation and/or change made.

Procedure

The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change.

For confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter.

Samples are exposed side-by-side to ensure the specified light exposure

Samples are exposed?for the appropriate duration of time

Monitoring is completed using calibrated radiometers/lux meters

Dark controls, if specified (wrapped in Alufoil,) placed alongside the authentic sample to evaluate contribution of thermally induced change.

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