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Article / Jan 01, 2000

Photostability studies of drug substances and products

  • Fernanda Sequeira
Pharm. Technol. (2000), 24(8), 30, 32, 34-35

The authors studied the photostability characteristics of a drug substance and its formulated product according to the conditions proposed ICH's guideline on photostability. Two photostability apparatuses were designed on the basis of Option 2 recommendations. The results indicate that the conditions provide insufficient details to ensure reproducibility. The current ICH recommendations are subject to different interpretations and therefore need further improvements and better standardization.