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level: Level 2

Questions and Answers List

level questions: Level 2

QuestionAnswer
When do we do photostability testing?1 In phase III of regulatory submission process. 2 The results should be summarized and submitted in an annual report. 3 Starting early in preclinical phase or phase I of clinical trials is highly encouraged
Factors that influence photostability of drug products1 Particle size 2 Drug content 3 Tablet 4 Geometry 5 Preparation method 6 Concentration 7 pH and Ionization
polymorphs in solid dosage form (tablets), surface discoloured to yellow and then orange with results indicating polymorph II to be the least stable.Carbamazepine
photolysis in the presence of visible light at various pH, confirmed that protonated form was more susceptible to photolysis.Cyanocobalamin
forms sulphamoylanthranilic acid after exposure to sunlight.Furosemide