level: Level 2
Questions and Answers List
level questions: Level 2
| Question | Answer |
|---|---|
| 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 products | 1 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 |