| Document title |
Contents |
| Comparison report on both APIs |
Synthetic route (starting material, impurities profile, residual solvents), Physical properties (particle size, bulk density, polymorphism, solubility), Specifications, Analytical procedures and Method validation |
| DP development |
Comparison report for API physicochemical properties, DP impurity profile, Updated components and composition statement, analytical method validation reports. Risk assessments and QbD elements reconfirmation. |
| New manufacturing batches with proposed API |
Intended master batch records for the largest intended commercial batch size (US), Executed batch manufacturing record (for USFDA), Batch analysis CoA, in-vitro dissolution results, in-vitro dissolution comparison report with old API mfg. batches, 6months accelerated and long term stability data and stability commitment for long term/intermediate conditions. |
| CTD sections |
DS CMC part: Module-2 QOS and Module-3 DS part |
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