Compilation for open and closed part.
Drug Master File (DMF) is a master document containing complete information on API.
It is a submission to FDA covering factual and complete information on its chemistry, stability, purity, impurity profile, packaging and cGMP status of any API.
We also perform the following studies, in co-operations to DMF preparation :
- Structural Elucidation Studies (Elemental Analysis, IR, Mass, NMR C & H, XRD, DSC),
- Analytical Report (COA)
- Analytical Method Validation
- Process Validation
- Stability data studies
- Determination & Validation of Potential Impurities & Solvent Impurities