CMC
ADMET GROUP performs various studies in Chemistry, Manufacturing and Control areas in support of pre-clinical drug development and IND submission.
API Chemical and Safety Specification Design
- Purity and related substances quantitation
- Impurity profiling
- Solvent residues analysis
- Loss on drying
- Karl Fischer
- Microbial tests
- Trace heavy metals
- Long-term condition and acceleration condition stability studies
- Forced degradation study and degradation products analysis
Pre-Formulation, Physicochemical Characterization and Formulation Studies
- Intrinsic aqueous solubility, pH-solubility studies
- Solubility studies in solvents, fixed oils and formulation excipients
- pKa
- Partition coefficient (Log P, n-octanol/water)
- Polymorphism, crystalline / amorphous state (DSC & XRD)
- Crystal habit (optical microscopy, image analysis & SEM)
- Particle size distribution (laser diffraction, sieve analysis)
- Specific surface area (BET method)
- Hygroscopicity
- Bulk & tap density
Clinical Product Chemical and Safety Specification Design
- Purity, related substances and preservative quantitation
- Content and weight uniformity
- Dissolution
- Disintegration
- Hardness
- Organic volatile impurities
- Forced degradation study and degradation products analysis
- Long-term condition and acceleration condition stability studies
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