- Bioequivalence in vitro according to ICH guidelines ,
- Partition coefficient – Flask Shake Method,
- Stability under Xenon light, %RH and Temperature,
- Solubility and comparative dissolution studies,
- Development of HPLC and Particle Size Distribution (PSD) methods,
- Development and study of metastable zone of the crystallization process.
Finally, PolyCrystalLine is GLP certified and this month has required the GMP certification for qualitative/quantitative XRD analyses.
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