|
Analytical Development ::
Key Role:
To develop analytical methods and techniques to characterize new drug substances and drug products for the physical and chemical properties and to conduct analytical studies in line with worldwide regulatory requirements of the pharmaceutical industry.
Key Capabilities:
- Impurity profiling of NCEs.
- Structural elucidation and characterization.
- Determination of Physico-chemical properties of drug substances such as Solubility, Partition coefficient (LogP), Dissociation constant (pka), Aqueous stability etc.
- Study of polymorphism of drug substances using sophisticated analytical tools such as differential scanning caloriementry, X-ray diffractometry, infrared spectroscopy etc. drug product and drug substance.
- Conducting stability of drug substances and drug product to determine expiry period and appropriate storage conditions.
- Conducting analytical phase during regulatory Toxicology studies, in line with Good Laboratory Practices (GLP).
|
