Stability assessment of drug products and drug substances are mandated by regulatory agencies across the globe. All our studies follow ICH guidelines and are performed in an auditable lab with proper documentation. CFR 21 compliant Chambers are used for storage of stability samples.

Stability Study lab in R&D carries out a number of analytical tests which includes:

1. RP-HPLC
2. SE-HPLC
3. Ion-Exchange Chromatography (IEC)
4. Peptide Mapping
5. SDS polyacrylamide gel electrophoresis (reducing and non-reducing)
6. Iso-electric Focusing (IEF)
7. Measurement of protein concentration (UV absorbance, Bradford etc.)
8. Immuno-Blotting

These methods are routinely performed at various time points under conditions of different temperature and humidity (Real time, Accelerated and Stress studies). Samples are given to QC dept. for Bioburden, Sterility and Bacterial Endotoxin Tests.

If required, these studies can be performed in QC department under cGMP conditions.

In addition to the routine analysis, various exploratory studies are also conducted including Shear Stress, Accidental Freezing, Photo-stability studies and Container closure comparability studies. We also use High-end Microcal Differential Scanning Calorimeter (DSC), for studying the thermal stability of various formulations under the effect of various excipients and additives. Product related impurities, if generated, during the course of study are properly identified and characterized to a great extent.