Analysis and Stability

All laboratory computer systems are validated and meet the requirements of 21 CFR 11. The microbiological and stability testing lab has:

 Glove box with isolators and fume hoods.

 TChromatographic techniques.

 Dissolution baths.

 Spectroscopic techniques.

 Gravimetric thermolysis and differential scanning calorimetry.

 Storage stability chambers.

 FPhysical and wet chemistry methods compatible with USP / EP / JP methods and techniques.