Exeltis offers a full array of analytical services thanks to its world-class cGMP facilities and instrumentation, technical know-how and experienced scientists. Equipped with sophisticated apparatus like UV spectrophotometer, GC, HPLC, FTIR and auto-titrator, the objective of the ARnD team is to develop robust analytical methods for every formulation developed by the FRnD team. Each analytical method developed in-house is validated before commercialisation to ensure that product quality is always maintained at a consistent level. Moreover, a number of industry best practices are adopted in ARnD for documentation to enable effective technology transfer of products and to deliver uncompromised high-quality formulations. And last but not least, the walk-in stability chambers in ARnD provide periodical (both real-time and accelerated) stability studies as per ICH guidelines.

Method development and validation

• Qualified team to develop analytical methods that support formulation studies right from raw materials to finished dosage forms
• Stereo chemical impurity studies and degradation studies as per global requirements and benchmarks
• Established procedure for validation of analytical house methods from start to finish

Stability

• Stability chambers equipped to run 24/7 without interruptions; designed for real and accelerated time stability studies as per ICH guidelines
• 3 stability chambers (8000 litres each) for simultaneous monitoring of multiple samples
• Dedicated team to carry out periodical stability studies of product under development