Analytical procedure and Development

Analytical Procedure and Development

The new development of methods for the analyses of new active product ingredients of the drug products, fixed-dose combinations, and inactive substances is an ongoing requirement for all pharmaceutical product manufacturers. It is most required to support new product development and daily quality control, for regulatory submissions, stability studies, cleaning validation studies, and analysis of related substances and impurities.

IIRT specializes in the development of methods for –

Single drugs and fixed-dose combinations Assay.

Methods of Stability indicating assay.

Method of Impurity Profiling.

Validation studies of Single and multidrug methods for cleaning

Methods of Dissolution (in vitro in vivo correlation) for immediate release and sustained release products with IVIVC

Organic volatile impurities and residual solvents Methods.

Heavy metals and metal catalysts such as Lead, Palladium, Rhodium, and Zirconium using AAS and ICP-MS for limit tests.

Analytical methods for critical excipients like preservatives and stabilizers

Methods for multivitamin formulations

IIRT has vast experience with various industries and diverse analytical techniques and developed analytical methods to meet even the most challenging need of our clients. The team of IIRT undertaking the development of analytical methods using HPLC, GC, AAS, HPTLC, ICP-MS, GCMS, LCMSMS, chemical and microbiological, and other techniques.

Methods developed by IIRT are fully validated as per the current requirements laid down in the ICH guidelines.

Over the years we have developed and validated hundreds of analytical methods.

Please contact us with your requirements at info@toxicityindia.org; iirtdelhi@gmail.com, visit: www.toxicityindia.org

Send Enquiry