Analytical Development
Development of analytical methods for new active pharmaceutical ingredients, drug products, fixed dose combinations and excipients is an ongoing requirement for all pharmaceutical companies. It is required to support new product development and routine quality control, for regulatory submissions, stability studies, cleaning validation studies, analysis of related substances and impurities.
We specialize in the development of methods for –
- Assay of single drugs and fixed dose combinations
- Stability indicating assay methods
- Impurity profiling methods
- Single and multidrug methods for cleaning validation studies
- Dissolution methods for immediate release and sustained release products with IVIVC (in vitro in vivo correlation)
- Methods for organic volatile impurities and residual solvents
- Limit tests for heavy metals and metal catalysts such as Lead, Palladium, Rhodium, Zirconium using AAS and ICP-MS
- Analytical methods for critical excipients like preservatives and stabilizers
- Methods for multivitamin formulations
- Methods for particle size analysis using Malvern Mastersizer 3000 – laser diffraction particle size analyzer
All methods developed by our lab are fully validated as per the current
requirements laid down in the ICH guidelines Q2(R1).
Over the years we have developed and validated hundreds of analytical methods.
Some of the methods developed independently by our team have been published in
reputed journals and presented at conference, a list of some of the publications
can be seen on Our publications page.
We are confident that if you have an analytical problem we will have a solution
for it!
Contact us today with your requirements using the Query form on the right.