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
Our vast experience of over 25 years working with various industries and divers analytical techniques allows our team to quickly develop analytical methods to meet even the most challenging need of our clients. The team at Arbro undertakes the development of analytical methods using HPLC, GC, AAS, HPTLC, ICP-MS, GCMS, LCMSMS, chemical and microbiological and many other techniques. We have a rich library with more than 750 books and access to numerous online journals to keep our team updated with the latest developments enabling us to develop cost-effective, rapid, reproducible and validated methods for even the most challenging applications.
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 Quick Query form on the right with discount code ANADEV in the subject line for special offers and discounts.