Analytical Method Development
Stability-indicating methods are significant drivers to ensure product quality and ensure faster regulatory approval. Our method development strategy involves the use of proper scientific approaches and scientific literature reviews which lead to the appropriate selection of analytical techniques for the targeted product.
MALPL team is capable of developing analytical methods using QbD approach for various Drug Substances and Drug Products.
Our team is masters in Method Development of the following:
- Assay & Dissolution by HPLC (stability indicating), UV & by GC.
- Residual solvents by GC/GCHS,
- Enantiomeric purity by HPLC,
- Related substances by HPLC,
We support, our customers by developing appropriate analytical methods with ‘First Time Right’ concept, without compromising on quality and completing projects within agreed timelines.
