Any pharmaceutical drug product being developed has to be tested for its intended use and Critical Quality Attributes.
A suitable analytical method is to be developed and validated which plays the key role in the manufacture and supply of a quality drug product.
We provide analytical support for Method Development and Validation in accordance with ICH and Pharmacopeia standards.
State of the art laboratory with latest equipments like UPLC, Malvern 3001, ICPMS etc.,
Method Development & Validation
- API and and Drug Product.
- Stability indicating methods
- Validation of analytical methods,
- Impurity Profiling, Isolation and characterization.
- Extractable and leachable.
- Raw materials : API & Excipients
- Finished product: Complete analysis and Multi media dissolution profiling
- Drug product stability testing (as per ICH guidance)
- Extractables and leachables
- Elemental analysis
- Microbial testing