Analytical Services

Any pharmaceutical drug product must be tested for its intended use and Critical Quality Attributes. A suitable analytical method is to be developed and validated which plays key role in ensuring drug product quality during development, scaleup and commercialization. In addition to integrated product development, we provide Analytical Services for

Method Development

Optimizing analytical methods to identify or quantify substances, often using techniques like HPLC, GC, and UV-Vis.

Method Verification & Validation

Ensures that an analytical method is suitable, reliable, and reproducible for its intended purpose for regulated markets like the FDA, EMA, and ICH. Compendial methods shall be verified for their suitability to
test the drug product.

Method Transfer

To ensure that the method performs equivalently in the receiving laboratory

Impurity & Degradant Profiling

Any unwanted chemicals that may remain with the active pharmaceutical ingredient (API) during synthesis or API undergoing stress during manufacturing process of drug product & shelf life may lead to degradants.

Batch Analysis and QC Testing

Release Testing of Raw Materials (APIs, & Excipients) & Drug Products.

Stability Studies

To test the product retains its identity, potency, purity, safety,
and efficacy for intended duration at defined storage conditions and establish shelf life.

Instruments

Dissolution apparatus
HPLC with PDA detector
HPLC with UV detector
UV- Visible Spectrophotometer
Stability Chambers
Semi-Micro Balance
Micro Balance
Rheometer
Modular Microscope
Vertical Franz diffusion Cells
Viscometer
Immersion cell

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