Our experienced analysts develop robust analytical methods using techniques such as HPLC, GC, UV, and FTIR, followed by method validation as per ICH Q2 (R1) guidelines.

• Assay & RS Method Development

• Dissolution Media Optimization

• Analytical Method Transfer (AMT) & Verification (AMV)

• Short-run, rugged methods for production use

We conduct forced degradation and stress testing to determine the stability-indicating nature of drug substances and products.

• Identification of degradation pathways

• Stability-indicating method development

• Impurity and degradant profiling using hyphenated techniques

We offer long-term and accelerated stability testing as per ICH Q1 guidelines, supporting shelf life estimation and regulatory submissions.

• Real-time and accelerated conditions

• Photostability Testing

• Zone I–IV coverage

• Container-closure compatibility studies

Detection, quantification, and validation of impurities including:

• Nitrosamines & Genotoxic Impurities (by LC-MS/MS)

• Residual Solvents (Class 1, 2, 3) by GC-HS

• Validation and technology transfer of impurity methods

We analyze fine particle size and distribution in APIs, injectables, and excipients using laser diffraction techniques.

• Mean Volume, Surface Area & Mass

• Graphical and tabular reporting

• Compliant with pharma and allied industry standards