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Analytical method development & validation

Analytical Method Development & Validation Expertise
Custom ICH-Compliant Methods for Pharma Product Lifecycle

Overview Service

Capzer Pharmaceuticals specializes in analytical method development and validation for drug substances, products, and impurities, supporting all phases from R&D to commercial release. Our FDA-registered, cGMP-compliant lab follows USP, EP, JP, ICH Q2(R1), and FDA guidelines to create robust, stability-indicating methods.​​

Our Approach

Senior scientists develop methods using HPLC-UV/PDA/MS-MS, UPLC, GC-MS, ICP-MS, dissolution baths, and FTIR, including forced degradation studies for specificity. We draft custom protocols, perform full validation (accuracy, precision, linearity, LOD/LOQ, robustness), and provide comprehensive reports ready for ANDA/NDA submissions.

Key Capabilities

  • Stability-indicating assays, impurity profiling, and enantiomer separation.
  • Method transfer, verification, and revalidation for post-approval changes.
  • Support for complex generics, nitrosamines, and elemental impurities.​

Benefits for Partners

Partners gain accelerated development timelines, regulatory confidence, and cost savings through our integrated GMP facility. This ensures seamless scale-up for U.S. generics like Empagliflozin and supports long-term quality control in chronic disease markets.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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