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Dissolution testing for pharmaceuticals products (tablet & capsules)

Dissolution Testing for Tablets & Capsules
USP Apparatus I/II Profiles for ANDA & Release Testing​​

Overview Service

Capzer Pharmaceuticals conducts cGMP-compliant dissolution testing for immediate/extended-release tablets and capsules per USP <711>, supporting product development, stability, and commercial release. Our FDA-registered lab ensures bioequivalence demonstration for generics across chronic therapies.​​

Our Approach

Using validated USP Apparatus 1 (basket) and 2 (paddle) with dissolution baths, we test under specified media (pH 1.2-6.8, surfactants), speeds (50-100 rpm), and temperatures (37°C). Samples undergo HPLC/UPLC analysis for % dissolved vs. time, with f2 similarity calculations and full IVIVC profiling.​​

Key Capabilities

  • IR/ER formulations, discriminatory method development, and media optimization.
  • Dose dumping studies, apparatus suitability, and sink condition verification.
  • Multi-stage testing for complex generics like Bupropion XL.

Benefits for Partners

Partners accelerate ANDA approvals with reliable, regulatory-ready dissolution data from our integrated 20,000 sq. ft. facility. This supports scale-up from pilot (10k units) to commercial batches (5M+) while ensuring consistent drug release performance.

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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