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ANALYTICAL R&D

Analytical Research & Development plays a critical role throughout the pharmaceutical product lifecycle from API and excipient evaluation through formulation development, stability assessment, technology transfer, regulatory submission and commercial product support.

Our Analytical R&D function is focused on developing scientifically sound, accurate, precise, robust and stability-indicating analytical methods appropriate for their intended purpose.

Key Analytical R&D Capabilities

Our analytical development activities include:

      1. Analytical method development and optimization
      2. Analytical method validation and verification
      3. Stability-indicating method development
      4. Dissolution method development and comparative dissolution profiling
      5. Cleaning method development and validation support
      6. Method transfer to Quality Control laboratories
      7. Stability study testing and trend evaluation

Analytical Instrumentation 

Our R&D laboratory is equipped with multiple HPLC systems with PDA detectors, gas chromatography, UV-visible spectrophotometers, automated dissolution testers, and stability chambers designed to support global stability requirements.