Method Development Method Validation Method Transfer Stability Studies and Evaluation Structure Elucidation and Evaluation

Fundamental criteria for the approval and acceptance of any drug product, stability investigations of pharmaceutical formulations are vital for assessing their efficacy and safety over the whole shelf life. Pharmaffiliates caters its clients with

  • R&D preliminary studies
  • Quality control stability studies and release testing
  • Comparator studies
  • Photostability studies

Stability tests at Pharmaffiliates are run according to ICH Q1A–Q1F standards. Applied on a broad spectrum of APIs and pharmaceutical items throughout stability testing, our Analytical Research Department creates strong stability-indicating techniques.

To guarantee data integrity and regulatory alignment, all run under standard operating procedures and totally compliant with 21 CFR Part 11, we use fully qualified stability equipment including walk-in chambers, stability ovens, and sophisticated analytical tools.

Large Molecules
CPHI INDIA- 28, 30 November