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Analytical method development and validation

Reliable and reproducible analytical methods are indispensable for the evaluation of both the pharmaceutical development processes and the product, and for the proving of compliance with the efficiency, purity, and stability specifications. The task of the laboratory employees is the development, testing, and validation of analytical methods related to the new products. Analytical development works closely together with the technology development from the initial state of the finished product development (preformulation). It may occur – like in the case of new pharmacopoeia releases – that the introduced analytical methods also need modification and revalidation.

  • Method development, validation, and routine testing
  • Quantity, effect, and composition identity definition
  • Analysis and comparison of contaminants, decomposition products, additives, impurity profiles deriving from production processes
  • Stability analyses and their evaluation
  • Release of registry batches (stability programme)