The scope of analyses includes:

  • dissolution testing in accordance with methodology provided by customer,
  • development of dissolution test methods with regards to test conditions as well as development and validation of analytical method for assay of API dissolved in medium,
  • statistical evaluation of formulation similarity in terms of pharmaceutical availability determining factor f2; such evaluation might provide information either supporting the argument for waiver of in vivo bioequivalence (BE) or indicating no impact of changes in formulation and/or manufacturing process on product quality
  • development discriminatory dissolution methods for medical products

Dissolution tests, depending on drug dosage form subjected to testing, may be carried out with the following dissolution test apparatus:

  • USP II Apparatus – Paddle
  • USP I Apparatus – Basket
  • USP IV Apparatus – Flow-Through Cell

Tests are carried out in compliance with pharmacopoeial recommendations, relevant EMA and FDA guidances’ recommendations and proper scientific literature data.