Pharmaceutical Dosage Form Analysis Department



Pharmaceutical Dosage Form Analysis Department carries out analytical studies on different pharmaceutical dosage forms (tablets, capsules, solutions, eye drops in the form of solutionsand suspensions, emulsionsand ointments). As a result of the conducted research analytical documentation is prepared that meets the requirements of the ICH as well as of European and American registration authorities. Our research results are regularly published and presented at scientific conferences.
Our primary activities include development of analytical methods for the determination of assay, chemical and enantiomeric purity, full impurity profiles andAPI dissolution profilesinpharmaceutical dosage forms. We also conduct API and excipients compatibility studies at the development stage and stability studies inaccelerated, medium and longterm conditions.

Detailed data on the range of the services offeredcan be found in our Offer.

Pharmaceutical Dosage Form Analysis Departmentuses the following analytical techniques:

  • High-performance liquid chromatography(HPLC) in isocratic and gradient modesusing PDA and UV detectors and ultra performance liquid chromatography (UPLC))
  • Thin-layer chromatography(TLC)
  • UV spectrometry
  • Equipment allowing to study API release from solid and semi-solid pharmaceutical dosage forms

Personnel:

  • 8 employees with higher education degrees
Head:Edyta Pesta, M.Sc.
Land line:(+48 22) 456 38 94
Mobile:(+48) 605 571 760
E-mail:e.pesta@ifarm.eu