Head of Section
tel. +48 22 37 86 144
The Chemical Analysis Team carries out research in the field of analysis of active substances, medicinal products, excipients, pharmaceutical raw materials in accordance with Ph. Eur., USP, FP in GMP standard.
The scope of activity:
- Development and optimization of analytical methods
- Validation of analytical methods
- Validation of methods for determination of substance residues in the cleaning process of the production line
- Verification of analytical methods
- Transfer of analytical methods
- Certification of the series for compliance with GMP in the field of quality control of medicinal products, active substances, auxiliary substances and raw materials
- Research on pharmaceutical availability for various pharmaceutical forms
- Research on the stability of active substances and medicinal products in qualified climatic chambers under long-term conditions
- Impurity profile analysis – detection, identification and quantification of contaminants in accordance with the requirements of pharmacopoeial monographs (USP, Ph. Eur., FP), recommendations of the International Conference on Harmonization (ICH), requirements of the European Medicines Agency (EMA) ) and the U.S. Medicines and Food Agency (FDA)
- Standardization of the standards of active substances and their impurities.
The research is carried out with the use of high-class apparatus based on a wide spectrum of separation, isolation and identification techniques.
- Liquid chromatography – HPLC (UV / PDA / RI / Fluorescence / Electrochemical) on analytical, preparative and semi-preparative columns, UPLC, SEC, IEC
- Gas chromatography – GC including Head Space with FID detection
- Spectroscopy – IR, NIR, FTIR, UV-VIS
- AAS /AES; Atomic Absorption Spectroscopy/ Atomic Emission Spectroscopy
- Particle size measurements and shape analysis – laser diffraction, microscopic method
- Classical methods: weight and titration analysis
The Chemical Analysis Team has been cooperating with pharmaceutical companies and research institutions in Poland and abroad for many years in the field of quality control of medicinal products and raw materials, development research, expert opinions and consultancy in the drug registration process.