DEPARTMENT OF PHARMACEUTICAL CHEMISTRY (CF)

Personnel and structure:

Head of the Department: Zbigniew E. Fijałek, Professor

Secretary: Marzena ¦miech
tel.: +48 022 841 21 21 ext. 244;
+48 022 851 52 45 ext. 244;
fax: +48 022 331 15 63
E-mail:  sekretariatcf

Electrochemical Methods Lab
Agata Błażewicz, Ph.D.
Małgorzata Warowna-Grze¶kiewicz, Ph.D.
Karolina Stypułkowska, M.Sc.
Piotr Baran, M.Sc.

Atomic Spectrometry Lab  
Monika Kiljan, M.Sc.
Krystyna Mętrak, M.Sc.
Krystyna Glige

Pharmaceutical Analysis Lab
Katarzyna Sarna, Ph.D.
Piotr Suchocki, Ph.D.
Jadwiga Metlerska, M.Sc.
Teresa Garbowska, M.Sc.
Mariola Bobek
Magdalena Jesiotr
Edyta Jaczewska
Sylwia Przygodzka
Bożena Bogdaniuk

Activities:

Quality control of medicinal products and raw materials:

Control activity covers tests concerning medicinal products acting on cardiovascular system (organic nitrates), general and local anesthetics, contrast and diagnostic preparations used in roentgenology and magnetic resonance, analgesics and anti-inflammatory preparations, products neutralizing acids in the stomach, diet supplementary products (micro and macro elements), sulphonamids, cytostatics (with built-in Platinum).

Control activity includes raw materials and medicinal products undergoing the registration procedures as well as those already present on  Polish pharmaceutical market. Evaluation of analytical dossier of the products which are actually during the registration process is also performed in the department.
Variety of methods are used in control and research activity:
Instrumental - atomic absorption spectrometry (AAS), inductively coupled plasma mass spectrometry (ICP MS), HPLC with UV, polarimetric, fluoroscentic, amperometric detection.
Electrochemical - voltammetry, polarymetry, potentiometry
As the only Lab in Poland our department carries out tests of different therapeutic products by investigation of the electrochemical processes with the usage of electrochemical quartz crystal microbalance (EQCM).
In 1999, the department was equipped as the first lab in Poland, with the mass spectrometer with inductively coupled plasma ICP-MS and carries out determinations of selected elements on the trace level (ppb and ppt)  by spectroscopic and electrochemical methods.
All methods are used in control activity as well as in the research.

Quality Assurance

  • Implementation of the quality system according to PN-EN ISO/IEC 17025: 2001.
  • Elaboration of the documents of quality system
  • Participation in the PTS (Proficiency Testing Studies) organized by EDQM (European Directorate for Quality of Medicines) in collaboration with European Pharmacopoeia Commission.
  • Elaboration, under the instructions of EDQM, of the procedure of cadmium determination in raw material (Lini semen), providing the base for the inter-laboratory testing within the OMCL-network.

Educational activity

  • Lectures and trainings covering:
    - quality assurance in quality control of medicinal products,
    - electrochemical and spectroscopic methods used in pharmaceutical analysis.
  • Summer school for students from:
    Medical University of Warsaw,
    Warsaw University,
    Warsaw Agricultural University.
  • Management over the M.Sc. diploma works.

Reasearch:

  • Using of electrochemical methods in quality testing of raw materials and medicinal products, elaboration or adaptation of methods alternative to pharmacopoeial methods.
  • Application of spectroscopic methods in medicinal products and raw materials quality testing; elaboration or adaptation of methods alternative to pharmacopoeial methods.
  • Testing of metal speciation in raw materials and medicinal products.
  • Determination of selected trace elements in multi-components medicinal products and organic matrixes.

Research projects:

  • Electrochemical and spectroscopic testing of isocyanians and their complexes with Zinc.
  • Testing of Selolol cytotoxicty against multi-resistant cells.

Cooperation

  • EDQM  (proficiency testing),
  • Polish Pharmacopoeia (the head of the departament acts as well as the head of Physico-chemical
  • Methods Sub-commission, one scientist from the department is the Sub-commission member)
    Forschungszentrum Julich (Germany) - determination of elements in complex matrixes - herbal drugs and multivitamins and multielements preparations.
  • Universities:
    - Medical University of Warsaw (summer trainings, diploma works),
    - University of Science and Technology (electrochemical tests)

Services

  • Quality and quantity testing of raw materials, active substances, medicinal products and medical devices with the regard to their compliance with current pharmcopoeial monographs and specifications of the manufacturers.
  • Determination of macro and microelements in raw materials and natural medicinal products.
  • Determination of heavy metal content in raw materials and herbal medicinal products.
  • Training covering electrochemical and spectroscopic methods.
  • Elaboration of Standard Operation Procedures and validation of analytical methods.

Equipment

  • HPLC system with UV, spectrofluorometric, polarimetric, amperometric detection,
  • Spectroscopic equipment: polarimeter, refractometer, spectrophotometer UV/VIS, AAS, ICP-MS,
  • Dissolution testing sets with UV, HPLC, EC detection,
  • Electrochemical sets for potentiometeric titration, polarographic, voltammetric (electrodes:Hg,Au,Ag,Pt, glassy carbon) conductometric tests.
  • Sets for water determination by K.Fischer method,
  • Electrochemical quartz crystal microbalance,
  •  Microwave mineralization sets.

Main publications since 2000

  • E. Wyszecka-Kaszuba, M. Warowna-Grze¶kiewicz, Z. Fijałek
    Determination of 4-aminophenol impurities in selected
    pharmaceutical preparations by HPLC method with amperometric
    detection.
    Acta Polon. Pharm. 58, 325-329 (2001).
  • A. Łozak, K. Sołtyk, P. Ostapczuk, Z. Fijałek
    Determination of selected trace elements in herbs and their
    infusions.
    Sci. Total Environ. 289, 35-40 (2002).
  • E. Baczyński, A. Piwońska, Z. Fijałek
    Determination of 2,6-dimethylaniline and o-toluidine impurities in
    preparations for local anesthesia by the HPLC method with
    amperometric detection.
    Acta Polon. Pharm. 59, 333-339 (2002).
  • Z. Fijałek, K. Sołtyk, A. Łozak, A. Kominek, P. Ostapczuk
    Determination of some micro- and macroelements in preparations
    made from peppermint and nettle leaves.
    Die Pharmazie 58, 480-482 (2003).
  • K. Sołtyk, A. Łozak, P. Ostapczuk, Z. Fijałek
    Determination of chromium and selected elements in multimineral
    and multivitamin preparations and in pharmaceutical raw materials.
    J. Pharm. Biomed. Analysis 32, 425-432 (2003).
  • Z. Fijałek, K. Sarna, T. Kasprzycka-Guttman
    Voltammetric and electrochemical quartz crystal microbalance
    studies of sulforaphane and its Zn (II) complexes.
    J. Pharm. Biomed. Analysis 32, 967-974 (2003).
  • E. Wyszecka-Kaszuba, M. Warowna-Grze¶kiewicz, Z. Fijałek
    Determination of 4-aminophenol impurities in multicomponent
    analgesic preparations by HPLC with amperometric detection.
    J. Pharm. Biomed. Analysis 32, 1081-1086 (2003).                      
  • A. Łozak, K. Sołtyk, P. Ostapczuk, Z. Fijałek
    Determination of chromium, selenium and molybdenum in a therapeutic diet.
    Die Pharmazie 59, 824-827 (2004).
  • Z. Fijałek, E. Baczyński, A. Piwońska, M. Warowna-Grze¶kiewicz  
    Determination of local anaesthetics and their impurities in pharmaceutical preparations using HPLC method with amperometric detection.
    J. Pharm. Biomed. Analysis 37, 913-918 (2005).
  • P. Kowalczyk, A. Łozak, Z. Fijałek
    Selenium determination in multicomponent pharmaceuticalpreparations.
    Chem. Anal. 50, 437-447 (2005).