 |
The Quality Control Department and R&D Analytical Chemistry Department perform analytical studies according to the requirements of such international organizations as ICH and EMA as well
as the Polish Office For Registration of Medicinal Products, Medical Devices and Biocidal Products.
The Department organizes traineeships for the students of pharmaceutical and chemical faculties as well as voluntary training for the post-graduate students. Additional analytical studies are presented on the
LBS - Structural Research Laboratory website.
Polymorphic diagnostic and unique polymorphic studies of pharmaceutical substances:
- Quantitative and qualitative analysis of polymorphic forms using XRPD.
- Determination of the crystal structure of new polymorphic phases using monocrystal X-ray analysis.
- Substance identification in multiphase system - X-ray diffraction data using DHN-PDS,
Poudrixi Fullprof, Shelex 197 and other programs
- Comparative analysis of experimental and literature data using information from the crystallographic data bases (e.g. Cambridge Data Base)
- Determination of the polymorphic form of the pharmaceutical substance contained in a medicinal product.
Our services include:
- Certifying chemical and pharmaceutical substances, excipients and medicinal products.
- Development of analytical methods.
- Chiral compounds analysis using HPLC and CE.
- Structural studies of chemical substances.
- Impurity profile studies.
- Polymorphic diagnostic and unique polymorphic studies of pharmaceutical substances.
- Analytical methods validation according to current ICH requirements.
- Development and validation of analytical methods applied to cleaning processes and technological equipment used in the production of pharmaceutical substances and medicinal products.
- Determination of residual solvents in pharmaceutical substances using classical and Head Space methods.
- Development of analytical methods used in pharmaceutical form studies, including the preparation of a registration dossier.
- Stability tests of pharmaceutical substances and medicinal products stored in validated climatic chambers in the long term 25°C/60% RH, intermediate 30°C/65% RH and accelerated conditions 40°C/75% RH.
- Conducting stress tests and photo stability tests.
- Pharmaceutical availability studies (dissolution tests).
- Contract analyses.
| Quality Control Department |
| |
| Head: |
Hanna Beczkowicz, M.Sc. |
| Phone: |
(+48 22) 456 39 02 |
| Mobile: |
(+48) 601 991 900 |
| Fax: |
(+48 22) 456 38 38 |
| E-mail: |
|
| |
| API Quality Control Laboratory: |
Ewa Chojecka-Koryn, Ph.D. |
| Phone: |
(+48 22) 456 39 01 |
| E-mail: |
|
| |
| Drug Products Quality Control Laboratory: |
Agnieszka Zielinska, M.Sc. |
| Phone: |
(+48 22) 456 39 53 |
| E-mail: |
|
| R&D Analytical Chemistry Department |
| |
| Head: |
Joanna Zagrodzka, Ph.D. |
| Phone: |
(+48 22) 456 39 32 |
| Mobile: |
(+48) 601 333 919 |
| Fax: |
(+48 22) 456 38 38 |
| E-mail: |
|
| |
| API Analytical Laboratory: |
Maria Puchalska, Ph.D. |
| Phone: |
(+48 22) 456 38 99 |
| E-mail: |
|
| |
| Drug Products Analytical Laboratory Laboratory: |
Anna Zielinska, M.Sc. |
| Phone: |
(+48 22) 456 38 14 |
| E-mail: |
|
|
 |
