Pharmaceutical Analysis LABORATORY
Quality Control Section
We conduct advanced analytical research for the pharmaceutical sector, offering comprehensive services necessary at every stage of the manufacture of medicinal products and active substances.
Our testing provides customers with process assurance, regulatory compliance and end product quality.
We conduct activities in the field of development, validation, transfer and verification of analytical methods, and we confirm the results of our research with Certificates of Analysis. We perform analyses for registration documentation (including IMPD), ageing, stress and stability tests, and standardisation of samples. We operate under a GIF licence for the manufacture of medicinal products, which enables us to provide analytical services to pharmaceutical companies in accordance with applicable quality standards.
Research offer:
QUALITY CONTROL THROUGH A WIDE RANGE OF PHYSICAL AND CHEMICAL TESTS
- raw materials and intermediate products
- active substances
- excipients
- medicinal products, imported medicinal products in various pharmaceutical forms, and investigational medicinal products
- packaging materials
- process control during manufacturing (API/PL/BPL)
- manufacturing conditions, including assessment of the effectiveness of cleaning processes for technological equipment
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS
VERIFICATION AND TRANSFERS OF ANALYTICAL METHODS
- stability testing (long-term, accelerated, intermediate) conducted in qualified climate chambers, in accordance with international ICH guidelines: ‘Stability’ Q1A-Q1F
- ageing studies, both for active substances produced at our Institute and for medicinal products commissioned by contractors
- research work focused on standardising active substance patterns and their impurities
SCOPE OF SERVICES OFFERED
- analysis of chemical substances, active substances, excipients and medicinal products, completed with the issuance of a Certificate of Analysis
- analysis of optically active compounds using HPLC and UPLC.
- development and validation of analytical methods in accordance with current ICH requirements.
- development and validation of analytical methods for cleaning process equipment used in the manufacture of active substances and medicinal products.
- determination of residual solvents in active substances by classical and Head Space methods.
- contaminant profile testing – detection, identification and quantitative determination of contaminants in accordance with the requirements of pharmacopoeial monographs (USP, Ph. Eur., FP), the recommendations of the International Conference on Harmonisation (ICH) and the requirements of the European Medicines Agency (EMA) Harmonizacji (ICH), wymaganiami Europejskiej Agencji ds. Leków (EMA)
- testing the stability of active substances and medicinal products in qualified climate chambers under long-term conditions of 25°C/60% RH and accelerated conditions of 40°C/75% RH, in a refrigerator at 5 +/-3°C or a freezer at -20°C +/- 5°C.
- pharmaceutical availability studies (release profiles) for various pharmaceutical forms.
Our equipment is certified and inspected in accordance with EDQM guidelines, ensuring the highest quality of analysis.
- Shimadzu and Waters HPLC systems (HPLC, UPLC) with UV-VIS, DAD, and refractometric detectors
- GC-2010 gas chromatograph with FID detector (autosampler for liquid samples), Shimadzu
- Gas chromatographs with Head Space attachment, autosampler and FID detector, Clarus 500 – Perkin Elmer, 7890A – Agilent
- IR Spectrum BX spectrometer, Perkin Elmer
- Polarimeter type 341, Perkin Elmer
- UV-VIS Spectrophotometer 2401 PC, Shimadzu
- Titration apparatus: Mettler Toledo –T50, Metrohm – Titrando 907
- Devices for determining water content based on Karl Fischer’s reaction: DL38 Titrator (volumetric detection) and 756 KF Coulometer (coulometric detection)
- MPA 100 Optimelt melting point apparatus, Stanford Research Systems
- DT 700 / 1000 HH pharmaceutical substance release bath, Erweka
- Sulphate incinerator, Milestone
- Analytical scales, Mettler Toledo
- S47 MultiSeven Conductivity Meter, Mettler Toledo (measurements: pH, conductivity, ion concentration)
- KBF 720 and KBF 240 Climate Chambers, Binder
- Highly purified water production system, Barnstead
- Differential Scanning Calorimeter DSC 822, Mettler Toledo
- TGA/SDTA 851 thermogravimetric analyser, Mettler Toledo
- Mini Flex X-ray powder diffractometer, Rikagu
- RL laboratory refractometer, Polish Optical Works
The Quality Control Section conducts tests using the following techniques
- High Performance Liquid Chromatography (HPLC, UPLC)
- gas chromatography (GC-FID, GC-HS)
- thin-layer chromatography (TLC)
- infrared spectroscopy IR
- ultraviolet and visible light spectroscopy (UV-VIS)
- instrumental and classical analysis
