Pharmaceutical Analysis LABORATORY
Research Analytical Section
We offer detailed analytical characterisation of chemical and pharmaceutical substances and support for testing various forms of medicines, including tablets, capsules, eye drops, solutions, suspensions, emulsions and ointments. Our services help companies ensure the quality, safety and regulatory compliance of their products.
Based on our research, we prepare documentation that meets the requirements of committees establishing drug quality criteria, including ICH and European and American regulatory authorities. This enables us to help pharmaceutical companies efficiently and safely launch medicinal products on the market, minimising the risk of non-compliance.
Research offer:
EXPERT OPINIONS, STUDIES AND VALIDATIONS OF METHODS IN THE FIELD OF:
- determination of chemical and enantiomeric purity and content of chemical and pharmaceutical substances (HPLC, UHPLC with UV/VIS detection, PDA, Corona CAD, MS)
- determination of chemical and isomeric purity and the content of chemical and pharmaceutical substances (qNMR)
- determining release profiles for active substances in the form (UV-VIS, HPLC, UHPLC with UV/VIS detection, PDA)
- studies on the compatibility of the active substance with excipients at the development stage
- determination of residual solvent content (GC-FID, GC-HS, GC-MS)
- determination of genotoxic impurities, including low molecular weight nitrosamines and nitrosamine drug substance related impurities (NDSRIs) (GC-MS and LC-MS/MS)
- determination of substance content by potentiometric titration
- determination of contaminant content in the form of elements (ICP-MS)
- determination of water content using the volumetric and coulometric Karl Fischer methods,
- determining chemical structure (NMR spectroscopy, FTIR spectroscopy and Raman spectroscopy)
- analysis of phase transitions in solids (X-ray powder diffraction, differential scanning calorimetry, thermogravimetry)
- determination of particle size and shape distribution profiles
- determination of solubility and determination of pKa (UV-Vis)
- stability studies under accelerated and long-term conditions.
CRYSTALLINE FORM RESEARCH FOR ACTIVE SUBSTANCES AND MEDICINAL PRODUCT INGREDIENTS
- X-ray powder diffraction (XRPD)
- differential scanning calorimetry (DSC)
- infrared spectroscopy (FTIR)
- Raman spectroscopy
- thermogravimetry (TGA)
PREFORMULATION RESEARCH
- automated microscopic analysis
- solubility testing of active substances according to Ph. Eur.
ANALYSES IN THE GMP SYSTEM
- X-ray powder diffraction (XRPD)
- gas chromatography with mass spectrometry detection (GC-MS)
- nuclear magnetic resonance (NMR 500 MHz)
- elemental contamination analysis (ICP-MS)
- liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS)
DRUG ANALYSIS
- preformulation testing: solubility testing and release profiles
- physico-chemical tests and pharmaceutical availability tests for different pharmaceutical forms
- analysis of dietary supplements (identity, content, elemental impurities)
- analysis of natural products (identity, content and release) and veterinary products (identity, content, release and chemical purity).
- HPLC and UHPLC liquid chromatographs with UV-Vis, PDA, DAD, CAD detectors (Waters, Shimadzu, Thermo Fisher Scientific)
- QTRAP 4000 tandem mass spectrometer (MDS Sciex/AB Applera Poland (now ABSciex)
- Evolution 220 UV-Vis Spectrophotometer (Thermo Scientific)
- UV-Vis spectrophotometer UV-1800 (Shimadzu)
- Clarus 500 gas chromatograph (PerkinElmer) equipped with Headspace TurboMatrix 40 autosampler (PerkinElmer)
- Gas chromatograph with FID detector, GC-2010 (Shimadzu)
- Gas chromatograph coupled with GC-MS mass spectrometer, QP-2010 Ultra (Shimadzu) equipped with AOC-6000 RTC LIQUID HS autosampler
- Mini Flex 600 powder diffractometer (Rigaku)
- DSC 822e differential scanning calorimeter (Mettler-Toledo)
- Discovery DSC 250 differential scanning calorimeter (TA Instruments)
- TGA/DSC3+ thermogravimetric analyser (Mettler-Toledo)
- Morphology G3S microscopic particle analyser (Malvern)
- LAB40 stereoscopic microscope + MI20 CAMERA (OPTA-TECH)
- Nicolet IS10 FT-IR spectrometer (Thermo Scientific)
- NXR 9650 Raman spectrometer (Thermo Scientific)
- AVANCE III HD 500 MHz NMR spectrometer with probes: BBO (1H, 13C, 2H, 11B, 15N, 19F, 31P) and TCI cryoprobe (Bruker)
- ICP MS 7900 inductively coupled plasma mass spectrometer (Agilent Technologies)
- Microwave mineraliser (Berghof)
- C30 kulometer with Stromboli heater (Mettler-Toledo)
- Tytrator 907 Titrando (Metrohm)
- Apparatus for testing pharmaceutical availability Ph.Eur./USP type 1 and 2 and Enhancer/Immersion Cell 6 independent stations, Symphony 7100 (Distek)
- Semi-automatic apparatus for testing pharmaceutical availability Ph.Eur./USP types 1, 2, 5, 6 and Enhancer/Immersion Cell, 6-station ATS Xtend Offline (Sotax)
- Climate chambers for testing the stability of pharmaceutical products according to ICH Q1A R2, including the CTS C+10/1000 climate chamber with a capacity of 1000 L, Memmert 750 with a capacity of 750 L.
