Pharmaceutical Analysis LABORATORY
Chemical Analysis Section
We conduct comprehensive research
– active substances
– medicinal products,
– auxiliary substances
– pharmaceutical raw materials
in accordance with the requirements of the Ph. Eur., USP, FP pharmacopoeias in the GMP standard.
For years, we have been supporting pharmaceutical companies and research centres in Poland and worldwide, offering:
- quality control of medicinal products and raw materials,
- research and development supporting innovation,
- expert opinions and consulting in the drug registration process.
We specialise in developing dedicated analytical methods, precisely tailored to the characteristics of pharmaceutical products, ensuring compliance with regulations and safety standards.
Our experience is confirmed by GMP and ISO 9001 certificates, as well as audits conducted by clients and the Main Pharmaceutical Inspectorate.
OFFER:
- batch certification and testing in quality control of medicinal products, active substances, starting materials and packaging materials, excipients and raw materials
- development, optimisation, verification and validation of analytical methods
- transfer of analytical methods
ANALYTICAL TECHNIQUES:
- liquid chromatography – HPLC (UV/PDA/RI), UPLC, SEC, IEC,
- gas chromatography – GC, including Head Space – with FID detection
- thin-layer chromatography (TLC)
- IR, UV/Vis spectrophotometry,
- atomic absorption spectrometry (AAS) with flame atomisation (FAAS) and graphite furnace atomisation (GFAAS), and atomic emission spectrometry (AES).
- potentiometry
- classical methods: gravimetric analysis, titrimetric analysis
RESEARCH POTENTIAL:
- determination of the content and identity of chemical and pharmaceutical substances
- contamination profile testing (including determination of degradation products and other contaminants; solvent residues, enantiomeric purity)
- research on pharmaceutical availability for various pharmaceutical forms
- active substance release testing
- testing the stability of active substances and medicinal products in qualified climate chambers under short- and long-term conditions
- water content labelling
- designation of mass loss after drying
- determination of trace metal content
- determination of particle size and shape distribution profiles
- osmolarity measurement
- colour determination
- testing the solubility of active substances according to Ph. Eu.
- half-life
- verification and validation of process equipment cleaning (using swabs or rinses)
- Cobas e411 analyser
- Apparatus for testing tablet disintegration time
- Tablet hardness tester
- Apparatus for coulometric determination of water content using the KF method
- Apparatus for volumetric determination of water content using the KF method
- Titration apparatus
- Apparatus for determining the melting point
- Apparatus for releasing active substance from tablets
- Mastersizer 2000 particle size analyser
- Liquid chromatographs with detectors: PDA, RI, UV-Vis
- Ion chromatograph with conductometric detector
- Gas chromatographs with Head Space attachment and FID detector
- Climate chambers
- Photostability climate chamber
- Cone-plate viscometer
- NIKON microscope
- Osmometer
- Pressure osmometer
- Stoves
- pH meter
- Polarimeter
- IR spectrometer
- UV-VIS spectrophotometer
- FAAS spectrometer
- GFAAS spectrometer
- FT-IR spectrometer
- Titrators
- Analytical scales
