The Analytical Department offers comprehensive services for manufacturers and distributors of medicinal products and cosmetics.
To meet the expectations of our customers we investigate raw materials, intermediate and finished products in the liquid- (suspensions, solutions), semi-solid (ointments, creams, gels) and solid (tablets, capsules) form. Analyses are carried out in accordance with the guidelines of the FP, Ph. Eur., USP, ICH.
The Analytical Department provides quality control services in the field of compliance confirmation of pharmaceutical preparations with the specifications according to SOP and pharmacopoeial guidelines. The research is based on the recommendations of GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice).
The quantitative determination of active pharmaceutical ingredient is routine analysis, but used techniques are different. We have adequate equipment and qualified employees in the field of following techniques: spectrophotometry, head space GC-FID, HPLC with detectors FLD, RID, ECD, UV/VIS-DAD and UHPLC-MS/MS, UHPLC-UV.
European Directives provide to lower and lower limits of impurities in pharmaceuticals. In order to meet the expectations of our customers we continually improve used analytical methodologies, so they have higher selectivity and sensitivity, which entails lower limit of quantification for examined substances.
Identity and physicochemical properties
The preferred technique for qualitative determination of medicinal or auxiliary substances is infrared spectroscopy (IR) and chromatographic methods. The confirmation of the identity using infrared absorption spectroscopy is based on the comparison of the test and standard substance spectrums made under the same conditions. The most commonly used chromatographic techniques are HPLC, TLC and GC. The confirmation of the identity using chromatographic methods is achieved by comparing the retention times or delays coefficients (TLC) of the test and standard substance. In addition, to confirm the qualitative determination can be used physicochemical properties, such as solubility and specific chemical reactions.
We deliver release method development and validation within the GMP certification. Additionally we perform routine release analyses necessary during the quality control production process of final dosage formulations. What’s more we offer the studies to demonstrate the similarity of dissolution profiles for test and reference product in accordance with EMA guideline “Guideline on the Investigation of Bioequivalence”.
We perform ICH stability studies on API and dosage form. Studies are conducted according to the Stability Study Protocols in controlled conditions and fully under GMP conditions.