GMP Certified Laboratory

Pharmaceutical Batch release or LOT release Testing
Analytical testing of pharmaceutical products

Main activity of the laboratory:
Physical and chemical testing of starting materials and finished products
Testing stability samples
Analytical method validation
Analytical method transfers
Analytical method development

The analytical testing in the laboratory is made according to the Europian Pharmacopoiea:
Determination of active ingredients
Impurity, decomposition product testing
Identification testing

 HPLCPh.Eur. 2.2.29
 GCPh.Eur. 2.2.28
 Chromatographic separation technicsPh.Eur. 2.2.46
 UV, VIS absorption spectrophotometriaPh.Eur. 2.2.25
 IR absorption spectrophotometriaPh.Eur. 2.2.24
 Thin layer-chromatographyPh.Eur. 2.2.27
 Potenciometric titrationPh.Eur. 2.2.20
 Mass spectrometryPh.Eur. 2.2.43

Classical analytical testing - Physical properties testing

 pH potenciometric determinationPh.Eur. 2.2.3
 Relative densityPh.Eur. 2.2.5
 Melting point determinationPh.Eur. 2.2.14-16
 ViscosityPh.Eur. 2.2.8
 Refractive indexPh.Eur. 2.2.6
 Optical rotationPh.Eur. 2.2.7