Analyses for pharmaceuticals industry

Medicines and medicinal products are among those that are subject to the strictest monitoring regarding safety.

The official certification authority for the Czech Republic is the State Institute for Drug Control (SIDC); without the relevant certificate from this authority, the possibilities of carrying out analyses and services in the pharmacy field, in general, are minimal.

LABTECH laboratory holds the Certificate of GMP compliance from SIDC for the quality control of production operations and the quality control of imported medicinal products for human use through the implementation of chemical and physical methods. (link or click – Certificates)

Especially for the field of pharmacy, our experts are ready to develop new original measurement and testing methods and carry out their full validation.

Who are our clients?

• Pharmaceutical companies - manufacturers
• Suppliers of raw materials for pharmaceutical companies
• Importers of medicinal products
• Manufacturers of medical devices and cosmetic products

What do we offer?

• Selective determination of metals according to ICH Guideline Q3D in drugs, medicinal substances and excipients (auxiliary substances) and in raw materials or intermediate products in the GMP and non-GMP regimes
• Validation of the above determinations
• Development of measurement and testing methods, their complete validation (residual volatile solvents of ICH Guideline Q3C, anions by ion chromatography and others)

Due to new instrumentation:

• LC/MS/MS - liquid chromatograph with tandem mass spectrometer (with triple quadrupole)
• GC/MS/MS gas chromatograph with tandem mass spectrometer (with triple quadrupole)

we are (or will be in a short time) able to offer another range of analyses:

• Nitrosamines in medicinal products
• Drug residues in water

In the longer term:

• Extractable and leachable substances - analyses of plastic packaging of medicines, parts of medical devices (hoses, tubes, bags, etc.)