Phone: +49 3672 379 - 0

Ostthüringische Materialprüfgesellschaft für Textil und Kunststoffe mbH

Pharmaceutical analyses

As a GMP laboratory continuously monitored by competent authority, we guarantee a high level of precision and competence in the analysis of pharmaceutical base materials, intermediates, semifinished products and finished products. Our current GMP certificate shows an overview of the accredited methods  according to §14 (4) of the German Medical Products Act (AMG). Additionally, regular audits by pharmaceutical companies and FDA confirm the compliance of our work with the GMP requirements.

Pharmaceutical analyses

  • Chemical-physical tests in compliance with all common pharmacopoeias:
    • European Pharmacopoeia (Ph. Eur.)
    • U.S. Pharmacopeia (USP)
    • Japanese Pharmacopoeia (JP)
    • British Pharmacopoeia (BP)
  • Tests in compliance with the German Pharmacopoeia (DAB)
  • Analyses in compliance with customer-specific test instructions
  • Validation of analysis methods for:
    • Assa
    • Purity testing
    • Limit and residue testing
  • Stability testing
  • Identity testing
We will gladly support you in the analytics of other issues with our analytical know-how.

Test methods:
  • Atomic spectroscopy: Graphite  furnace AAS, flame AAS, FIAS hydride AAS, Hg cold vapour AAS, ICP-OES
  • Molecular spectroscopy: IR, UV / VIS
  • Thermal analyses: TGA, TGA-IR coupling, DSC
  • IC with conductivity detection
  • X-ray fluorescence analysis (XRF)

Pharmaceutical analyses

Dipl.-Chem. Anke Krämer
Phone: + 49 3672 379 - 256
Fax: + 49 3672 379 - 379
Email: analytik@ompg.de

Accreditation

OMPG is an accredited testing laboratory according to DIN EN ISO / IEC 17025.

Accreditation certificate (PDF)
Annex to accreditation certificate (PDF)

Contact

Ostthüringische Materialprüfgesellschaft für Textil- und Kunststoffe mbH

Breitscheidstraße 97
07407 Rudolstadt
Germany

Phone: + 49 3672 379 - 0
Fax: + 49 3672 379 - 379
Email: info@titk.de