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Quality Control with highest standards

Our modern laboratory meets the high demands of the government of Upper Bavaria, the FDA and TÜV Süd (Medical Devices Act). With our team of highly qualified doctors, pharmaceutical experts and chemists, we benefit from profound expertise and years of experience in pharmaceutical analytics. On this basis, we can continuously manufacture and analyse your products and our own according to highest standards.

 

Our services 

  • Release testing according to the pharmacopoeia or your customer-specific requirements
  • Method development and validation according to ICH guidelines
  • Stability management: planning and execution of stability testing, analysis and reporting with storage in separate climate chambers under “ICH conditions” for long term, intermediate and accelerated stability studies
  • Process validations and cleaning validations
  • Generation of work instructions, test instructions, test plans and reports

 

Cutting-edge technology for analytics

  • Gas chromatograph (FID)
  • HPLC systems with UV and diode array detectors
  • Capillary electrophoresis
  • Ion chromatograph
  • Photometer
  • Infrared spectrometer (FTIR)
  • Total organic carbon (TOC)
  • Various pharma-specific standard test instruments, for instance to determine disintegration time, drug release or suppository breaking strength