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Safety & Health Research Laboratories
Pharmaceutical analysis and stability testing

We provide pharmaceutical analysis and stability studies according to ICH guidelines.

Our special expertise
  • Development of analytical methods
  • Validation of methods
  • Stability studies on raw materials, active pharmaceutical ingredients and pharmaceutical products
  • Accelerated and long term stability studies
  • Photostability studies
  • Analytical control of batches
  • Specific studies on Dry Powder Inhalers (DPIs) and Metered-Dose Inhalers (MDIs): Cascade Impactor, Next Generation Impactor (NGI).

CIT


Techniques and Equipment
The laboratory has state-of-the-art techniques and equipment including:
  • HPLC: coupled with UV/Vis, DAD, fluorescence, electrochemical detection
  • Automatic TLC system
  • Karl Fisher
  • Loss on drying
  • Other specific equipment is used regularly: LC-MS/MS: Applied Bio Systems, three API 2000 / API 4000 (triple quadruple), GC-MS: coupled with ECD, FID and TSD, or GC-MS Varian Saturn 2000.
CIT equipement


Storage Facilities We have developed a special expertise in stability testing, with the following specific equipments:
  • Stability chambers under climatic conditions complying with ICH guidelines
  • Photostability chamber
  • Storage specific conditions on request
  • Permanent computer-controlled and recorded conditions
  • Emergency electric power generator

  Choose a service description
Short term, tolerance and in-vitro toxicology
Genetic toxicology
General toxicology
Reprotoxicology
Carcinogenicity testing
Safety and general pharmacology
ADME and Bioanalysis
Clinical and Histopathology
Genomics
Ecotoxicology
Pharmaceutical analysis and stability testing
Project Management and Regulatory Affairs
 
 
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