Chemical characterization of leachable, extractable, impurities, degradation and forced degradation product from medical devices, drug products and drug substances

  • Identify and quantitation of leachable and extractables from medical devices in accordance to ISO 10993-18, to support the joint program with 2SD Toxicology Services verifying the Biocompatibility of Medical Devices and components that make up these devices.
  • Identification and quantitation of forced degradation products from hydrolysis (acid – base) , photolysis, thermal, oxidation from drug substances and drug products.
  • Stability studies on drug substances and drug products, according to ICH guidelines at 40C, 25C, -20C and -80C and identifying and quantifying the products detected.
  • Determine drug potency by bioassays during stability study and after forced degradation studies