PHARMACEUTICAL

Pharmaceutical industry

InKemia IUCT group has been authorized by the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for medicinal drugs and Sanitary Products) as a pharmaceutical laboratory for drug production  (4155-E)

 

Control of pharmaceutical products

  • Assay
  • Impurities
  • Related substances
  • Residual solvents
  • Dissolution rate
  • Identification
  • Viscosity
  • Heavy metals
  • Humidity
  • Microbiological control
  • Endotoxins
  • Assay by microbiological method: antibiotic assessment, determination of B12 vitamin
  • Any other specified by the product

 

Water control

  • Purified water assays according to Pharmacopeia specifications
  • Potability

 

Surface and environmental control in production rooms

 

Isolation, purification and identification of products and impurities

 

DMF development

  • Analytical and experimental support
  • Structure and drafting support

Control of products in development

    • Preservative challenge testing
    • Ames test

Analytical methods

      • Design and set up of methods for physicochemical and microbiological analysis
      • Method validation according to ICH

Stability studies of pharmaceutical products

      • Protocol drafting for stability studies
      • Sample storage in climatic chambers according to ICH conditions
      • Analytical control
      • Report drafting of the stability study

For any inquiry regarding activities not listed do not hesitate to get in contact with us.

Contact

  •   info@inkemia.com
  •  +34 93 579 34 32
  •  +34 93 570 57 45
  •  C\ Àlvarez de Castro, 63, 08100
    Mollet del Vallès (Barcelona)