ANALYTICAL DEVELOPMENT FOR RAW MATERIAL AND PHARMACEUTICAL PRODUCTS

InKemia IUCT group has been authorized by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spanish Agency for medicinal drugs and Sanitary Products) to perform quality control of medicines for human and veterinary us, and drugs under research (Nº 4155-E).

InKemia IUCT group also counts with ISO 9001:2008 certification by Lloyd’s Register for the design, research and development of new products, control systems and training for the pharmaceutical, alimentary, chemical and related sectors (Nº SGI 3201316).

 

Physicochemical Methods

Development of analytical methods for the identification, purification and determination of content by means of:

  • Separation and characterization of impurities and degradation products
  • Set up and optimization of methods according to the client’s specific needs.

Validation of methods determining the following parameters among others:

  • Problem solution stability
  • Accuracy
  • Repeatability (accuracy of the method)
  • Intermediate precision
  • Precision
  • Linearity
  • Selectivity
  • Robustness
  • Reproducibility
  • Detection Limit
  • Quantification limit

Microbiological methods

InKemia IUCT group performs the development and validation of the following microbiological methods:

  • Challenge test
  • Microbiological assay for vitamins, antibiotics ...

 

Analytical Techniques