Method Development, Validation and Transfer

We have a comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, APIs, intermediate products and finished products, according to the ICH Q2 (R1) in line with Q6A and Q6B. Our methods are ready for transfer to contract-giver, in compliance with EU-GMP chapter 6, performing a comparative test, a co-validation in two sites or a revalidation.

img_9618_0.jpg

Analytical methods available:

  • Identification
  • Assay testing
  • Related Substances
  • Residual Solvents
  • Elemental impurities
  • Genotoxic impurities
  • Dissolution
  • Stability indicating methods
  • Leachables and extractables
  • Cleaning and process validation

HPLC reduced_1.jpg

The parameters to be included in the method validation are the following:

  • Accuracy
  • Precision (repeatability, intermediate precision, reproducibility)
  • Specificity
  • Detection limit
  • Quantitation limit
  • Linearity
  • Range
  • Robustness
  • System suitability test

 

CONTACT US
 

Tel. +34 935 481 848

 

 

 

Contact form

Files must be less than 2 MB.
Allowed file types: pdf doc docx odt.