Quality is a crucial factor at Reference Analytics. Especially in customer support we place the highest value on quality to meet the highest expectations. We make an essential contribution to the quality of medicinal products and create significant added value for our customers.

Development and validation

  • Literature research
  • Development of analytical methods
  • Validation of analytical methods incl.
    • Standard validation
    • Transfer validation
    • Revalidation

Validations are performed according to ICH guidelines and include the following risk-based parameters

  • Specificity
  • Linearity
  • Accuracy
  • Precision
  • Limit of detection
  • Limit of quantification
  • Range
  • Robustness

Method verification

  • Product specific verification of test method

Quality control according to pharmacopoeia (Pharm. Eur., Ph. Helv., USP, …)

  • Complete examination according to monograph
  • Identity check
  • Purity testing
  • Limit testing
  • Assay of content

Further development is an important part of our philosophy, therefore we are constantly expanding our range of services.

If your desired method is not included here, please do not hesitate to contact us!