Reference Standard Qualification

During the development of pharmaceutical product, multiple reference standards are required – starting materials, intermediates, final products, impurities…..Brightlabs is able to help with the characterisation of these reference materials and, if required, provide the data needed for a regulatory filing.


Reference Standards may be used for:

  • Impurity identification
  • Impurity quantification
  • API quantification
  • System suitability

Brightlabs is able to support the full process of reference standard qualification:

  • Source the compound, custom synthesized by a partner if required
  • Purify the material if required (eg for primary reference standard purposes) by preparative HPLC
  • Prepare the qualification protocol
  • Perform the experiments
  • Prepare a Qualification Report and calculate Potency
  • Store appropriately, dispense when required and periodically retest


Different kind of standards:

  • Retention time markers
  • Working standards
  • Primary reference materials