Tools for Easier Compliance

Starna offer several Instrument Qualification Kits to assist with the qualification of a UV-Visible Spectrophotometer in the ultraviolet region of the spectrum. 

United States Pharmacopeia (USP) Instrument Qualification Sets

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The United States Pharmacopeia Chapter <857> (May 2015) gives new recommendations for the qualification of ultraviolet and visible spectrophotometers, including tests for:

  • Absorbance accuracy and linearity
  • Wavelength accuracy
  • Stray light (new test  procedure)
  • Resolution (new qualification requirement)

The new procedures became mandatory from 1st May 2016. These Starna Qualification Sets contain a number of Certified Reference Materials required to perform these tests.

More information

 

European Pharmacopoeia (EP) Instrument Qualification Sets

 European USP

These sets contain Starna Certified Reference Materials (CRMs) approved by the European Pharmacopoeia (Chapter 2.2.25) for checking:

  • Photometric accuracy and linearity
  • Wavelength calibration
  • Stray light
  • Resolution
  • Resolution (derivative spectroscopy)

These sets also comply with the requirements of several other regulatory authorities, including:

  • European Pharmacopoeia (Ph. Eur), EP
  • American Society for Testing and Materials, ASTM
  • British Pharmacopoeia, BP
  • Deutsches Arzneibuch (German Pharmacopoeia), DAB
  • Therapeutic Goods Administration (Australia), TGA
  • Japanese Pharmacopoeia, JP
  • Pharmacopoeia of the Peoples Republic of China, PPRC

 

More information

 

Combined USP and EP Instrument Qualification Sets

 

Combined USP

These sets contain Starna Certified Reference Materials (CRMs) complying with both USP and EP requirements, and will be useful for laboratories in the international environment and for service and support operations. 

Further information