Qualifying Reference Standards

Referenzstandardqualifizierung

Reference standards form the basis for any good analysis, but not all reference standards can be bought in the required quality.

The requirements laid out in the GMP guidelines are high. The guidelines stipulate the following: “If a primary reference standard is not available from an officially recognized source, an ‘in-house primary standard’ should be created. Appropriate testing should be performed to fully substantiate the identity and purity of the primary reference standard. Adequate documentation of these tests should be retained.”

To ensure that your work standards meet the prescribed quality requirements, we can determine their identity and purity for you. We will create a meaningful test report and take care of archiving the corresponding documents.

Our reference standard qualification services

Quantification

We use quantitative NMR spectroscopy as our analytical method. The advantages of this method are:

  • Relative primary method
  • No special standard required for each analyte
  • High selectivity
  • Quantification possible via the nuclei 1H, 13C, 19F and 31P
  • Multiple analytes can be determined simultaneously
  • Usually no method development needed

Traceability

No method – no matter how precise – is able to provide the true value of a given property. There will always be factors during a measurement that will cause the result to deviate from the true value. That’s why an estimation must be made as to how unreliable the measurement results are. To do this, the measurement result must be traced back to a reference, meaning a certified standard should contain traceability information explaining how a certain value was verified through comparison with other materials. We trace the content of your work standard back to SI.

Identity screening

For identity screening, we have NMR spectroscopy along with high-resolution mass spectrometry and infrared spectroscopy at our disposal. The advantages of these methods are:

NMR spectroscopy:

  • Structural information at the atomic level
  • Ability to distinguish isomers and rotamers

Mass spectrometry:

  • High sensitivity
  • Structural elucidation of trace impurities is generally possible
  • Accurate identification of symmetrical structures
  • Mixtures can also be tested by combining techniques
  • Infrared spectroscopy:
  • Fast, simple, reliable
  • Comparison with reference spectra from a database or pharmacopoeia

All of these studies are conducted to GMP specifications. Our laboratories have been audited many times by the relevant authorities (including the FDA) and customers. Thanks to our extensive experience, we can ensure you don’t fail an official inspection because your reference standards do not meet the prescribed quality requirements. We know what needs to be done. Play it safe and have your standards tested by us!

You can find our current GMP certificate here!

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