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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.
We use quantitative NMR spectroscopy as our analytical method. The advantages of this method are:
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. Ein zertifizierter Standard sollte also bezüglich der Rückführbarkeit Informationen enthalten, wie ein bestimmter Wert durch Vergleich mit anderen Materialien abgesichert wurde. We trace the content of your work standard back to SI.
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:
Mass spectrometry:
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!
