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Drug manufacturers may be required to accelerate or force degradation of a product to demonstrate that it has gone through the stability indicating method. In some cases, QC labs are be able to find background data for the specificity of a method – either from literature or from the supplier of the drug substance. Then, validation is straightforward with the typical parameters listed in the USP in chapter <1225> on validation of compendial methods.

Degradation product levels can be measured by a variety of techniques, including those that compare an analytical response for a degradation product to that of an appropriate reference standard. Acceptance criteria and analytical procedures are often based on analytical assumptions such as equivalent detector response and should be included in the registration application. Differences between the analytical procedures used during development and those proposed for the commercial product should also be included.

Identification and quantification of degradation products (if below ICH threshold levels) require the use of analytical technologies, consumables, and services to make sure your lab is GMP compliant. We provide the tools you need for you to take control of your degradation products testing.