ICH M7(R2) utilizes the Threshold of Toxicological Concern (TTC) to define the acceptable intake of any uncharacterized chemical that can possibly cause a risk of carcinogenicity or other toxicity. Acceptable TTC based intake of an impurity is 1.5 µg per person per day and generally this concentration can be used for most pharmaceutical products to derive an acceptable limit of control. In addition, an acceptable intake will depend upon different clinical scenarios to include treatment duration.
Understanding your impurities early in the drug development process will facilitate implementation of controls and monitoring. Primera Analytical Solutions works closely with our clients to understand their impurity risk assessment, conduct degradation studies and develop an analytical program that is both phase appropriate and cost effective. We have the ability to work from early phase development to commercialization of the product.
Primera’s approach to genotoxic impurity testing is comprehensive. We have positioned ourselves to be able to handle all genotoxic impurities to include highly potent and highly carcinogenic materials, such as Nitrosamines. Our high containment suite contains all necessary equipment to handle these materials. We maintain a highly trained staff and provide all necessary personal protective equipment to successfully complete a study.
Genotoxic impurity testing requires the use of state of the art instrumentation because low detection levels, ranging from single digit ppb to a few hundred ppm level based on a specific API and/or finished product. Primera utilizes a variety of instrumentation to conduct genotoxic impurity method development and perform phase appropriate validation: