Changes to Testing for Elemental Impurities in Drug Products

Elemental Impurities in Drug Products

As most industry professionals are aware, the USP has fully promulgated the regulations for testing for Elemental Impurities in drug products. This will take full effect in January 2018, replacing the century-long methodology for testing for heavy metals.

Upon implementation, the use of the older USP <231> methodology will no longer be acceptable for existing USP monographed materials.    Drug products covered under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) prior to that time may be subject to the new Elemental Impurities requirements  as defined in General Chapters <232> and <233> even sooner.

Chemical Solutions has been utilizing the technologies of ICP-OES and ICP-MS for nearly two decades.   During that time we have garnered extensive knowledge of testing impurities in nutritional supplements and complex consumer products that we are now applying to these new regulations and pharmaceutical products.  Our arsenal of 5 ICP-MS instruments include the augmented services of kinetic energy dispersion (KED) and dynamic reaction cell technologies (DRC) which enables us to test for varying levels of elements within very complex products.

We’ve helped to develop protocols for our clients in the pharmaceutical and nutritional supplement industries, as well as excipient manufacturer’s groups, so they can employ elemental impurities testing in an efficient and reliable manner.

Want to know more about how to prepare for this change? Watch our video on elemental impurities and stay tuned for our next blog on validation.

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