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As many of you are aware, USP General Chapters <232>/<233> will take effect January 1, 2018. These pertain to Elemental Impurities in all drug products, and many of our previous blogs, videos and website content have been dedicated to this topic, given the importance of compliance. Over the course of this year, we’ve worked with… Read More >
Given the current and pending changes to the USP General Chapters <232><233>, there has been much discussion and activity with respect to validation – or verification – of testing methods, as method validation must be specific to the matrix and elemental impurities within a given product or ingredient. SGS has conducted… Read More >
The USP has fully promulgated the regulations for testing for elemental impurities in drug products, which will take full effect in January 2018. We’ve explored these regulations in past blog posts including Changes to Testing for Elemental Impurities in Drug Products, Risk Assessment for Elemental Impurities in Drug Products and Extractables & Leachables – Elemental… Read More >
Most are aware that the packaging for pharmaceuticals must be free of unwanted impurities. Not only do we wish to understand levels of impurities from a toxicological standpoint; but also, from the perspective of ensuring that the materials found within the packaging do not negatively impact the active ingredients (APIs) within the finished product. This… Read More >
As we noted in our last blog, the USP has fully promulgated the regulations for testing for elemental impurities in drug products, effective January 2018. ICH Q3D advocates the use of a risk-based approach to assessing the potential for the presence of elemental impurities in drug products. It is the responsibility of pharmaceutical manufacturers to… Read More >
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… Read More >
