Validations & Verifications for Elemental Impurity Testing

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. Chemical Solutions, Ltd. (CSL) has conducted validations… Read More >

elemental impurity testing

Dermal Administration in Elemental Impurity Testing

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 >

Extractables and Leachables

Extractables & Leachables – Elemental Impurity Testing

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 >

Elemental Impurities in Drug Products

Risk Assessment for Elemental Impurities in Drug Products

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 >

Elemental Impurities in Drug Products

Changes to Testing for 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… Read More >

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