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The Phantom Menace

When I started my PhD one of my then colleges spent months trying to make something that was sitting on a shelf in the chemical store room less than ten feet from their bench. Could there really be anything more frustrating? Well yes there could. Imagine finding a new catalytic process or synthetic transformation only

Why does the management of impurities scare people?

A recent survey suggested that out of all CMC topics the one at the forefront of many people’s minds and concerns is that of impurity control.  Why might that be the case? After all there is a strong framework provided by ICH in the form of ICH Q3A / Q3B (Impurities in drug substance and

Purge Factor Calculations – in ICH Quality Guidelines

ICH M7 provides greater flexibility to assess the risk posed by Mutagenic Impurities.  This is described in section 8 – Control of the guideline and defined as a series of control options.  Of these Option 4 permits an applicant to present an argument for control based on the physico-chemical properties of a mutagen and the

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