Over the last year we have seen a substantive shift in terms of the type / nature of N-Nitrosamines we have seen, moving from the process related small simple dialkyl N-Nitrosamines seen in Valsartan, such as NDMA / NDEA, to API like N-Nitrosamines. Our knowledge is such that we now have a good understanding of
Written By: Dr Andrew Teasdale
Listen to a discussion between Dr Trevor Laird and Dr Andrew Teasdale concerning Impurities. Listen to the Audio Interview by Clicking HERE.
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
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
