Many organic impurities, such as nitrosamines, are known to be harmful to human health. Therefore, regulatory bodies and government set strict limits to protect us all. Even in small quantities, pharmaceutical impurities can have serious negative health impacts and influence the behaviour and efficacy of a drug. Organic impurities fall into a number of categories.
Tag: Chemical impurity advice
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