Impurities – How Do You Combat Those Elusive Threats?

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. They can be degradants of the drug API or starting materials, unintended by-products of the manufacturing process or untransformed production intermediates. An API failing to separate from other materials involved in its synthesis – such as unreacted starting materials or intermediates – is just one example. Impurities also occur when the by-products formed during synthesis do not completely separate from the active compound.

Instability in pharmaceuticals can also cause organic impurities to develop through API degradation over time. The FDA’s ranitidine recall for example, hinged on mounting evidence of a heat-unstable API.

Dr Andrew Teasdale is a re-knowned impurities expert and published author on the subject with over 30 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. Currently, he chairs AstraZeneca’s Impurity Advisory Group. With over 50 scientific papers published, he has also written 3 books on impurity related matters.

Andrew has also advanced a number of key scientific advancements in the control of impurities as the inventor of the purge factor concept and the instigator of the development of Elemental Impurities database for excipients.

By providing a holistic understanding of the challenges and issues associated with implementing an effective control strategy for all impurity types, Andrew helps chemists examine key areas, specifically, impurity qualification, mutagenic impurities, elemental impurities, extractives and leachables and solvents. Andrew highlights practical approaches through both case studies and practical exercises. He is also able to provide you with clarity as to the current and emerging regulatory frameworks.

He will be talking in particular about the issue of N Nitrosamines, aiming to provide the most up to date assessment of the risk, the guidance framework and most importantly how to ensure control over N Nitrosamines.

We are very pleased to be working with Andrew on impurities training courses and you can find out about his next online training course by clicking here.