Whitepaper | March 2024 | MEGGLE Business Unit Excipients

How to meet challenges in determining trace levels of nitrite in lactose

In MEGGLE´s whitepaper “Risk Mitigation of Nitrosamines formation in Drug Products: Role of Excipients” the important issue of Nitrosamine impurities in drug and excipient manufacturing was explained in detail as this topic has become a significant concern for the pharmaceutical industry and health authorities in the last years. The reason for the update is that MEGGLE invested in the development of a new analytical method to even be able to determine trace levels of Nitrite in Lactose. The new analytical method was successfully validated in cooperation with the Technical University Munich (TUM).

As known excipients may contribute to the formation of Nitrosamines through precursor substances present in the excipient (e.g. nitrites, amines). Therefore it is an important achievement that with the new method also trace levels of Nitrite can be determined in MEGGLE´s large Lactose portfolio.

If you would like to learn more about how MEGGLE can help you mitigate the risk associated with Nitrosamines, please contact us.

Mr. Albert Cowstein (Meggle)

    Nitrosamine Update