Nitrosamine

See the nice infographic prepared by IPEC Federation on the hot topic of Nitrosamine Risk Determination:   THE BACKGROUND N-nitrosamines...

Abstract The mitigation of nitrosamine formation in drug products has been studied and approaches such as using formulations with pH...

In this paper, the authors introduce a method that combines ion exchange chromatography with a easier-to-perform, simpler one-step post-column derivatization...

More than 80 years ago, BASF invented PVPs, and we fully understand their chemistry. We have excipients with low nitrites,...

The trace level quantification of nitrite in excipients and chemicals is of major interest to the pharmaceutical industry due to...

Abstract Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the...

The WHO has published a new draft guideline on considerations for the prevention and control of nitrosamine contamination in pharmaceutical...

1. Introduction The issue of Nitrosamine impurities in drug and excipient manufacturing has become a significant concern for the pharmaceutical...

PRESS RELEASE February 27, 2024, Asahi Kasei Corp. Contributing to lower risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals To...

In summer 2018, drug regulatory authorities first became aware of nitrosamine impurities in a number of medicinal products, including antihypertensives in the...