Simultaneous Analysis of Nitrate and Nitrite Ions in Pharmaceutical Additives

User Benefits

- Nitrite and nitrate ions contained in pharmaceutical additives can be determined with simple pretreatment procedure. - High-sensitivity analysis on the order of µg/L can be performed using UV detector. - Employed instrument setup can be applied to multipurpose anion analysis using suppressor-based ion chromatography.

Introduction

Since 2018, efforts have been underway in various countries to reduce the risk of nitrosamines contamination, originated by the detection of nitrosamines, a carcinogenic substance, in pharmaceutical products in Japan and other countries and following recall or discontinuation of certain pharmaceutical products. Nitrosamines are known to be formed by the reaction of amines with nitrite. It has been reported that nitrous acid added for the purpose of inactivating azide compounds used in synthetic process and nitrites presenting as impurities in reagents and excipients raise a risk for the formation of nitrosamines. For this reason, the US FDA guidance and EP monograph also refer to the analysis of nitrite as an impurity.

November 6, 2023 GMT