Hydrazine hydrate and hydrazine compounds are often used as reducing agents or nitrogen source intermediates in the process of drug synthesis. These substances may remain in the end products and become impurities, which will strongly stimulate human organs such as eyes and upper respiratory tract, damage liver, kidney and myocardium, and lead to cancer and genetic damage due to their carcinogenicity and teratogenicity. Therefore, if drugs contain hydrazine hydrate and hydrazine compound residues, drugs will have quality defects and pose a threat to human health. It is particularly important to establish a rapid, sensitive, accurate and reliable analytical method to control the content of hydrazine hydrate and hydrazine compounds in drugs in the development process of human medicine.

The main characteristic of genotoxic impurities is that they can cause damage to human genetic material at very low concentration, lead to gene mutation and promote tumor occurrence. Because of its strong toxicity, it poses a strong threat to the safety of drugs. There have been many cases of forced recall of listed drugs due to non-compliance in the control of genotoxic impurities in the industry, which has caused huge losses to enterprises. Therefore, today, when individuals pay more attention to their own health and the review institutions pay more attention to the verification of drug quality compliance, how to better use the concept of QBD to control the content of genotoxic impurities in drugs and reduce costs to the greatest extent has become one of the compulsory courses for enterprises today.