The acceptable limit for impurities in Nirmatrelvir is determined by regulatory agencies such as the FDA, EMA, and ICH. The limit varies depending on the impurity and its potential impact on the drug’s quality, safety, and efficacy.

Impurities in Nirmatrelvir are controlled during the manufacturing process by implementing good manufacturing practices (GMP) and using appropriate analytical methods for impurity identification and quantification. Purification techniques such as crystallization, distillation, and chromatography to remove impurities.

A genotoxic impurity in Nirmatrelvir is an impurity that has the potential to cause genetic mutations or other genetic damage. Regulatory agencies have strict limits for the presence of genotoxic impurities in pharmaceuticals due to their potential carcinogenicity.

Nirmatrelvir impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).