CHIMAN ON THE FRONT LINE IN GENOTOXIC IMPURITIES EVALUATION AND DETERMINATION
N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), both classified as probable human carcinogens, were not identified as impurities of Sartan APIs and the same problem was found in Ranitidine HCl drug product.
Sodium azide, Zin Chloride in presence of Dimethyl formamide giving quenching with sodium nitrite transformed it in nitrous acid. Nitrous acid fast reacting with secondary amines gives N – Nitrosamines, classified as human carcinogens.
Chiman has invested in a UPLC – Orbitrap Q Exactive Classic, to be able to detect those impurities at the lowest regulatory level set.
Other API’s and Drug Products are under investigation by the European Medicine Agency and FDA, in order to increase safety and quality of the Medicinal Products potentially contaminated by those impurities.
Chiman Laboratory following evidence of the risk assessment is able to develop methodologies and analytical testing plans in order to sustains risk-based considerations. Chiman quality assurance approach is based on state-of-the-art analytical equipment, completely in accordance with CFR21 requirements.
Following FDA methodologies like FY19-107-DPA-S_LC-MS Method for Detection of Six Nitroso Impurities in angiotensin II receptor blocker Drugs_051619, Chiman can provide UHPLC-ESI-APCI-MS/MS analysis of N-Nitrosamines in API’s and Drug Products by using official methods or customized methods on Client’s needs.
All the methods will be validated according to ICH Guidelines, before their use.
All the regulatory Agencies investigation up-grades will be integrated in Chiman methodologies.