N-Nitrosamines; another class of Toxic substances considered probable carcinogens (Potentially genotoxic impurities) for human health.
Interstellar Testing Centre (ITC Labs) has been pioneering to support its business partners for their Testing requirements of contaminants in addition to their other quality control requirements using its advanced technology platform.
N-nitrosamines have been reported in Drug Products, air, water, foods, cosmetics, tobacco, and packing materials. Recently recall of several Angiotensin II receptor blockers (ARB) drugs e.g., Valsartan, Losartan, and Irbesartan made N-Nitroso impurities a focus for regulatory agencies. Nitrosamine impurities in APIs are by products, produced in trace amounts during the manufacturing processes of these medicines.
ITC Labs, has taken a lead in this direction to support related Industries in Risk assessment due to probable sources of additives, water, process impurities, degradants etc., Our Scientists have developed several methods on different matrices and number of Nitrosamine impurities in single run achieving lowest sensitivity using ultra- sensitive analytical techniques.
Our Lab developed and validated methods have been well appreciated & accepted by Industry and concern regulatory authorities not only in country but several European countries.
We are working on 15+ Impurities on regular basis in addition of different Nitrosamine Drug Substance-Related Impurities (NDSRI) while same numbers of these impurities are under development.
We are also supporting in risk assessment, by checking the presence of precursors of N-nitrosamine impurities.
In case you need any support, please do write to us, our team will reach to you;
Dr. Ropak Kumar
Email: roopak.kumar@itclabs.com
WhatsApp: +91 70870 36598
Website: www.itclabs.com