MUMBAI, India, Sept. 28 -- Intellectual Property India has published a patent application (202521024434 A) filed by Fdc Limited on March 19, 2025, for A Method For Reducing Nitrosamine Drug Substance-Related Impurities (ndsris) In A Pharmaceutical Composition.
Inventors include Nandan Mohan Chandavarkar; Dr. Jitendra Jaikumar Gangwal; Pragati Kaustubh Rane; and Sagar Panditrao Patil.
The application for the patent was published on September 25, 2026, under issue no. 39/2026.
Abstract: The present invention relates to a method for reducing nitrosamine drug substance-related impurities (NDSRIs) in a pharmaceutical composition by reducing the amount of nitrates and nitrites present in hydroxyethyl cellulose (HEC), a commonly used pharmaceutical excipient. The method involves purification of HEC using a water miscible, polar solvent in which HEC is insoluble. Purified HEC, when added to a pharmaceutical formulation significantly reduces the amount of Nitrosamine Drug Substance-Related Impurities (NDSRIs) in the formulation.
Disclaimer: Curated by HT Syndication.
