MUMBAI, India, Aug. 10 -- Intellectual Property India has published a patent application (202641089136 A) filed by Umamaheshkumar Vajrala; and Mithun Rudrapal on July 22, 2026, for A Method For Gc-Ms/Ms Simultaneous Determination Of Nitrosamine Impurities In Octreotide Acetate.
Inventors include Umamaheshkumar Vajrala; and Mithun Rudrapal.
The application for the patent was published on July 31, 2026, under issue no. 31/2026.
Abstract: The present invention discloses a validated GC-MS/MS method for simultaneous quantitative determination of NDMA, NEIPA, and NDIPA nitrosamine impurities in octreotide acetate drug substance. The method employs an Agilent 7010B GC-MS/MS system with a DB-624 capillary column, helium carrier gas, dimethyl sulfoxide diluent, and headspace sampling with electron ionization multiple reaction monitoring detection. NDMA, NEIPA, and NDIPA are resolved at retention times of 4.9, 7.4, and 8.3 minutes respectively. Validation per ICH Q2R1 and USFDA guidelines demonstrates excellent linearity with correlation coefficients of 0.9878, 0.9958, and 0.9929, limits of quantification of 0.2205, 0.9458, and 3.6775 ppm, mean recoveries within 92.6 to 110.2 percent, and method precision percentage relative standard deviation values below 5 percent for all analytes. The method provides improved sensitivity, enhanced specificity, regulatory compliance, and accurate simultaneous nitrosamine impurity determination for routine pharmaceutical quality control.
Disclaimer: Curated by HT Syndication.
