MUMBAI, India, Aug. 10 -- Intellectual Property India has published a patent application (202641089113 A) filed by Umamaheshkumar Vajrala; and Mithun Rudrapal on July 22, 2026, for A Method For Sec-Mals Molecular Weight Distribution Determination Of Peg-L-Asparaginase.
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 an SEC-MALS method for calibration-independent absolute molecular weight distribution determination of PEG-L-asparaginase drug substance. The method employs an Agilent 1260 Infinity II HPLC system with Shodex KW-803 size-exclusion column, 50 mM phosphate buffer with 150 mM sodium chloride mobile phase at pH 6.8, coupled to a DAWN 8 MALS detector operating at 660 nanometers. Samples are prepared at 1 milligram per milliliter and filtered through 0.22 micrometer PVDF membrane. ASTRA software processes inter-detector synchronized signals using dn/dc of 0.185 milliliters per gram to generate Mn, Mw, Mz, and polydispersity index. BSA standard verification confirms detector normalization with Mw/Mn of 1.004. The method yields Mw values of 1.07 to 1.23 times ten to the fifth daltons and PDI of 1.025 to 1.064, supporting lot consistency evaluation, stability studies, and regulatory comparability assessments for PEG-L- asparaginase quality control.
Disclaimer: Curated by HT Syndication.
