Determination of Epichlorohydrin from Sevelamer carbonate as per proposed USP monograph GC method

User Benefits

- Shimadzu Nexis GC-2030 can be effectively used for limit of Epichlorohydrin test of Sevelamer carbonate drug substance as per the proposed USP monograph GC method. - The Nexis GC-2030 easily meets the acceptance criteria as per the proposed USP monograph for Sevelamer carbonate .

Introduction

Sevelamer carbonate drug substance is intended for oral administration in the treatment of hyperphosphatemia. Sevelamer carbonate acts as a polymeric phosphate binder, and it has been shown to decrease serum phosphorus concentrations in patients with end-stage renal disease. It is known chemically as 2-Propen-1-amine polymer with (chloromethyl)oxirane carbonate. It is poly(allylamine hydrochloride) crosslinked with Epichlorohydrin (ECH). ECH, a bifunctional alkylating agent, chemically described as 2-(chloromethyl)oxirane, belongs to a class of epoxide compounds that are considered to be “probably carcinogenic to humans” based on structure activity relationship. Because of the known carcinogenicity and structural alert for genotoxicity. The presence of residual ECH in Sevelamer carbonate drug substance must be controlled, this led United States Pharmacopeia (USP) to incorporate a gas chromatography procedure named “Limit of Epichlorohydrin” in the proposed new monograph for Sevelamer carbonate. Nexis GC-2030, Key features - Tool-free Column Installation - One-Touch Inlet Maintenance - Remote Operations and Monitoring - Achieves Exceptional Reproducibility (AFC with CPU) - Best-in-class sensitivity for most of the detectors

January 24, 2023 GMT