LOWER LEVEL DETERMINATION OF EPICHLOROHYDRIN CONTENT IN DRUG SUBSTANCE BY USING DIMETHYL SULFOXIDE AS AN INTERNAL STANDARD WITH GAS CHROMATOGRAPHY

摘要

Epichlorohydrin is an extremely versatile chemical intermediate or raw material that is used in a wide variety of drug substances, it can occur in final products at concentration, which are hazardous to human health. This article presents an analytical technique to determine the concentration of epichlorohydrin in final drug substance, in response to the requirements of the drug regulatory, which recommends limiting the concentration to maximum of 75 mcg/g.The instrument platform used for the low-level determination of epichlorohydrin in final drug substance was the Shimadzu gas chromatograph 2010. The typical limit of quantitation of the method determined 4.56 mcg/g and limit of detection was 4.10 mcg/g. The system was successfully calibrated across a working range of 4.56 mcg/g to 10.0 mcg/g with a linear calibration curve.