Advances in Pharmaceutical Science & Translational Research Feb 26, 2026

Determination of residual cyclopropane in carboxymethyl cross-linked starch hemostatic granules

Hongmei Li
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Abstract

This study established a headspace gas chromatography method for determining the residual amount of epichlorohydrin in carboxymethyl cross-linked starch hemostatic granules. Using Agilent DB-624(30 m x 530 μ m x 3.0 μ m) capillary chromatography column, the column temperature is programmed heating(50 ℃ for 2 minutes; 50 ℃/min for 180 ℃ for 5 minutes), the inlet temperature is 200 ℃, the detector temperature is 250 ℃, the carrier gas is N2, the flow rate is 3 mL/min, and the separation ratio is 3:1. The relative standard deviation of precision is 1.22%; The concentration of epichlorohydrin is 0.84~6.72 μ g/mL, and its peak area has a good linear relationship with concentration, with a correlation coefficient of 0.9997; The detection limit is 0.336 μ g/mL, and the quantification limit is 0.84 μ g/mL; The average recovery rate is 101.7% (n=9). This method has good reproducibility, high sensitivity, and is simple and accurate.

Keywords

carboxymethyl cross-linked starch Hemostatic granules Gas chromatography method Residual epichlorohydrin testing.

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