Release time:

2020-12-14

Source:

Author:

North Branch Temple

Residual solvents in pharmaceuticals refer to organic solvents used in the production of APIs or excipients, as well as in the preparation of formulations, but not completely removed during the process. The residual solvents of chlorphenamine maleate are mainly tetrahydrofuran, dioxane pyridine and toluene. According to the headspace-capillary column gas chromatography method for the determination of residual solvent of chlorphenamine maleate specified in the national standard "Chinese Pharmacopoeia" (2010), the TP-6000 all-energy headspace sampler developed and produced by Beijing Beifentianpu Instrument Technology Co., Ltd. was used to carry out the experiment on this specification. The experimental results showed that the components in 4 were determined within 11min and had good separation effect. The RSD% of the four components in precision experiment was less than 5%, in line with the national standard "Chinese Pharmacopoeia" (2010); Conclusion: TP-6000 all-round headspace sampler than conventional water bath heating and sampling analysis: high degree of automation, simple and convenient, good reproducibility, improve the sensitivity, suitable for the detection of residual solvent content in drugs.