Determination of residual solvent of chlorpheniramine maleate
Residual solvents in drugs refer to organic solvents used in the production of APIs or excipients, and in the preparation of preparations, but which have not been completely removed during the process. The residual solvents of chlorpheniramine maleate mainly include tetrahydrofuran, dioxane and toluene.
According to the national standard "Chinese Pharmacopoeia" (2010) stipulated by headspace-capillary column gas chromatography for the determination of the residual solvent of the drug chlorpheniramine maleate, by using TP- developed and produced by Beijing Beifentianpu Instrument Technology Co., Ltd. The 6000 almighty headspace sampler tested this regulation. The experimental results showed that: 4 components were measured within 11 minutes and had a good separation effect. The RSD% of the four components in the precision experiment were all less than 5%, which was in line with the national standard " "Chinese Pharmacopoeia" (2010) provisions; conclusion: TP-6000 all-around headspace sampler is heated than conventional water bath and then sample analysis: high degree of automation, simple and convenient operation, good reproducibility, improved sensitivity, suitable for testing drugs The residual solvent content.
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