A method for detecting residual solvents in moxifloxacin hydrochloride bulk drug
This study utilizes headspace gas chromatography (HGC) to achieve rapid and accurate detection of residual amounts of 10 solvents—methanol, petroleum ether, ethanol, isopropanol, acetonitrile, dichloromethane, ethyl acetate, methyl isobutyl ketone, toluene, and DMF—in moxifloxacin hydrochloride raw material. This method solves the problem of existing technologies being unable to simultaneously detect these solvent residues. It enables the detection of residual amounts of methanol, petroleum ether, ethanol, isopropanol, acetonitrile, ethyl acetate, toluene, and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride, which is not applicable to existing technologies in the production process of moxifloxacin hydrochloride.
Patent Information
- Application Number
- CN201911337272.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2019-12-23
- Publication Date
- 2026-07-17
AI Technical Summary
Existing technologies cannot simultaneously and rapidly detect the residual amounts of several solvents, including methanol, petroleum ether, ethanol, isopropanol, acetonitrile, dichloromethane, ethyl acetate, methyl isobutyl ketone, toluene, and N,N-dimethylformamide, in moxifloxacin hydrochloride raw materials. Furthermore, existing technologies are not applicable to methods for detecting the residual amounts of these 10 solvents in moxifloxacin hydrochloride raw materials, nor are they applicable to methods for detecting the residual amounts of toluene and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride.
A headspace gas chromatography method was adopted to detect the residues of toluene and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride. Existing technologies are not applicable to the detection of toluene and N,N-dimethylformamide residues in the production process of moxifloxacin hydrochloride.
This invention enables the detection of several residues, including methanol, petroleum ether, ethanol, isopropanol, acetonitrile, ethyl acetate, toluene, and N,N-dimethylformamide, in the production process of moxifloxacin hydrochloride. Existing technologies are not applicable to methods for detecting the residues of toluene and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride.
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