Detection method of trans-1,3-dichloropropene in E-1-chloro-6, 6-dimethyl-2-heptenyl-4-yne
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A technology of dichloropropene and a detection method is applied in the field of medicine and achieves the effects of good specificity, improved medication safety and simple operation
Active Publication Date: 2019-04-05
SHANDONG BOYUAN PHARM CO LTD
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However, after searching, there is no quality control of trans-1,3-dichloropropene in (E)-1-chloro-6,6-dimethyl-2-hepten-4-yne according to genotoxic impurities. literature report
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Embodiment 1
[0040] 1 Instruments and materials
[0041] 1.1 Instrument: TRACE1300 Gas Chromatograph (Thermo Fisher);
[0045] Chromatographic column: 6% cyanopropylphenyl 94% dimethylpolysiloxane column DB-624 (30m × 0.53mm, 3.0μm); column temperature: keep at 80°C for 2min, heat up to 10°C / min Keep at 220°C for 10min; inlet temperature: 250°C; carrier gas: high-purity nitrogen; flow rate: 10ml / min; split ratio: 5:1; injection volume: 1μl;
[0046] Detector: electron capture detector (ECD); detector temperature: 300°C.
[0047] 2.2 Solution preparation
[0048] Blank solution: methanol.
[0049] Control solution: Weigh 30.5mg of trans-1,3-dichloropropene reference substance, put it in a 100ml measuring bottle, add methanol to dilute to the mark, shake well; accurately measure 1ml, put it in a 100ml measuring bottle, add methanol to dilute to the mark , shake ...
Embodiment 2
[0088] Embodiment 2: the detection of actual sample
[0089] Get three batches of (E)-1-chloro-6,6-dimethyl-2-heptene-4-yne samples, prepare contrast solution and need testing solution according to 2.1, 2.2 and 2.3 in example 1 and measure according to law, The result is as follows:
[0090] Table 7 Sample Test Results
[0091] batch number
[0092] .
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Abstract
The invention discloses a detection method of trans-1,3-dichloropropene in E-1-chloro-6, 6-dimethyl-2-heptenyl-4-yne. The detection method comprises the steps that the acceptable limit of trans-1,3-dichloropropene in (E)-1-chloro-6, 6-dimethyl-2-heptenyl-4-yne is determined to be less than or equal to 6 ppm, (E)-1-chloro-6, 6-dimethyl-2-heptenyl-4-yne is subjected to direct sample injection afterbeing dissolved by a solvent, and impurities, namely trans-1,3-dichloropropene, in (E)-1-chloro-6, 6-dimethyl-2-heptenyl-4-yne is subjected to qualitative and quantitative treatment through a GC-ECD detection method. Experiments show that the detection method has the advantages of easy operation, good specificity, sensitivity, accuracy and the like, the impurities, namely trans-1,3-dichloropropene, in (E)-1-chloro-6, 6-dimethyl-2-heptenyl-4-yne can be reliably subjected to qualitative and quantitative analysis according to the control requirements of genotoxic impurities.
Description
technical field [0001] The invention relates to a detection method of trans-1,3-dichloropropene, an impurity in (E)-1-chloro-6,6-dimethyl-2-hepten-4-yne, which belongs to medicine technology field. Background technique [0002] Terbinafine hydrochloride, chemical name: (E)-N-(6,6-dimethyl-2-hepten-4-yne)-N-methyl-1-naphthylmethylamine hydrochloride , is an allylamine drug with broad-spectrum antifungal activity, which can specifically interfere with the early biosynthesis of fungal ergosterol, highly selectively inhibit fungal squalene cyclooxygenase, and make fungal cell membrane formation process The epoxidation reaction of squalene is blocked, so as to achieve the effect of killing or inhibiting fungi. Because of its high lipophilicity and epidermotropic properties, it can also be administered orally for systemic administration except for external use. It is known as the only fungicidal drug without serious liver and kidney adverse reactions. Terbinafine is listed in t...
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