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Method for detecting volatile impurities of auxiliary material ethanol

A detection method and volatility technology, applied in the field of detection of volatile impurities, can solve problems such as peak asymmetry, resolution not meeting requirements, tailing, etc., and achieve the effect of improving resolution

Pending Publication Date: 2022-05-06
山西诺普生物医药科技有限责任公司
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Problems solved by technology

At present, some pharmaceutical companies have achieved resolution that meets the requirements, but the peak shape is asymmetric and the tailing is serious; some pharmaceutical companies have achieved peak shape symmetry, but the resolution does not meet the requirements

Method used

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  • Method for detecting volatile impurities of auxiliary material ethanol
  • Method for detecting volatile impurities of auxiliary material ethanol
  • Method for detecting volatile impurities of auxiliary material ethanol

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Embodiment Construction

[0021] The embodiment given below intends to further illustrate the present invention, but can not be interpreted as the restriction to protection scope of the present invention, those skilled in the art still belongs to the protection of the present invention to some non-essential improvements and adjustments of the present invention according to the content of the present invention scope.

[0022] 1) Confirmation of resolution

[0023] Compared with the chromatographic conditions of the United States Pharmacopoeia, as shown in Table 1:

[0024] Table 1 chromatographic conditions comparison:

[0025]

[0026]

[0027] Note: G43 stationary phase is 6% cyanopropylphenyl, and 94% dimethylpolysiloxane is the stationary liquid.

[0028] After comparing the chromatographic parameters, it can be seen that the variables in the chromatographic conditions of the Chinese Pharmacopoeia include the specifications of the chromatographic column, column flow rate, split ratio, and ty...

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Abstract

The invention relates to the technical field of medicine analysis and detection, and discloses a method for detecting volatile impurities of an auxiliary material ethanol. According to the method, the following chromatographic conditions are used: a chromatographic column DB-624 is 30m * 0.32 mm * 1.8 [mu] m; the initial temperature is 40 DEG C and is maintained for 12 minutes, and the temperature is increased to 240 DEG C at the speed of 10 DEG C per minute and is maintained for 10 minutes; the temperature of a sample inlet is 200 DEG C; the temperature of a detector is 280 DEG C; the carrier gas is helium; the sample injection volume is 1 microliter; the split ratio is 20: 1; the column flow is 35 cm / min. And additional condition optimization: the liner tube is an original non-shunting liner tube. According to the method, the separation degree of acetaldehyde and methanol can be greatly improved, and the problem that a benzene impurity peak is not detected is solved.

Description

technical field [0001] The invention relates to the technical field of drug analysis and detection, in particular to a method for detecting volatile impurities of ethanol as an auxiliary material. Background technique [0002] At present, the volatile impurities of ethanol are mainly tested by the inspection method of "Chinese Pharmacopoeia" 2020 edition, but the separation degree of acetaldehyde and methanol is poor in system applicability (standard: not less than 1.5), usually 0.6-1.3. And it is difficult to meet the requirements, and it is not stable. In addition, the response values ​​of the peak areas of each impurity were small, and even some impurity peaks could not be detected by the control peak. Pharmaceutical companies usually use capillary columns DB-624 (30m×0.53mm×3.0um), DB-624 (30m×0.32mm×1.8um), Rtx-624 (30m×0.53mm×3.0um) and AT.ov- 1301 (30m×0.32mm×0.25um), the column flow rate is not the same. At present, some pharmaceutical companies have achieved the ...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/52G01N30/54
CPCG01N30/02G01N30/52G01N30/54G01N2030/025
Inventor 杨铭冀
Owner 山西诺普生物医药科技有限责任公司
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