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Indirect determination method for impurity content in torasemide injection

A technology for torasemide and impurity content, applied in the field of indirect determination of impurity content in torasemide injection, can solve problems such as risk, increased impurities, and safety, and achieve strong specificity, quality assurance, and sensitivity high effect

Pending Publication Date: 2022-05-13
江苏睿实生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The Chinese patent application with publication number CN101007003A discusses that torasemide is unstable to heat and easily produces degradation impurities, resulting in increased impurities, and is also prone to produce elemental impurities, which has safety risks

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  • Indirect determination method for impurity content in torasemide injection
  • Indirect determination method for impurity content in torasemide injection
  • Indirect determination method for impurity content in torasemide injection

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Embodiment Construction

[0040] In order to make the purpose, technical solutions and advantages of the present invention more clear, the present invention will be further described in detail below in conjunction with the examples, so that those skilled in the art can fully understand the technical content of the present invention. It should be understood that the following examples are used to further illustrate the present invention, and should not be interpreted as limiting the protection scope of the present invention. Some non-essential improvements and adjustments made by those skilled in the art according to the above contents of the present invention all belong to the protection of the present invention scope. The specific process parameters and the like in the following examples are only examples of suitable ranges, that is, those skilled in the art can make a selection within a suitable range through the description herein, and are not limited to the specific values ​​exemplified below.

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Abstract

The invention provides an indirect determination method for impurity content in a torasemide injection, which is characterized in that the amount of impurity F is determined by directly determining the reduction amount of polyethylene glycol 400 and the content of formaldehyde in the torasemide injection through headspace gas chromatography. Through analysis, generation of PEG400 and formaldehyde in the technological process is effectively monitored in the production of the torasemide injection. According to the method, the content of formaldehyde in the polyethylene glycol 400 and torasemide injection is detected by headspace gas chromatography; the headspace gas chromatography is adopted, derivatization is not needed, a quartz capillary column, temperature programming, nitrogen serving as carrier gas and a flame ionization detector are used, and the method is easy to operate, high in specificity, high in sensitivity, low in control cost and capable of being used for quantitative analysis.

Description

technical field [0001] The invention belongs to the technical field of preparation and detection of torasemide injection, and in particular relates to an indirect determination method for impurity content in torasemide injection. Background technique [0002] Torsemide is a pyridine-sulfonylurea loop diuretic, its chemical name is 1-isopropyl-3-[(4-m-tolylamino-3-pyridyl)sulfonyl]urea, molecular formula: C 16 h 20 N 4 o 3 S, molecular weight: 348.43. The structural formula is: [0003] [0004] Torsemide belongs to the high-efficiency loop diuretics of the pyridine amide urea class. Torsemide has a wide range of indications, a rapid, strong and long-lasting diuretic effect, and a low incidence of adverse reactions. It is a class of high-efficiency diuretics commonly used in clinical practice today. [0005] Torsemide injections on the market usually include solubilizers (polyethylene glycol 400, PEG400), stabilizers (tromethamine), pH regulators (sodium hydroxide) an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/68G01N30/86
CPCG01N30/02G01N30/06G01N30/68G01N30/8679
Inventor 苗艳张戎睿梁志寿高慧丽
Owner 江苏睿实生物科技有限公司
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