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Method for determining moisture limit of cefazedone sodium sterile

A kind of technology of cefoxidone sodium and determination method, which is applied in the field of determination of water limit of cefoxidone sodium, and achieves the effects of ensuring stability and safety, and the method is simple and easy to operate

Inactive Publication Date: 2013-02-06
天津新丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Therefore, reducing and controlling the water content in cefazedone sodium crystals is of great significance to the stability of the product and the final clinical efficacy. Determining moisture limits, other than that, there is no more straightforward and easy way

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  • Method for determining moisture limit of cefazedone sodium sterile
  • Method for determining moisture limit of cefazedone sodium sterile

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Embodiment Construction

[0037] The present invention will be further described in detail below through the specific examples, the following examples are only descriptive, not restrictive, and cannot limit the protection scope of the present invention with this.

[0038] A method for determining the water content control limit of cefazedone sodium, the steps are as follows:

[0039] 1. Sample

[0040] Cefazedone sodium for injection, batch number: 110304, 110305, product of Tianjin Xinfeng Pharmaceutical Co., Ltd. The raw materials are all cefzidone sodium produced by South Korea Shinfeng Pharmaceutical Co., Ltd.

[0041] 2. Measurement method

[0042] ⑴ Determination of water activity

[0043] Adopt AW SPRINT type water activity measuring instrument, the product of Swiss Novasina company; basic parameter setting: measuring temperature is 25 ℃; humidity stability factor is 2; calibration relative humidity points before testing are 3, respectively 11.3%RH, 52.9% RH, 75%RH; take a proper amount of s...

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Abstract

The invention relates to a method for determining a moisture limit of cefazedone sodium sterile. The method comprises the steps of: (1) measuring water activity of a cefazedone sodium sterile sample; (2) measuring a moisture content of the cefazedone sodium sterile sample; and (3) drawing a correlation curve of the water activity and the moisture content through the two values and finally determining the moisture control limit of the cefazedone sodium sterile. By measuring the moisture content in the cefazedone sodium sterile solid and the water activity thereof, drawing an isothermal adsorption curve of the cefazedone sodium sterile sample and determining the moisture control limit of the cefazedone sodium sterile based on the relationship between the two indexes, the invention provides a method for determining the moisture limit more simply and more directly.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for determining the water limit of cefazedone sodium. Background technique [0002] Cefoxitone Sodium is the first generation cephalosporin researched and developed by E.Merck, Darmstadt laboratory. In 1979, E.Merck was the first to go on the market in Germany, and then in its surrounding areas and South Korea, Romania, Bulgaria, Taiwan, etc. Listed in countries and regions, its English name is Cefazedone Sodium; chemical name is (6R,7R)-7-(2-(3,5-dichloro-4-oxo-1(4H)-pyridyl)acetamido) -3-(((5-methyl-1,3,4-thiodiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0 ] Sodium oct-2-ene-2-carboxylate. [0003] Its chemical structural formula is: [0004] [0005] The above structure of cefoxitone sodium is similar to that of cefazolin sodium, both of which are β-lactam antibiotics. [0006] Cefoxizone sodium against Staphylococcus aureus, coagulase-negative staphy...

Claims

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Application Information

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IPC IPC(8): G01N33/15
Inventor 李章才高朝阳刘文玖林澜许龙哲崔连泉
Owner 天津新丰制药有限公司
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