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Method for controlling related substances in ceftezole sodium

A technology of ceftezole sodium and control method, which is applied in the pharmaceutical field, can solve problems such as darkening of color, loss of medicinal value, and poor quality, and achieve the effect of stable product quality and simple and easy quality control methods

Inactive Publication Date: 2014-12-24
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because ceftezole sodium is susceptible to quality changes due to the influence of external environmental conditions, especially the stability is greatly affected by temperature, humidity, light and air conditions, and carelessness during packaging, transportation and storage can easily lead to color changes. Deep, serious deterioration of quality, or even loss of medicinal value, increasing the unsafety of clinical medication

Method used

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  • Method for controlling related substances in ceftezole sodium
  • Method for controlling related substances in ceftezole sodium
  • Method for controlling related substances in ceftezole sodium

Examples

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Embodiment Construction

[0050] The present invention will be further illustrated below by way of examples, but the present invention is not limited thereto. For the experimental methods without specific conditions indicated in the following examples, the conventional conditions or the conditions suggested by the manufacturer are usually followed. The percentages appearing below are all mass percentages.

[0051] The list of materials used is shown in Table 1.

[0052] Table 1

[0053]

[0054] See Table 2 for the operating room and main equipment of each process.

[0055] Table 2

[0056]

[0057] 1. Raw material preparation:

[0058] (1) Check the name, batch number and quantity of raw materials.

[0059] (2) According to figure 2 The process flow shown is for raw material delivery.

[0060] 2. Cleaning and sterilization of soda-lime glass molded injection bottles:

[0061] (1) Soda-lime glass molded injection bottle is unpacked to check the appearance, and after confirming that there...

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Abstract

The invention provides a process for preparing ceftezole sodium for injection and a method for controlling related substances in the process of preparing ceftezole sodium for injection. The method for controlling the quality of ceftezole sodium for injection is simple and feasible, is capable of guaranteeing stable product quality, enables the validity to be 24 months, and is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a quality control method in the preparation process of cephalosporins, in particular to a control method for related substances in ceftezole sodium. Background technique [0002] Ceftezole Sodium for Injection, also known as Yitixin, has a molecular weight of 462.47 and molecular formula C 13 h 11 N 8 NaO 4 S 3 , the chemical name is (6R,7R)-3-{[(1,3,4-thiadiazol-2-yl)thio]methyl}-7-[(1H-tetrazol-1-yl)acetamido ]-8-Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, CAS number 41136-22-5. Its chemical structural formula is as follows: [0003] [0004] Ceftezole sodium is the first generation of cephalosporin antibiotics for injection. It is a semi-synthetic cephalosporin derivative. Its mechanism of action is to exert antibacterial activity by inhibiting the synthesis of bacterial cell walls. Gram-positive bacteria, especially cocci, including penicillinase-pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546
Inventor 李穿江
Owner SICHUAN PHARMA
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