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Lidocaine impurity, application of lidocaine impurity in detection method and detection method

A lidocaine and detection method technology, applied in the directions of organic chemistry methods, measuring devices, instruments, etc., can solve problems such as affecting the public's drug safety, the sustainable and healthy development of the pharmaceutical industry, adverse drug product quality assurance, and unfavorable discovery of unknown impurities, etc. To achieve the effect of strong specificity, easy operation and control, and guarantee of drug safety

Pending Publication Date: 2022-06-21
SHANGHAI VIWIT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] At present, in the preparation or production of lidocaine, the related research on impurity control is still very shallow, and it is still in the initial stage of indirectly realizing the impurity control in drugs by controlling the purity of API, for example: CN 102070483 A, CN105294477 A, CN 110590590 A, etc. These are still unable to realize the qualitative and / or quantitative detection of impurities in the lidocaine production process, which is not conducive to the discovery of new unknown impurities in its preparation or production process and to find ways to control them, nor is it conducive to the product quality of the drug Guarantee, which in turn will affect the safety of public medication and the sustainable and healthy development of my country's pharmaceutical industry

Method used

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  • Lidocaine impurity, application of lidocaine impurity in detection method and detection method
  • Lidocaine impurity, application of lidocaine impurity in detection method and detection method
  • Lidocaine impurity, application of lidocaine impurity in detection method and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] 1. Preparation of chloroacetyl-2,6-dimethylaniline

[0103]

[0104] Include the following steps:

[0105] A, inert gas (nitrogen) protection, add 16kg (about 132mol) 2,6-dimethylaniline, 11.09kg (about 132mol) sodium bicarbonate and 96L methylene dichloride in the reactor, stir, add 16.4kg ( About 145mol) chloroacetyl chloride (control the temperature in the kettle -5~15℃), stir the reaction at -5~15℃ for 1h, GC (gas chromatography) or TLC (thin layer chromatography) monitoring reaction is basically complete (2,6- The residual amount of dimethylaniline≤2wt%) ends after;

[0106] b. Add 16kg of purified water to the kettle, stir evenly, then distill under reduced pressure (vacuum degree≤-0.09MPa, temperature 40~45 ℃) to basically no fraction, then add 176kg of purified water to the kettle, at 15~35 After stirring at °C for 2 h, centrifugation, and drying by air blowing (50-60 °C), chloroacetyl-2,6-dimethylaniline was obtained as a white powdery solid with a yield o...

Embodiment 2 and 3

[0167] The same content as Example 1 will not be repeated, the difference is that in the step a of preparing chloroacetyl-2,6-dimethylaniline, the consumption of chloroacetyl chloride is changed to 132mol and 158.4mol respectively, namely: 1 equivalent , 1.2 equivalents, and finally obtain chloroacetyl-2,6-dimethylaniline, white powdery solid, the yield is all ≥90% (calculated as 2,6-dimethylaniline), the HPLC purity is all ≥98%, impurity The content of A is in the range of 0.6% to 1.5%.

Embodiment 4～6

[0169] The same content as Example 1 is not repeated, the difference is that in the step a of preparing chloroacetyl-2,6-dimethylaniline, the consumption of sodium bicarbonate is changed to 106mol, 158.4mol, 198mol respectively, namely: 0.8 equivalents, 1.2 equivalents, and 1.5 equivalents, and finally chloroacetyl-2,6-dimethylaniline was obtained as a white powdery solid, the yields were all ≥95% (calculated as 2,6-dimethylaniline), and the HPLC purity was uniform. ≥98%, the content of impurity A is in the range of 0.6% to 1.5%.

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Abstract

The invention discloses lidocaine impurities, application of the lidocaine impurities in a detection method and the detection method. The lidocaine impurity compound disclosed by the invention is a compound as shown in a formula I which is described in the specification. The lidocaine impurity compound provides a basis for quality and safety evaluation of lidocaine or intermediates, salts, crystal forms and solvates of lidocaine, and is of great significance in improving the quality of lidocaine or intermediates, salts, crystal forms and solvates of lidocaine.

Description

technical field [0001] The invention belongs to the field of drug (and / or its intermediate) detection and impurity control, and specifically relates to lidocaine impurities and its application in a detection method and the detection method. Background technique [0002] Medicines, including APIs and preparations, are a special commodity for preventing, treating and / or diagnosing diseases, and their quality is related to the health and safety of the public. Therefore, ensuring its safety, effectiveness and controllable quality is the top priority throughout the entire process of research and development, production, storage, and clinical application. Whether various impurities in a drug can be accurately identified and controlled is directly related to the quality controllability and safety of the drug. It is a key link in its quality assurance and an important part of drug consistency evaluation. index. [0003] Impurities refer to other substances that appear in the drug ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C233/07C07C271/64G01N30/02G01N30/32G01N30/34G01N30/60
CPCC07C233/07C07C271/64G01N30/02G01N30/32G01N30/34G01N30/6052G01N2030/047G01N2030/324C07B2200/13
Inventor 魏彦君杜文峰刘金飞宋于强刘希望徐青景邢艳平黄辉
Owner SHANGHAI VIWIT PHARMA CO LTD
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