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
CN114644571APending Publication Date: 2022-06-21SHANGHAI VIWIT PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SHANGHAI VIWIT PHARMA CO LTD
Publication Date
2022-06-21

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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.
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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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