Delafloxacin impurities I and II and product refining method

A technology of delafloxacin and a refining method, which is applied in the field of impurities I and II of delafloxacin and product refining, can solve the problems of difficulty in detecting impurities, and achieve the effects of reducing energy consumption, mild conditions and improving product quality.
CN111718331AInactive Publication Date: 2020-09-29NANJING HAIRUN PHARM CO LTD +1
8 Cites 1 Cited by

Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
NANJING HAIRUN PHARM CO LTD
Publication Date
2020-09-29
Estimated Expiration
Not applicable · inactive patent

Smart Images

  • Figure 1
    Figure 1
  • Figure 2
    Figure 2
  • Figure 3
    Figure 3
Patent Text Reader

Abstract

The invention belongs to the field of medicine impurities, and particularly relates to delafloxacin impurities I and II and a product refining method. A proper analysis method is selected through optimization to detect related stubborn impurities of a product. The specific structure of related impurities is separated, detected and confirmed. Finally, synthesis and process routes are optimized, impurities are controlled within a safe range, a basis is provided for product process amplification, stability, quality, pharmacology and toxicology and clinical research, and the method has important significance in reducing the safety risk of drug impurities.
Need to check novelty before this filing date? Find Prior Art

Description

technical field

[0001] The invention belongs to the field of pharmaceutical impurities, in particular to impurities I and II of delafloxacin and a product refining method. Background technique

[0002] Delafloxacin (Delafloxacin) is a new type of fluoroquinolone antibiotics for the treatment of acute bacterial skin and skin tissue infections caused by special G- and G+ bacteria, including MRSA and Pseudomonas aeruginosa; The chemical structure of the amine salt is shown in the following formula:

[0003]

[0004] Delafloxacin was first developed by Wakunaga Pharmaceuticals. In 2006, Rib-X (now Melinta) obtained the global exclusive authorization of the drug, and it was approved by the US Food and Drug Administration (FDA) on June 19, 2017. , the product name is At present, the drug has not been approved for marketing in China.

[0005] Impurity control is one of the core contents of drug quality control. The adverse reactions of drugs in clinical use are often related...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More