("New Drug Conversion Standards", Vol. 48, WS 1 -(X-513)-2003Z).

Product name: Lomefloxacin Hydrochloride

Chemical Structure:

Molecular Formula: C₁₇H₁₉F₂N₃O₃

Molecular Weight: 387. 81

This product is (±)1-ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline carboxylic acid hydrochloride. Calculated as a dry product, the content of lomefloxacin (C₁₇H₁₉F₂N₃O₃) shall not be less than 89.2%.

 

[Property] is white or off-white crystalline powder, almost odorless, bitter taste

 

(1) IR The infrared absorption pattern of this product should be consistent with the control pattern

(2) The retention time of the main peak of the HPLC test sample should be consistent with the retention time of the main peak of the control substance

(3) The aqueous solution of this product should show the identification of chloride

 

The clarity and color of the solution should be in accordance with the regulations

The relevant substance shall not exceed 0.5% of a single impurity

The total impurities shall not exceed 1.0%.

Loss on drying              Must not exceed 0.5%                         

Residue on ignition              Must not exceed 0.1%                          

Heavy metals shall not exceed 20 parts per million

[Content determination] According to the dry product, the content of lomefloxacin (C17H19F2N3O3) shall not be less than 89.2%.