Aceclofenac is an orally potent non-steroidal antipyretic analgesic and anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic effects. It is used to relieve rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. The inflammation and pain are also very effective for sprains, strains and other soft tissue injuries, pain and swelling after surgery, and also for pain caused by other diseases such as primary dysmenorrhea and uterine annexitis. The drug is safer and more effective than diclofenac, ketoprofen, indomethacin and the like.
|Appearance||White or off-White crystalline powder，This product is soluble in acetone, soluble in methanol or ethanol, almost insoluble in water.||Conforms|
|Identification||（1）Reacts blue with the corresponding reagent and produces precipitate||Conforms|
|（2）This product has a minimum absorption at the wavelength of 249np||Conforms|
|（3）The red absorption spectrum of this product should be consistent with the control spectrum (spectrum set 889)||Be consistent with the control spectrum|
|Clarity and color of ethanol solution||The solution is dissolved in ethanol, the solution should be clear and colorless, such as color development, compared with the yellow green No. 1 standard colorimetric liquid (General Law 0901 first method), not deeper||Conforms|
|Oxide||The color is not more concentrated (0.01%) than the standard sodium chloride solution 5.0ml.||Conforms|
|Loss on drying||Reduce the weight by no more than 0.5%||0.13%|
|Hot residue||Not more than 0.1%||0.06%|
|Heavy metal||Heavy metals must not exceed 10 parts per million||Conforms|
|Relative substance||Diclofenac in the test solution shall not be entangled in 0.2%||0.12%|
|The area of other single impurity peaks shall not be greater than the area of aceclofenac in the control solution (0.2%)||0.06%|
|The area of other impurity peaks shall not be greater than 2.5 times (0.2%) of the area of aceclofenac in the control solution.||0.21%|
|Content determination||Calculated as dry product, containing C16H13CL2NO4, not less than 9.0%||100.4%|
|Conclusion||This batch is in line with the quality standard of the second edition of the Pharmacopoeia of the 2015 edition of the Chinese Pharmacopoeia.|
This product is mainly used for the treatment of symptoms of pain and inflammation caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.