Ibuprofen

CAS number:15687-27-1;58560-75-1

Molecular formula:C13H18O2

molecular weight:206.2734

Chemical structure:

Product Name: Ibuprofen
Shelf Life: 4 years
Items Specifications Results
Description White or off-white powder Conforms
Identification a)IR Spectrum :Must Comply Conforms
b)HPLC: Retention Time Must Comply Conforms
Optical Rotation -0.10o— +0.10o +0.00o
Clarity of Solution a)1% Solution in water: Clear Conforms
b)1% Solution in methanol: Clear Conforms

 

Ibuprofen Related  Substances(by HPLC) a) 2-(4-butylphenyl) propionic acid: Not detected
Not More Than 0.1%(area%)
b) Any other individual Impurity: 0.04%
Not More Than 0.1%(area%)
c)Total Impurity: 0.07%
Not More Than 0.3%(area%)
Lysine Related Substances(by TLC) Any maximum impurity: Not more than0.1% Conforms
pH pH of 1% aqueous solution:6.2-7.0 6.59
Heavy Metals Not More Than 10ppm <10ppm
Residue on ignition Not More Than 0.1% 0.01%

 

Water Not More Than 0.5% 0.16%
Assay a)Lysine content (by titration): 100%
98.5-101.5%
b) Ibuprofen content (by HPLC): 100.3%
98.5-101.5%
Residual Solvents(by GC) Ethanol: Not More Than 1000ppm 22ppm
Conclusion: The product meets the above specifications.