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
ItemsSpecificationsResults
DescriptionWhite or off-white powderConforms
Identificationa)IR Spectrum :Must ComplyConforms
b)HPLC: Retention Time Must ComplyConforms
Optical Rotation-0.10º— +0.10º+0.00º
Clarity of Solutiona)1% Solution in water: ClearConforms
b)1% Solution in methanol: ClearConforms

 

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
pHpH of 1% aqueous solution:6.2-7.06.59
Heavy MetalsNot More Than 10ppm<10ppm
Residue on ignitionNot More Than 0.1%0.01%

 

WaterNot More Than 0.5%0.16%
Assaya)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 1000ppm22ppm
Conclusion: The product meets the above specifications.