BIMAL PHARMA PVT. LTD.   www.bimalpha.com

PRODUCT : IBUPROFEN  
1 NOMENCLATURE 
(2 RS) – 2- [4- (2-Methyl Propyl)   Phenyl] Propionic Acid.
2-(4-Iso Butyl Phenyl) Propionic Acid.
P- Iso Butyl Hydratropic Acid.
2 CAS NO.  15687-27-1
3 EMPIRICAL FORMULA  C13H18O2
4 MOL. WT. 206.30
5 STRUCTURAL FORMULA            
6 DESCRIPTION  White Crystalline Powder;  

Free flowing, with characteristic odor.
7 SOLUBILITY
Practically insoluble in Water Freely soluble in Acetone, in Methanol and in Methylene Chloride.
It dissolves in Dilute solutions of Alkali Hydroxides and Carbonates.
8 IDENTIFICATION 

 

 

 i)      UV Spectrophotometry

        

The Ratio of the Absorbance measured at the minimum at 264 nm to that   

measured at the shoulder at 258 nm is 1.20 to 1.30

 

The ratio of the Absorbance measured at  the maximum at 272 nm to that 

measured at the shoulder at 258 nm is  1.00 to 1.10.

 

ii)       IR Spectrophotometry

 

IR absorbance spectrum with the Substance  should be concordant with 

Reference  Standard  spectrum.

 

 

 iii)     By TLC

 

The principal spot in the Chromatogram obtained  with the Test Solution is 

similar in Position, Colour and Size to the principal spot in the chromatogram 

obtained with the Reference  Solution.

 
9 MELTING POINT 75°C – 78°C
10

RELATED SUBSTANCES        

BY HPLC         

 

Impurity B

        In Chromatograph, peak corresponding to             

        2- (4- Butyl Phenyl) Propionic Acid should not       

        be greater than 0.3%.

 

Total Impurities

        The sum of the Areas of any such peaks is not    

        greater than 0.7%.

 

 

 

 
11 IMPURITY BY GAS CHROMATOGRAPHY Maximum 0.1%
12

CLARITY & COLOR OF

SOLUTION

(APPEARANCE OF SOLUTION)

 		10% Solution in Methanol is Clear and Colorless.
13 OPTICAL ROTATION -0.05° to  +0.05°
14 HEAVY METALS

Not more than 10 ppm.
15 LOSS ON DRYING Not more than 0.5%
16 SULPHATED ASH Not more than 0.1%
17 ASSAY (ODB) 98.5%  to 101%
18 THERAPEUTIC USE Anti-Inflammatory & Analgesic.