M/S. BIMAL PHARMA PVT. LTD .
MUMBAI (INDIA)
1.
FINESHED PRODUCT
INFORMATIONS
QUALITY CONTROL AND ASSURANCE
PRODUCT : IBUPROFEN
MSDS no. BPPL 017
SPECIFICATION NO. FP-017
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 order.
7.
THERAPEUTIC USE
:
Anti-Inflammatory & Analgesic
M/S. BIMAL PHARMA PVT. LTD .
MUMBAI (INDIA)
FINESHED PRODUCT
PHARMACOPOEIAL SPECIFICATIONS
QUALITY CONTROL AND ASSURANCE
PRODUCT : IBUPROFEN
MSDS no. BPPL 017
SPECIFICATION NO. FP-017
1.
DESCRIPTION
:
White Crystalline Powder,
Free flowing, with characteristic odor.
2.
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.
:
3.
IDENTIFICATION
:
i) UV Spectrophotometry:
:
:
ii)
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
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.
4.
MELTING POINT
:
75C – 78C
5.
RELATED SUBSTANCES
BY HPLC
:
Impurity B
In Chromatograph, peak
corresponding to 2- (4- Butyl Phenyl)
Propionic Acid should not be greater
than 0.3%.
M/S. BIMAL PHARMA PVT. LTD .
MUMBAI (INDIA)
FINESHED PRODUCT
PHARMACOPOEIAL SPECIFICATIONS
QUALITY CONTROL AND ASSURANCE
PRODUCT : IBUPROFEN
MSDS no. BPPL 017
SPECIFICATION NO. FP-017
:
Total Impurities
The sum of the Areas of any such
peaks is not greater than 0.7%
6.
IMPUTIRY F
:
BY GAS CHROMATOGRAPHY
Maximum 0.1%
7.
CLARITY & COLOUR OF
:
SOULTION
(APPEARANCE OF SOLUTION)
10% Solution in Methanol is
Clear and Colorless
8.
OPTICAL ROTATION
:
-0.05 to +0.05
9.
HEAVY METALS
:
Not more than 10 ppm.
10.
LOSS ON DRYING
:
Not more than 0.5%
11.
SULPHATED ASH
:
Not more than 0.1%
12.
ASSAY (ODB)
:
98.5% to 101%