|
TEST
|
RESULTS
|
REQUIREMENTS
|
|
Characteristics
|
Passes
|
White to off white crystalline powder.
|
|
|
Passes
|
Practically insoluble in water soluble
in alcohol & in acetone.
|
|
Identification
|
Confirmed
|
By IR spectroscopy.
|
|
X-ray Diffraction
|
Passes
|
As per USP
|
|
Acidity
|
Passes
|
Max.1.0ml
|
|
Alkalinity
|
Passes
|
Max.1.0ml
|
|
Loss on Drying
|
0.12%
|
Max. 0.5%
|
|
Residue on ignition
|
0.058%
|
Max.0.1%
|
|
Chloride
|
Passes
|
As per USP
|
|
Chromatography purity
|
Passes
|
Max. 0.2% for single impurity
|
|
|
|
Max. 0.5% for total impurity
|
|
Organic Volatile Impurities
|
Passes
|
As per USP
|
|
Assay
|
99.7%
|
bet. 98.0% to 102.0%
(calculated on dry basis)
|
|
Water
|
Not more than 2.0%
|
0.8%
|
|
Residue on ignition
|
Not more than 3.0%
|
0.16%
|
|
Heavy Metals
|
Not more than 0.002%
|
<0.002%
|
|
Assay
(On anhydrous basis)
|
Between 960 & 1040 mcg/mg
C38H69NO13 per mg
|
1026 mcg/mg
|
