|
S.No.
|
Test
|
RESULT
|
SPECIFICATION
|
|
01.
|
Characters
|
A white powder, freely soluble in water, practically insoluble in acetone and in methylene chloride.
|
A white or almost white powder, freely soluble in water, practically insoluble in acetone and in methylene chloride
|
|
02.
|
Identification
A.UV absorption spectrum
B.IR absorption spectrum
C.TLC
D.Reaction of Chlorides
|
Similar to working standard
Similar to working standard
Similar to working standard
Positive
|
To match with working standard
To match with working standard
To match with working standard
To meet the test
|
|
03.
|
Appearance of solution
|
Solution S is clear and less intensely coloured than reference solution BY7
|
Solution S should be clear and not more intensely coloured than reference solution BY7
|
|
04.
|
pH(5%solution in water)
|
1.6
|
Between 1.2 to 1.8
|
|
05.
|
Related substances by HPLC
a. Maximum unknown
individual impurity
b. Total impurities.
|
0.35%
0.82%
|
Not more than 0.5%
Not more than 1.0%
|
|
06.
|
Heavy metals
|
Less than 10ppm
|
Not more than 10ppm
|
|
07.
|
Loss on drying
|
0.3%w/w
|
Not more than 0.5%w/w
|
|
08.
|
Sulphated ash
|
0.07%w/w
|
Not more than 0.2%w/w
|
|
09.
|
Assay (on dried basis)
|
99.6%w/w
|
Not less than 99.0%w/w ad
Not more than 100.5%w/w
|
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