|
Sr.No.
|
Test
|
Specification
|
Result
|
|
1
|
Description
|
Off white to light yellow powder
|
A light yellow powder.
|
|
2
|
Solubility
|
soluble in methanol
|
Complies
|
|
3
|
Identification
3.1 a)By IR
b)
|
IR Spectrum of the sample should match with that of standard spectrum.
The Retention time of major peak of sample should correspond to that of standard by HPLC
|
Complies
Complies
|
|
3.2 Test for Sodium
|
Shall respond to test for sodium
|
Complies
|
|
4
|
Water Content by KF (%w/w)
|
Not more than 2.0
|
1.1
|
|
5
|
Heavy Metals (ppm)
|
Not more than 2.0
|
Less than 20
|
|
6
|
Related substances by HPLC(%)
6.1 Any individual impurity
6.2 Total Impurities
|
Not more than 0.5
Not more than 1.5
|
0.19
0.58
|
|
7
|
Assay by HPLC (%w/w)
(on anhydrous basis)
|
98.8 to 102.0
|
100.0
|
|
8
|
Residual solvents/OVi by GC-HS (ppm)
a. Methanol
b. Acetone
c. Acetonitrile
d. Dichloromethane
e. N- heptane
f. Ethanol
g. Toluene
h. tetrahydrofuran
|
Not more than 3000
Not more than 5000
Not more than 410
Not more than 600
Not more than 5000
Not more than 5000
Not more than 890
Not more than 720
|
7
Not detected
Not detected
Not detected
1488
Not detected
588
142
|
|
9
|
Acetic acid content by GC
(ppm)
|
Not more than 5000
|
1416
|