|
Sr.no
|
Tests
|
OBSERVATION
|
I.P /U.S.P Limits
|
|
1
|
Description
|
A white crystalline odourless powder.
It melts at 140oC with decomposition
|
White to Pale yellow Crystalline Odourless
powder. It melts at 140oC with
decomposition
|
|
2
|
Solubility
|
Complies
|
Very soluble in water & moderately
in alcohol
|
|
3
|
Identification
|
Complies
|
As per U.S.P
|
|
4
|
PH
|
5.88
|
4.5 to 6.0
|
|
5
|
Loss on Drying
|
0.43%
|
NMT 0.75% at 60oC in Vacuo
for 3 Hrs.
|
|
6
|
Residue on Ignition / Sulphated Ash
|
0.07%
|
0.1%
|
|
7
|
Chromalography Purity / Related Sub.
|
Complies
|
As per U.S.P
|
|
8
|
Organic Volatile Imp
|
Complies
|
As per U.S.P
|
|
9
|
Assay by HPLC
|
99.11%
|
NLT 97.5% NMT 102.0% of Cl3 H21 N4 O3
S.HCI
|
|
10
|
C.O.S
|
0.087 A
|
|
|
11
|
Back Density
|
0.55 gm / cc
|
|
