|
Sr.No
|
Test |
Observations |
Specifications |
1
|
Description |
Almost white crystalline powder |
A white or almost white crystalline powder. |
2
|
Solubility |
Freely soluble in water, practically insoluble in acetone, and in methylene chloride. |
Freely soluble in water, practically insoluble in acetone, and in methylene chloride. |
| 3 |
Appearance of Solution
|
5%solution is clear and not more intensely colored than reference solution BY7 |
5%solution is clear and not more intensely colored than reference solution BY7 . |
4
|
Identifications |
Test A, C & D Complies. |
Test B & D or A, C and D complies. (As per E.P. ) |
5
|
PH |
1.5 |
1.2 to 1.8 |
6
|
Loss On Drying |
0.4% |
Not more than 0.5% w/w. |
7
|
Sulphated Ash |
0.1% |
Not more than 0.2% w/w. |
8
|
Heavy Metals |
Complies |
Not more than 10 ppm. |
9
|
Particle size
|
Complies |
NLT 60% <10& rest bet n 10-100 micr Min. 90% < 80 mesh
|
10
|
Residual Solvent Methanol
Ethyl Acetate
Acetone
Methelene chloride
Toluene
|
CompliesComplies
Complies
Complies
Complies
|
Not more than 500 ppm Not more than 100 ppm
Not more than 2000 ppm
Not more than 500 ppm
Not more than 50 ppm
|
11
|
Related Substance ( By HPLC )
|
Complies |
As per E.P. |
| 12 |
Assay ( On Dried Basis )
|
99.9 % |
99.0% to 100.5% w/w as C21 H27O3N2Cl3.
|
