|
|
TEST |
SPECIFICATION |
|
01. |
Description
|
An orange colour
crystalline powder. |
| 02. |
Solubility |
Soluble in water |
| 03 |
Identification |
a) IR: The
Infra Red absorption spectrum of the finely ground sample in KBr
dispersion compressed into a disc should exhibit maxima only at the same
wavelengths as that of a similar preparation of Balasalazide Disodium
Dihydrate working standard.
|
| 04. |
Water
content by KF |
Should be
between 4.0% and 8.5% w/w |
| 05. |
Melting Range |
Should
not be less than 350
oC |
| 06. |
Heavy Metals |
Less than 0.002% w/w |
| 07. |
Sulphated
ash |
Should not be
more than 0.1% |
| 08. |
Related
substances
By HPLC |
Single
maximum impurity NMT : 1.0%.
Total impurities NMT : 2.0% |
| 09. |
Assay (on anhydrous basis)
by Titration |
Should be between 98.0% and102.0% w/w.
|
