| Sr. No. |
TEST |
OBSERVATION |
SPECIFICATION |
| 1 |
Description |
White to off-white colored powder |
A white to of-white powder. |
| 2 |
Solubility |
Freely soluble in methanol. |
Freely soluble in methanol. |
| 3 |
Identifications A By I.R.
|
A. Complies |
A. The IR spectrum of the substance being examined must be concordant with the IR spectrum obtained from Desloratidine working standard. |
| 4 |
Water content by KF |
0.38% |
NMT 1.0% (w/w) |
| 5 |
Melting range |
154.5 °C to 155 °C |
Melting range between 152°C & 159°C. |
| 6 |
Heavy metals |
Complies |
NMT 20 ppm. |
| 7 |
Sulphated Ash |
0.055% |
NMT 0.10% (w/w) |
| 8 |
Related Substances By HPLC
Any other individual impurity:
Total impurities:
|
0.058%0.072%
|
Any other individual impurity : NMT 0.10%
Total impurities: NMT 0.30%
|
| 9 |
Assay by Titremetry (On anhydrous basis)
|
99.66 % |
NLT 99.0% and NMT101.0% w/w |
