| SR. NO. |
TESTS |
SPECIFICATIONS |
RESULT
|
| 1. |
DESCRIPTION |
White or almost white powder. |
White to almost white powder. |
| 2. |
SOLUBILITY |
Practically insoluble in water, sparingly soluble in methylene chloride, slightly soluble in alcohol. |
Complies. |
| 3. |
IDENTIFICATION |
- I.R.
- The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (b)..
|
Complies. Complies.
|
| 4. |
SPECIFIC OPTICAL ROTATION |
+32° to +36° |
+34.5° |
| 5. |
RELATED SUBSTANCES
- Impurity A
- Impurity B
- Impurity C
- Impurity D
- Impurity E
- Impurity F
- Impurity H
- Impurity I
- Total Impurity
|
Not more than 0.2%Not more than 0.2%
Not more than 0.2%
Not more than 0.3%
Not more than 0.2%
Not more than 0.3%
Not more than 0.2%
Not more than 0.2%
Not more than 1.2%
|
0.101%Nil
0.12%
0.04%
0.16%
0.24%
0.14%
0.08%
0.881%
|
| 6. |
SULPHATED ASH |
NMT 0.1% |
0.04% |
| 7. |
LOD |
NMT 2.0% |
0.32% |
| 8. |
ASSAY |
NLT 97.0% & NMT 100.0% |
99.49% |
