| S.NO. |
TESTS |
SPECIFICATIONS |
| 1. |
Description |
White round shape, uncoated tablet having one side mid break line and other side plain |
| 2. |
Average weight |
400 mg/tab ± 3% |
| 3. |
Uniformity of weight |
Within ±5 % of the average weight |
| 4. |
Identification |
The retention time of the H2B1a and H2B1b peaks in the chromatogram of the assay preparation correspond to those in the chromatogram of the standard preparation as obtained in assay |
| 5. |
Disintegration Time |
NMT 15 minutes |
| 6. |
Friability |
NMT 1.0% |
| 7. |
Uniformity of content |
The acceptance value of the 10 dosage units is less than or equal to L1(L1=15) |
| 8. |
Hardness |
NLT 3.0 Kg/cm2 |
| 9. |
Limit of 8a-oxo-H2B1a |
NMT 2.0% |
| 10. |
Dissolution
|
NLT 80% (Q) of the labeled amount of C48H74O14 (H2B1a) plus C47H72O14 (H2B1b) is dissolved in 45 min.
|
| 11. |
Assay: |
| Each uncoated tablet contains: |
Limit |
| Claim |
In mg |
In % |
| Ivermectin IP |
12.0mg |
10.8 mg to 13.2 mg |
90% to 110% |
|
Pack size: |
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Shelf life |
24 months |
|
Storage direction: Store at a temperature below 30°. |
|
Reference : As per U.S.P. |
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