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
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NLT 80% (Q) of the labeled amount of C48H74O14 (H2B1a) plus C47H72O14 (H2B1b) is dissolved in 45 min.
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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: | |||||
Shelf life | 24 months | ||||
Storage direction: Store at a temperature below 30°. | |||||
Reference : As per U.S.P. | |||||