Specification for Ivermectin 12mg Tablets  USP

Specification for Ivermectin 12mg Tablets USP

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:
Shelf life 24 months
Storage direction: Store at a temperature below 30°.
Reference : As per U.S.P.