PRODUCT Active Ingredient Content %ODV Uniformity of Dosage Units %ODV Dissolution Test Average Dissolved % in 20 min Reference H011579 98.56 ± 0.02 95.12 96.10 Trial 2R3789A 104.23 ± 0.05 104.13 96.40 Trial 2E1775 103.16 ± 0.02 102.94 97.60 Trial 2J2389A 103.85 ± 0.06 104.50 96.40 Specification %ODV: 95-105% %ODV: 95-105% Average Dissolved % in 20 min should not be under 80% of the declared amount Result Complies Complies Complies %ODV: Percentage over declared value

Table 1: Results obtained from the active ingredient content controls; uniformity of dosage units and dissolution test for the reference drug batch and the test drug batches.

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