Each tablet contains delayed-release Naproxen Sodium USP equivalent to Naproxen 500 mg and immediate-release Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
Sl. | Tests Parameters | Specification |
1 | Appearance | 19.0 X 8.5 mm oblong, coffee, standard convex tablet |
2 | Identification | Must be positive for Naproxen Sodium & Esomeprazole Magnesium Trihydrate. |
3 | Thickness | 6.10 – 6.25 mm |
4 | Loss on Drying | 3.0 – 4.0 % w/w |
5 | Recommended Weight/Tablet | 858.61 – 948.99 mg |
6 | Dissolution (For Esomeprazole) | Not less than 80% of the label claim |
7 | Dissolution (For Naproxen) | Not more than 15% & not less than 85% of the label claim in 0.1M Hydrochloric Acid & 0.2M Phosphate Buffer of pH 6.8 respectively |
8 | Weight Variation | ± 5 % of average weight |
9 | Assay | Naproxen 450.0 – 550.0 mg & Esomeprazole 18.0 – 22.0 mg per tablet |