Wednesday , December 11 2024

Naproxen 500 mg + Esomeprazole 20 mg Tablet | Specification

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 ParametersSpecification
1Appearance19.0 X 8.5 mm oblong, coffee, standard convex tablet
2IdentificationMust be positive for Naproxen Sodium & Esomeprazole Magnesium Trihydrate.
3Thickness6.10 – 6.25 mm
4Loss on Drying3.0 – 4.0 % w/w
5Recommended Weight/Tablet858.61 – 948.99 mg
6Dissolution (For Esomeprazole)Not less than 80% of the label claim
7Dissolution (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
8Weight Variation± 5 % of average weight
9AssayNaproxen  450.0 – 550.0 mg & Esomeprazole 18.0 – 22.0 mg per tablet

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