Vonoprazan 20 mg F.C.

T
Composition

mg
Ingredients Reference*** Function
/Tablet
Active Ingredients:
Vonoprazan fumarate equivalent to USP 26.72* Active
Vonoprazan 20 mg
Inactive Ingredients:
Mannitol fine powder USP 89.64** Diluent
Microcrystalline cellulose PH 102 USP 54.64 Diluent
Hydroxypropyl cellulose USP 2.0 Surfactant
Fumaric acid USP 5.0 Stabilizer
Croscarmellose sodium USP 20.0 Disintegrant
Colloidal silicone dioxide USP 1.0 Glidant
Magnesium stearate USP 1.0 Lubricant
Total core Weight 200
Coat ingredients
Hydroxypropyl Methyl cellulose (E5) USP 3.52 Coat forming
Polyethylene glycol (PEG6000) USP 0.70 plasticizer
Talc USP 0.50 Glidant
Titanium dioxide C.I. 77891 USP 0.80 Opacifier
Red iron oxide USP 0.50 Color
Coat weight 6.0 mg
Total Tablet weight 206.0 mg
* Actual amount of Vonoprazan =Theoretical amount of Vonoprazan X 100 X 100

Assay as anhydrous X (100-M.C)

**Actual amount of Mannitol =232.72-Actual amount of Vonoprazan =…………….
*** Referee to the last pharmacopeia.