Q & Q Formula

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QUALITATIVE & QUANTITATIVE FORMULA

Product name: : Acetaminophen Tablets USP 500 mg

Composition:
Each uncoated tablet contains:
Acetaminophen USP : 500 mg
Excipients : Q.S.

Sr. Raw Material Spec. Label Std. Qty / Function


no. Claim Tab.
(mg)
Mixing
1 * Acetaminophen USP 500.0 mg 500.0 mg Active
2 *Maize Starch BP - 21.0 mg Diluent
3 Colloidal Anhydrous Silica BP - 5.0 mg Glidant
Binding
4 Maize Starch BP - 37.0 mg Binder
5 Povidone K 30 BP - 4.0 mg Binder
6 Purified Water BP - Q.S vehicle
Lubrication
7 Magnesium Stearate BP 6.0 mg Lubricant
8 Purified Talc BP 10.0 mg Glidant
9 Croscarmellose Sodium BP 11.0 mg Disintegrant
10 Colloidal Anhydrous Silica BP 6.0 mg Lubricant
Theoretical Avg. wt. of Tablet 600 mg.

Note: * The quantity of active ingredient will change according to the assay of the ingredient
calculated as ERP system. The above quantity is calculated on 100% assay basis.
* Reduce the quantity of Maize Starch BP to compensate the increase in quantity of active ingredient
due to assay.

Prepared By Checked By Approved By


Name & Tejas savaniya Ravindra Gandhi Ritu Chachra
Designation Production Officer Production Manager Q.A. Manager

Signature

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