WENOVO PHARMACEUTICALS

PRODUCTION DEPARTMENT
MASTER FORMULATION
Document No. WNP/PR/MF-094 Version: 000 Date of Issue: Feb-2023 Review Date: Feb-2025

MASTER FORMULA TION

White to slightly
Product: Acetyl cysteine 200mg sachet Shelf life: 02 years
pink color
Standard Batch size: 70000 sachets Pack size: 1×30’s powder

Composition: Each sachet contains:-

Acteyl Cysteine…….………........ 200mg (Manufacturer’s Specifications)

Raw Material
Sr # Ingredients Specifications Quantity Quantity Overage Active / Action
Per tab per batch (%) Inactive
(mg) (Kg)
Mucolytic-
1 Acetyl cysteine In-House 214.132 14.989 5% API fluidifying
action
2 Sorbitol BP 759.208 53.144 ___ Excipient Diluent
___
3 Aspartame BP 26.00 1.820 Excipient Sweetener

4 Lemon Flavor BP 0.66 0.0462 ___ Excipient Flavoring agent

Weight per sachet= 1000mg/sachet Quantity per batch=70.00kg

Assay of Acetyl cysteine= 98.07% (O.D.B)

Note: (Claimed Qty x 100/Assay + overage) = Qty/composition at given Assay

Designation Production Officer QA Manager Production Manager Plant Manager

Name Sadia Habib Shanza Habib Saqib Yaqub Awan Muhammad Imran

Signature
Prepared by Reviewed by Verified by Approved by
Page 1 of 2
 WENOVO PHARMACEUTICALS
PRODUCTION DEPARTMENT
MASTER FORMULATION
Document No. WNP/PR/MF-094 Version: 000 Date of Issue: Feb-2023 Review Date: Feb-2025

MASTER FORMULA TION White to slightly

Product: Acetyl cysteine 200mg sachet Shelf life: 02 years pink color
Standard Batch size: 70000 sachets Pack size: 1×30’s powder

Composition: Each sachet contains:-

Acteyl Cysteine…….………........ 200mg (Manufacturer’s Specifications)

Primary Packaging Material

Sr# Item Qty per pack Qty per batch Overage (%)
(gm) (kg)
01 Printed Megi Paper (116mm) 10.178 26.119 10%

Note: Formula for calculating Qty per batch = Qty per pack x no. of packs + Overage
1000

Secondary Packaging Material

Sr # Item Quantity Per Pack Quantity per batch Overage

01 Unit Cartons 1.00 2380 2%

0 Master Carton 24 1%
No. of Packs per Master Carton = 100 packs

Note: Formula for calculating Qty per batch = Qty per pack x No. of packs+ Overage

Remarks: Master Formulation Record will be revised if there is change in Formula, Primary Packaging
Material & any other critical change.

Designation Production Officer QA Manager Production Manager Plant Manager

Name Sadia Habib Shanza Habib Saqib Yaqub Awan Muhammad Imran

Signature
Prepared by Reviewed by Verified by Approved by
Page 2 of 2