SURGE Laboratories Private Limited

Production Department

Title:
Product Master Formula
PMFSubject:
Product Manufacturing Formula (PMF)
Product:
Levo-floxacin 500mg/100ml IV Infusion
Revision No.: 0
Date: 01-05-2009
Drug
Product Code
Batch #
Batch Size
Pack Size
Page #
Registrat
420 Litres
ion #
LVI
LVI
4000 Vials
1s X 100ml
Page 1 of 1
044763
Shelf Life
Mfg. Date
Exp. Date
Expected Batch
Actual Batch Yield
Yield
2 Years
95 105%

1.0

Prepared By

Reviewed By

Approved By

Authorized By

Manager P & D

Manager Production

Manager QA

G.M Plant & Production

Active Ingredients

Code #

Ingredients
*Ciprofloxacin Powder
(5% overage inclusive)

2.0

Qty. / Vial

Qty. / Batch

Units
Kg / L

Reference

0.210 gm

0.857

Kg

USP30-NF25

*Ciprofloxacin Powder is calculated at 100 % potency. Adjust the quantity of Active Ingredient to 100
% if potency varies.
In -Active Ingredients

Code #

Qty. / Vial

Qty. / Batch

Units
Kg / L

Reference

Dextrose Anhydrous

5.000 gm

20.400

Kg

USP30-NF25

Lactic Acid (90%)

0.110 ml

0.448

USP30-NF25

USP30-NF25

USP

Ingredients

Hydrochloric Acid (10% Solution) for

PH adjustment at 4.05
Water for Injection (QS)

QS
100 ml

408.000