FLUOROURACIL INJECTION

FLUOROURACIL INJECTION:
Batch Size :
Presentation :
It is available in 50 mg / ml in 10 ml Single use vial.
It is Colourless to faint Yellow aqueous sterile solution.
Each 10 ml provides 500 mg Fluorouracil – pH is 8.6 – 9.4
On storage the preparation may get slightly coloured but the potency is maintained.

Sr. No.	Ingredient	Quantity
1	5 – Fluorouracil	500 gms
2	Sodium Hydroxide Dilute sufficient Quantity
3	Water for Injection to make 10Lts

Manufacturing Procedure :

1. Take 3/4^th quantity of Water for Injection in a sterile SS vessel of suitable capacity.
2. Add quantity of dilute sodium hydroxide solution to raise pH to 9.00
3. Add Fluorouracil and stir to dissolve.
4. Make up the final volume
5. Sterilize by filtration through 0.22 micron membrane filter.
6. Fill vials aseptically.

Please Note :
Fluorouracil is insoluble in Water
However, it dissolves completely in presence of alkali such as sodium hydroxide.
The product is thermolabite. Store in cool dark place. Avoid autoclaving.