master formula record analgin injection

NAME OF PRODUCT : ANALGIN INJECTION 30 ML VIAL

Colour : Clear, colourless solution.

COMPOSITION : Each ml Contains:

Analgin 500 mg

Chlorbutol 0.4 % w/v

BATCH SIZE : 100 Litres

SELF LIFE : 2 Years

PACKAGING : 30 ml Amber vial

MANUFACTURING FORMULA

Sr. No.	Raw Materials	Qty Per ml	Overages	Total qty per ml	Quantity per batch
01.	Analgin	500mg	–	500mg	50.0kg
02.	Sodium Thiosulphate	1.0mg	–	1.0mg	100.0gm
03.	Chlorbutol	4.0mg	–	4.0mg	400.0gm
04.	Benzyl Alcohal	1.5 % v/v	–	1.5% v/v	1.500 litre
05.	Acetic Acid Glacial	0.1 %	–	0.1 %	100 ml

CALCULATION : Analgin I.P. 500 mg

– For each ml

– 100
_____________ x 500 mg x 100 Litres
-(Assay – Water)

-( Assay according to Quality Control Report )

BULK MANUFACTURING :
1. Clean all the equipment /containers required for bulk manufacturing with (teepol/liquid soap) rinse it with tape water and D.M. Water.
2. In the bulk manufacturing area rinsed twice all the above mentioned items with fresh distilled water.
3. Collect 45 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.
4. Then add sodium thiosulphate , chlorbutol ,benzyl alcohol and then add analgin with continuous stirring.
5. Finally check and adjust the pH between 5.5 to 6.5 with Glacial Acetic Acid.
6. Make up the volume upto 100 litres.

Note – should be kept 5.9 as pH on standings.

Contents : 30.5 ml

pH : 5.5 to 6.5

Assay : Analgin I.P. 500mg/ml

Limit 90. % to 110.0%

Theoretical yield at different stages :

Scheduled fill : yield permissible limit

Filling rejection 1.5 % : 0 to 2.5%

Optical checking rejection 6% : 0 to 8.0 %

Total rejection :

Normal yield :

After optical inspection vials are kept on labeling machine .