master formula record chlorpheniramine maleate injection

NAME OF PRODUCT : CHLORPHENIRAMINE MALEATE INJECTION

COMPOSITION : Each ml Contains:

Chlorpheniramine Maleate I.P. 10 mg

Water for injection I.P. q.s.

BATCH SIZE : 100 Litres

SELF LIFE : 2 Years

PACKAGING : 1 ml Amber ampoule

MANUFACTURING FORMULA :

Sr. No.	Raw Materials	Qty Per ml	Overages	Total qty per ml	Quantity per batch
01.	Chlorpheniramine maleate I.P.	10.0mg	2 %	10.2mg	1.020 kg
02.	Sodium Metabisulphite I.P.	0.50mg	–	0.50mg	50.0 gm
03.	Disodium EDTA I.P.	0.20mg	–	0.20mg	20.0gm
04.	Benzyl alcohol I.P.	1.5%	–	1.5%	1.50 liter
05.	Maleic Acid I.P.	0.16 mg	–	0.16 mg	16.0gm
06.	Water for injection I.P.	Q.S.	–	Q.S.	Q.S.

CALCULATION : Chlorpheniramine maleate I.P.10.0mg

— For each ml

— 100

— _____________ x10 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 60 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.
4. Then add disodium E.D.T.A.and then add Benzyl alcohol with continuous sterring,solution A .
5.Collect 2 litres fresh disttiled water in flosk then add sodium metabisulphite ,solution B.
6.Collect solution A and B then add Chlor pheniramine maleate with continuous sterring.
7. Finaly check pH 4.75 and adjust the pH between 4.0 to 5.2 with maleic Acid.
8. Make up the volume upto 100 litres.

Product Name : Chlopheniramine Maleate injection

Self life : 2Years

Colour : Clear, colourless solution.

Contents : 1.10 ml

pH : 4.0 to 5.2

Assay : Chlorpheniramine Maleate I.P. 10mg/ml

Limit 90.0 % to 110.0%

Theoretical yield at different stages :

Scheduled fill : 90909 yield permissible limit

Filling rejection 1.5 % : 1363 89546 0 to 2.5%

Optical checking rejection 6% : 5454 84092 0 to 8.0 %

Total rejection : 6817

Normal yield : 84092