master formula record aminophylline injection

NAME OF PRODUCT : AMINOPHYLLINE INJECTION

COMPOSITION : Each ml Contains:
Aminophylline I.P.25 mg
Water for injection I.P. q.s.
BATCH SIZE :100 Litres

SELF LIFE : 2 Years

PACKAGING : 10 ml White ampoule

MANUFACTURING FORMULA :

Sr. No.	Raw Materials	Qty Per ml	Overages	Total qty per ml	Quantity per batch
01.	Aminophylline	25mg	–	25mg	2.5kg
02.	Ethylenediamine	3.0mg	–	3.0mg	300ml
03.	Water for injection	q.s	–	q.s	Q.S.

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 80 litres boiled water for injection in the tank and start nitrogen flushing 30 minutes.
4. Then add Aminophylline and ethylenediamine with continuous stirring.
5. Finaly check and adjust the pH between 9.0 to 9.6 pH limit 8.8 to 10.0.
6. Make up the volume up to 100 litres.

Product Name : Aminophylline Injection

Self life : 2 Years

Colour : Clear, colourless solution.

Contents : 10.5 ml

pH : 8.8 to 10.0

Assay : Aminophylline I.P. 25mg

Limit 93% to 107%

Theoretical yield at different stages :

After optical inspection ampoules are kept on labeling machine .

PACKING DETAILS :

INPROCESS CONTROLS :

PRINTING :
At the start of the batch the printing of the labels should be checked and signed by competent person.

LABELLING :
Periodic check has to be done so that the labeled ampoules have a good aesthetic appearance.