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|
|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 :
At the start of the batch the printing of the labels should be checked and signed by competent person.
Periodic check has to be done so that the labeled ampoules have a good aesthetic appearance.