master formula record calcium gluconate injection
NAME OF PRODUCT : CALCIUM GLUCONATE INJECTION
COMPOSITION : Each ml Contains:
Calcium Gluconate I.P. 10%
Water for injection I.P. q.s.
BATCH SIZE : 100 Litres
SELF LIFE : 3 Years
PACKAGING : 10 ml White Ampoule
MANUFACTURING FORMULA :
|Quantity per batch|
|02.||Calcium d sacchrate||495.0mg||–||495.0mg||495.0gm|
|03.||Sodium hydroxide||_||–||_||As per pH|
|04.||Water for injection||Q.S.||–||Q.S.||Q.S.|
CALCULATION : Calcium gluconate 9.30mg
For each ml
— _____________ x 9.3 mg x 100 Litres
— (Assay – Water)
— ( Assay according to Quality Control Report )
BULK MANUFACTURING :
- Clean all the equipment /containers required for bulk manufacturing with (teepol/liquid soap) rinse it with tape water and D.M. Water.
- In the bulk manufacturing area rinsed twice all the above mentioned items with fresh distilled water.
- Collect 80 litres fresh distilled water in the tank and start boiledand heat.
- Then add Calcium gluconate and calcium d-saccharate with continuous sterring.Boil the solution at least for 3 hours at low heat . Make-up the volume up to the mark with water for injection.
- Finaly checkpH 8.2 and adjust the pH between 6.0 to 8.2 with sodium hydroxide.
- Make up the volume upto 100 litres.
Note – should be kept 8.2 as pH lower on standings.
Product Name : Calcium Gluconate injection
Self life : 3 Years
Colour : Clear, colourless solution.
Contents : 10.50 ml
pH : 6.0 to 8.2
Assay : Calcium gluconate 10%/ml
Limit 8.5 % to 9.4 5% of calcium.
Theoretical yield at different stages :
Scheduled fill : 9523 yield permissible limit
Filling rejection 1.5 % : 143 9380 0 to 2.5%
Optical checking rejection 6% : 571 8809 0 to 8.0 %
Total rejection : 714
Normal yield : 8809
After optical inspection ampoules are kept on labeling machine .
PACKING DETAILS : Box of 50 x 10 ml
Outer of 20 x 50 x 10 ml
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