master formula record calcium gluconate injection


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




Raw Materials Qty

Per ml

Overages Total qty

per ml

Quantity per batch
01. Calcium Gluconate         100mg 93mg 9.300kg
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


—         100

— _____________  x 9.3 mg  x 100 Litres

—  (Assay – Water)


—  ( Assay according to Quality Control Report )


  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 fresh distilled water in the tank and start boiledand heat.
  4. 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.
  5. Finaly checkpH 8.2 and adjust the pH between 6.0 to 8.2 with sodium hydroxide.
  6. 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



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

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