master formula record ascorbic acid injection


master formula record ascorbic acid injection


COMPOSITION : Each ml Contains:
Ascorbic Acid I.P.100 mg/ml
Water for injection I.P. q.s.

BATCH SIZE : 100 Litres

SELF LIFE : 1.5 Years

PACKAGING : 5 ml Amber ampoule


Sr. No. Raw Materials Qty Per ml Overages Total qty per ml Quantity per batch
01. Ascorbic Acid 100mg 6.0% 106mg 10.6 kg
02. Sodium Hydroxide 2.425% 2.425% 2.425kg
03. Methyl paraben 0.08mg 0.08mg 80.0gm
04. Propyl paraben 0.01 mg 0.01mg 10.0gm
05. Water for injection Q.S. Q.S. Q.S.

CALCULATION    :    Ascorbic Acid I.P.100.0mg/ml


For each ml


–    100

_____________  x100 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 20 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.

Then add Sodium hydroxide stir to dissolve.Lid tightly and keep it over night solution no. 1.
4) Collect 50 litres water for injection heat to boil.Then add propyl paraben and stir well to clear solution.

Then add methyl paraben and stir well to dissolve. Keep it over night in sterile area solution no. 2.
5) Next day take second part in the tank and start nitrogen flushing 30 minutes.Then add Ascorbic Acid

slowly and stir till clear solution with continuous stirring.
6) Then add sodium hydroxide pouring small quantity along with vigorous stering. Ring with fresh

water for injection and again add to Ascorbic Acid.Check the pH to abaut 7.0.
7) Finally check and adjust the pH between 5.0 to 7.0 with sodium hydroxide and ascorbic acid.
8) Make-up the volume upto 100 litres.

Product  Name                     : Ascorbic Acid injection  5 ml ampoule


Self  life                                : 1.5 Years


Colour                                   :  Clear, colurless solution.


Contents                                :  5.3 ml


pH                                        :  5.0 to  7.0


Assay                                    :  Ascorbic Acid  100mg/ml


Limit 95.0 % to 115.0%


Theoretical  yield  at  different  stages :

Scheduled fill                                        :       yield           permissible limit


Filling rejection 1.5 %                          :            0 to 2.5%


Optical  checking rejection  6%            :            0 to 6.0 %


Total rejection                                       :


Normal yield                                          :


After optical inspection ampoules are kept on labeling machine .


PACKING  DETAILS  :  Box of 50  x 5 ml

Outer of 10 x 50 x 5ml





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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