master formula record ascorbic acid injection
NAME OF PRODUCT : 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
MANUFACTURING FORMULA :
|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|
|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
_____________ x100 mg x 100 Litres
– (Assay – Water)
– ( Assay according to Quality Control Report)
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 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
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.