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
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)

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 :