master formula record betamethasone sodium phosphate injection

NAME OF PRODUCT : BETAMETHASONE SODIUM PHOSPHATE INJECTION

COMPOSITION : Each ml Contains:

Betamethasone sodium phosphate 4.0 mg

equivalent to Betamethasone 4.52mg

Water for injection Q.S.

BATCH SIZE : 100 Litres

SELF LIFE : 1.5 Years

PACKAGING : 1 ml White ampoule

MANUFACTURING FORMULA :

Sr. No.	Raw Materials	Qty Per ml	Overages	Total Qty Per ml	Quantity Per batch
01.	Betamethasone sod.Phos.I.P.	5.2mg	11%	5.772mg	577.2gm
02.	Sodium Metabisulphite I.P.	3.2mg	–	3.2mg	320.0gm
03.	Disodium EDTA I.P.	0.1mg	–	0.1mg	10.0gm
04.	Disodium hydrogen phos. I.P.	10.0 mg	–	10.0mg	1000.0gm
05.	Sodium Hydoxide I.P.	1.0 mg	–	1.0mg	100.0gm
06.	Phenol I.P.	0.5%	–	0.5%	500.0ml
07.	Water for injection I.P.	Q.S.	–	Q.S.	Q.S.

CALCULATION : Betamethasone sodium phosphate I.P4.0mg

Equivalente to Betametasone 4.52 mg

For each ml

– – 100

– – _____________ x 4mg 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 60 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.
4) Then add disodium E.D.T.A.,sodium metabisulphite , Phenol , disodium hydrogen phosphate and then add Betamethasone with continuous stirring.
5) Finaly check pH8.5 and adjust the pH between 7.5 to 9.0 with sodium hydroxide.
6) Make up the volume upto 100 litres.

Product Name : Betametasone sodium phosphate injection 1 ml ampoule

Self life : 1.5 Years

Colour : Clear, colourless solution.

Contents : 1.10 ml

pH : 7.5 to 9.0

Assay : Betamethasone sodium phosphate I.P.4.0 mg/ml

Equivalent to Betamethasone 4.52mg/ml

Limit 92.5 % to 107.5%

Theoretical yield at different stages :

Scheduled fill : 90909 yield permissible limit

Filling rejection 1.5 % : 1363 89546 0 to 2.5%

Optical checking rejection 6% : 5454 84092 0 to 8.0 %