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 %
Total rejection : 6817
Normal yield : 84092
After optical inspection ampoules are kept on labeling machine .
PACKING DETAILS : Box of 50 x 1 ml
Outer of 100 x 50 x 1ml
INPROCESS CONTROLS :
PRINTING :
At the start of the batch the printing of the labels should be checked and signed by competent person.
LABELLING :
Periodic check has to be done so that the labeled ampoules have a good aesthetic appearance.
master formula record betamethasone sodium phosphate injection
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