master formula record betamethasone sodium phosphate injection



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




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 )
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



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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