master formula record analgin injection


master formula record analgin injection




Colour                                              :  Clear, colourless solution.

COMPOSITION                                    : Each ml Contains:

Analgin  500 mg

Chlorbutol  0.4 % w/v


BATCH SIZE                                          : 100 Litres


SELF  LIFE                                              : 2 Years


PACKAGING                                           : 30 ml Amber vial



Sr. No. Raw Materials Qty Per ml Overages Total qty per ml Quantity per batch
01. Analgin 500mg 500mg 50.0kg
02. Sodium Thiosulphate 1.0mg 1.0mg 100.0gm
03. Chlorbutol 4.0mg 4.0mg 400.0gm
04. Benzyl Alcohal 1.5 % v/v 1.5% v/v 1.500 litre
05. Acetic Acid  Glacial 0.1 % 0.1 % 100 ml

CALCULATION : Analgin I.P. 500 mg

– For each ml

–  100
_____________ x 500 mg 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 45 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.
4. Then add sodium thiosulphate , chlorbutol ,benzyl alcohol and then add analgin with continuous stirring.
5. Finally check and adjust the pH between 5.5 to 6.5 with Glacial Acetic Acid.
6. Make up the volume upto 100 litres.

Note – should be kept 5.9 as pH on standings.

Contents                                :  30.5 ml

pH                                        :  5.5 to 6.5

Assay                                    :  Analgin I.P. 500mg/ml

Limit 90. % to 110.0%

Theoretical  yield  at  different  stages :

Scheduled fill                                        :             yield           permissible limit


Filling rejection 1.5 %                          :              0 to 2.5%


Optical  checking rejection  6%            :           0 to 8.0 %


Total rejection                                       :


Normal yield                                          :

After optical inspection vials are kept on labeling machine .


PACKING  DETAILS  :        Box of 12  x  30 ml

Outer of 12 x 12 x 30 ml



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 vials have a good aesthetic appearance.


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