MFR of Atropine sulphate injection


MFR of Atropine sulphate injection


NAME    OF   PRODUCT                     : Atropine sulphate injection 1 ml ampoule


COMPOSITION                                    : Each ml Contains:

Atropine Sulphate  0.6 mg/ml

Water for injection Q.S.


BATCH SIZE                                          : 100 Litres


SELF  LIFE                                              : 2 Years


PACKAGING                                           : 1 ml White ampoule





Raw Materials Qty

Per ml

Overages Total Qty.

per ml

Quantity per batch
01. Atropine Sulphate 0.6mg 7 % 0.642mg 64.2gm
02. Sodium Metabisulphite 1.0mg 1.0mg 100.0gm
03. Benzyl Alcohal 0.1% 01% 1.0 litre
04. Sodium Chloride 9.0 mg 9.0mg 900.0gm
05. Sodium Acetate 3.0mg 3.0mg 300gm
06. Glacial acetic acid 0.03% 0.03% 30 ml



  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.

  1. Collect 60 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.
  2. Then add Benzyl alcohal.,sodium metabisulphite , Atropine sulphate with continuous sterring.
  3. Collect 2 litres fresh distilled water in flask and then glacial acetic acid and sodium acetate.
  4. Then add solution no. 4 add solution no. 5 and then sodium chloride with continuous stirring.
  5. Finally check pH 5.2 and adjust the pH between 3.0 to 5.5 with sodium acetate.
  6. Make up the volume upto 100 litres.



Product  Name                      :           Atropine sulphate injection 1 ml ampoule


Self  life                                :           2 Years

Colour                                   :           Clear, colourless solution.


Contents                                :           1.10 ml


pH                                        :           3.0 to  5.5


Assay                                    :           Atropine sulphate  I.P. 0.6mg


Limit 90 % to 110 %


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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