MFR of cisplatin injection 20ml vial


MFR of cisplatin injection 20ml vial




COMPOSITION                                    : Each ml Contains:

Cisplatin I.P. 0.5mg

Sodium chloride I.P. 9.0mg

Water for Injection I.P. q.s.


BATCH SIZE                                          : 100 Litres


SELF  LIFE                                              : 2 Years


PACKAGING                                           : 20 ml Amber vial



Sr. No. Raw Material Qty


Per ml

Overages Total qty

per ml

Quantity per batch
01. Cisplatin  I.P. 0.5mg 6 % 0.53mg 53.0gm
02. Sodium Chloride I.P. 0.9 mg 0.9mg 900.0gm
03. Hydrochloric Acid I.P. 0.2% 0.2% 200.0ml
04. Sodium Hydroxide I.P. As per pH
05. Water for injection I.P. Q.S. Q.S. Q.S.



  • Clean all the equipment /containers required for bulk manufacturing with (teepol/liquid soap) rinse it with tape water and D.M. Water.
  • In the bulk manufacturing area rinsed twice all the above mentioned items with fresh distilled water.
  • Collect 45 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.
  • Then add sodium Chloride with continuous sterring to clear solution.
  • Dissolve cisplatin by pasting with saline solution 10ml and hydrochloric acid 10ml. Keep about 5th of Saline solution seprate. Add this to paste dissolve vigourously & let it settle.
  • Then decant it into the main 40th saline solution and keep on sterring. Again repeate the process till the complete solution check pH..
  • Finaly check and adjust the pH between 3.5 to 6.5 with very very dilute sodium hydroxide and Hydrochloric Acid.
  • Make up the volume upto 100 litres.

Note – should be pH set 3.5 to 3.8 as on standings.

Product  Name                     :  Cisplatin injection I.P. 20ml Vial


Self  life                                : 2 Years


Colour                                   :  Clear, colourless solution.


Contents                                :  20.60 ml


pH                                        :  3.5 to  6.5


Assay                                    :  Cisplatin I.P. 0.5mg


Limit 90.0 % to 110.0%


Theoretical  yield  at  different  stages :


Scheduled fill                                        :  4854      yield           permissible limit


Filling rejection 1.5 %                           :  728       4126            0 to 2.5%


Optical  checking rejection  6%             :  291       3835           0 to 8.0 %


Total rejection                                         :  1019


Normal yield                                            :  3835


After optical inspection ampoules are kept on labeling machine .


PACKING  DETAILS  :  Box of 24  x 20 ml

Outer of  21 x  24 x 20 ml.

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MFR of cisplatin injection 20ml vial


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