MFR of cisplatin injection 20ml vial

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3 years ago

NAME OF PRODUCT : 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

MANUFACTURING FORMULA :

BULK MANUFACTURING :

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 5^th of Saline solution seprate. Add this to paste dissolve vigourously & let it settle.
Then decant it into the main 40^th 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 %