master formula record adrenaline tartrate injection
NAME OF PRODUCT : ADRENALINE TARTRATE INJECTION
COMPOSITION : Each ml Contains:
Adrenaline bitartrate 1.0 mg
equivalent to Adrenaline I.P. 1.8 mg
Sodium metabisulphite I.P. 1.0 mg
BATCH SIZE : 100 Litres
SELF LIFE : 1 Year
PACKAGING : 1 ml Amber ampoule
MANUFACTURING FORMULA :
|Sr. No.||Raw Materials||Qty Per ml||Overages||Total qty per ml||Quantity per batch|
|04.||Sodium Chloride||8.0 mg||–||8.0mg||800.0gm|
|05.||Sodium Hydoxide||–||As per Ph|
|06.||Water for injection||q.s.||–||q.s.||q.s.|
BULK MANUFACTURING :
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 for 30 minutes.
4. Then add disodium E.D.T.A.,sodium metabisulphite , Adrenaline bitartrate and then add sodium chloride
with continuous sterring.
5. Finally check and adjust the pH between 2.8 to 3.6 with sodium hydroxide.
6. Make up the volume upto 100 litres.
Note – should be kept 3.8 as pH lower on standings.
Product Name : Adrenaline Tartarate Injection
Self life : 1 Year
Colour : Clear, colourless solution.
Contents : 1.10 ml
pH : 2.8 to 3.6
Assay : Adrenaline Bitartrate 1.0mg
Equivalent to Adrenaline I.P. 1.8mg/ml
Limit 87.5 % to 112.5%
YIELD AND ACCOUNTABILITY :
• Bulk yield (After filtration) between 98 -100 %.
• After Filling, Sealing and visual Inspection completion the % yield is NLT 95%.
After optical inspection ampoules are kept on labeling machine .
PACKING DETAILS :
INPROCESS CONTROLS :
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.