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
01.	Adrenaline bitartarete	1.8mg	8%	1.94mg	194.4gm
02.	Sodium Metabisulphite	1.0mg	–	1.0mg	100.0gm
03.	Disodium EDTA	0.5mg	–	0.5mg	50.0gm
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 :

PRINTING :
At the start of the batch the printing of the labels should be checked and signed by competent person.

LABELLING :
Periodic check has to be done so that the labeled ampoules have a good aesthetic appearance.

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