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
MANUFACTURING FORMULA :
| Sr.
No. |
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 |
BULK MANUFACTURING :
- 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.
- Collect 60 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.
- Then add Benzyl alcohal.,sodium metabisulphite , Atropine sulphate with continuous sterring.
- Collect 2 litres fresh distilled water in flask and then glacial acetic acid and sodium acetate.
- Then add solution no. 4 add solution no. 5 and then sodium chloride with continuous stirring.
- Finally check pH 5.2 and adjust the pH between 3.0 to 5.5 with sodium acetate.
- 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
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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