master formula record chlorpheniramine maleate injection


master formula record chlorpheniramine maleate injection


NAME    OF   PRODUCT                     : CHLORPHENIRAMINE MALEATE  INJECTION                                                                                                                                                          

COMPOSITION                                    : Each ml Contains:

Chlorpheniramine Maleate I.P. 10 mg

Water for injection I.P.  q.s.

BATCH SIZE                                          : 100 Litres

SELF  LIFE                                             : 2 Years

PACKAGING                                         : 1 ml Amber ampoule




Raw Materials Qty

Per ml

Overages Total qty

per ml

Quantity per batch
01. Chlorpheniramine maleate I.P. 10.0mg 2 % 10.2mg 1.020 kg
02. Sodium Metabisulphite I.P. 0.50mg 0.50mg 50.0 gm
03. Disodium EDTA I.P. 0.20mg 0.20mg 20.0gm
04. Benzyl alcohol I.P. 1.5% 1.5% 1.50 liter
05. Maleic Acid I.P. 0.16 mg 0.16 mg 16.0gm
06. Water for injection I.P. Q.S. Q.S. Q.S.

CALCULATION    :    Chlorpheniramine maleate I.P.10.0mg

—  For each ml

—         100

—    _____________  x10 mg x 100 Litres

—   (Assay – Water)


—- ( Assay according to Quality Control Report )


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 30 minutes.
4. Then add disodium E.D.T.A.and then add Benzyl alcohol with continuous sterring,solution A .
5.Collect 2 litres fresh disttiled water in flosk then add sodium metabisulphite ,solution B.
6.Collect solution A and B then add Chlor pheniramine maleate with continuous sterring.
7. Finaly check pH 4.75 and adjust the pH between 4.0 to 5.2 with maleic Acid.
8. Make up the volume upto 100 litres.

Product  Name                     : Chlopheniramine Maleate injection

Self  life                                :  2Years

Colour                                   :  Clear, colourless solution.

Contents                                :  1.10 ml

pH                                        :  4.0 to  5.2

Assay                                    :  Chlorpheniramine Maleate I.P. 10mg/ml

Limit 90.0 % to 110.0%

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



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.


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