standard testing procedure chlorpheniramine maleate

Storage Requirements:
Store protected from light and moisture.
Sampling:
Sample equal quantity from each container / bag. Collect a minimum of 5g from each container/bag sample into individual, self –sealing clear polythene bag kept in another clear self sealing polythene bag bearing ‘Sample for Analysis,lable.After completion of sampling return rest sample on same container. Collect control sample in Pet Bottle/Glass Bottle.
Quantity of Composite Sample:
10 g
Quantity of individual Identification
0.0100 g from each and every container /bag.
Quantity of Control Sample:
2 X 10 g

Description: A white, crystalline powder; odourless.
Solubility: Freely soluble in water; soluble in ethanol (95 per cent); and in chloroform; slightly soluble in ether.
Identification:
Test A may be omitted if tests B, C and D are carried out. Tests B C and D may be omitted if tests
A is carried out
A. By IR.
B. Absorbance at 265nm about 0.42.
C. A blue colour is produced.
D. The crystals melt between 196° and 200°
Appearance of solution: A 10.0 per cent w/v solution is clear and not more intensely coloured than reference solution BYS6.
pH: 4.0 to 5.0.
Related Substances: Determine by thin layer chromatography
Apply to the plate 10µl of each solution. After development dry the plate in air and examine in ultraviolet light at 254 nm. Any secondary spot in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram obtained with the reference solution .Ignore any spot remaining on the line of application.
Sulphated Ash: NMT 0.1%w/w
Loss on drying: NMT 0.5%w/w
Assay: 98.0% to 101.0%w/w on the dried basis.

Description: A white, crystalline powder; odourless.
Procedure: Take the sample and spread in petridish and examine the substance by visually.
Reporting: Report as Complies / does not complies.
Solubility: Freely soluble in water, Soluble in ethanol (95 per cent) and in chloroform, Slightly soluble in ether.
Perform test as per GTP No.
Reporting: Report as Complies/Does not comply.
Identification:
Test A may be omitted if tests B, C and D are carried out. Tests B C and D may be omitted if tests
A is carried out
A. By IR. Determine by infrared absorption spectrophotometer. Compare the spectrum with that obtained with Chlorpheniramine Meleate RS.
Reporting: Report as Complies/Does not comply.
B. When examined in the range 230nm to 360nm , a 0.002 per cent w/v solution in 0.05M sulphuric acid shows an
absorption maximum only at about 265nm ; absorbance at 265nm about 0.42.
Reporting: Report as in value.
C. To 0.2g add 3ml of water and 1ml of 10M sodium hydroxide and extract with three quantities, each of 5ml, of ether.

To 0.1ml of the aqueous layer add a solution of 10mg of resorcinol in 3ml of sulphuric acid and heat in a water-bath for 15minutes;

the solution is colourless. To the reminder of the aqueous layer add 2ml of bromine solution, heat in a water-bath for 15minutes,

heat to boiling and cool. To 0.2ml of the resulting solution add a solution of 10mg of resorcinol in 3ml of sulphuric acid and heat

in a water-bath for 15minutes; a blue colour is produced.
Reporting: Report as Complies/Does not comply.
D. Dissolve 0.1g in 10ml of water and add drop wise with shaking 25ml of a 1per cent w/v solution of picric acid

collect the precipitate on a sintered glass filter , wash with 3ml of ethanol (95 per cent), recrystallise from ethanol (50 per cent) and

dry at 100° to 105°.The crystals melt between 196° and 200°C.
Reporting: Report as Complies/Does not comply.
Appearance of solution: A 10.0 per cent w/v solution is clear and not more intensely coloured than reference solution BYS6.
Perform test as per GTP No
Reporting: Report as Complies/Does not comply.
pH: 4.0 to 5.0, Determined in a 1.0 per cent w/v solution.
Perform test as per GTP No.
Reporting: Report as in value.
Related Substances: Determine by liquid chromatography
Mobile phase: A mixture of 50 volumes of cyclohexane, 40 volumes of chloroform and 10 volumes of diethyl amine.
Test solution: A 5 per cent w/v solution of the substance under examination in chloroform.
Reference solution: Dilute 1 ml of the test solution to 100 ml with chloroform and mix .Dilute 5 ml of the resulting solution to 25 ml with chloroform.
Apply to the plate 10µl of each solution. After development dry the plate in air and examine in ultraviolet light at 254nm.

Any secondary spot in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram

obtained with the reference solution .Ignore any spot remaining on the line of application.
Reporting: Report as Complies/Does not comply.
Sulphated Ash:
Determined 1.0 gm sample in silica crucible ignite for 800ºC and cool add 1 ml of sulphuric acid or ignite & calculated ash.

standard testing procedure chlorpheniramine maleate

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