STP FOR CHLORPHENIRAMINE MALEATE,DEXTROMETHORPHEN HBR, PHENYLEPHRINE HCL SYRUP

nirvesh400
  • Description: Visual
  • Average filled volume: Not less than labeled claim.

Take 10 bottles of the product and measure the volumes separately of each bottle with calibrated or certified volumetric flask.

3.0)                  Uniformity of Volume: Randomly pick up sample and check its Average volume.

        The average net volume of the contents of the containers is not less than the labeled volume, and the net volume of the contents of any single containers is not less than 91 per cent and not more than 109 per cent of the labeled volume where the labeled volume is 50ml or less, or not less than 95.5 per cent and not more than 104.5 per cent of the labeled volume where the labeled volume is more than 50ml but not more than 200ml, or not less than 97 per cent but not more than 103 per cent of the labeled volume where the labeled volume is more than 200ml but not more than 300ml.

If this requirement is not met, determined the net volume of the contents of 10 additional containers. The average net volume of the contents of the 20 containers is not less than the labeled volume, and the net volume of the content of not more than 1 of 20 containers is less than 91 per cent or more than 109 per cent of the labeled volume where the labeled volume is 50ml or less, or not less than 95.5 per cent and not more than 104.5 per cent of the labeled volume where the labeled volume is more than 50ml but not more than 200ml, or not less than 97 per cent but not more than 103 per cent of the labeled volume where the labeled volume is more than 200ml but not more than 300ml. None of individual weights deviates by more than twice that of respective minimum and maximum percentage limits.

  • Identification Test:

In the assay, the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.

 

5.0)      pH:   4.5 to 5.5

6.0)      Leak test:

The apparatus is used to test for the integrity of packed syrup bottles. Ensure apparatus bath is filled with purified water upto mark indicated and add 0.5% crystal violet solution in water. Samples are placed into the desiccators and the lid is placed in position. The pump starts to produce a vacuum 15inHg inside the desiccators and the vacuum is held for 1 minute. The sample remains at the required vacuum level for given time interval buzzer will sound after time is over and will cut off the vacuum pump. As the package is immersed in a colored dye solution the venting of the desiccators will allow any holes to be penetrated by the dye and the contents of the flexible packaging will also be stained with the same coloring material.

Examine all the bottles for any leakage by opening the bottles manually. If anyone bottle shows evidence of leakage, reject the sample, stop the machine and immediately take corrective action.

7.0)      Assay: Determined by liquid chromatography.

Test solution: Take 2 ml test sample in 100 ml volumetric flask and add 10 ml of mobile phase and sonicate for 10 minutes. Make up to the mark with mobile phase and stir the solution. Filter the solution with 0.4 µ filter.

Reference solution: Weigh 20 mg of Chlorpheniramine maleate, 50 mg Phenylephrine and 105 mg Dextromethorphan HBr in 100 ml volumetric flask and add 10 ml mobile phase and sonicate for 10 minutes. Make up to the mark with mobile phase and dilute 1 ml of solution to 25 ml with mobile phase and sonicate for 5 minutes .Filter the solution with 0.4 µ filter.

            Chromatographic system:

  • A stainless steel column 250 cm X 4.6 mm, packed with octadecylsilane bonded to porous silica (5 µm).
  • Mobile phase: Take 600 ml HPLC Water and add 400 ml Acetonitrile, 1 ml Triethylamine, adjust PH 3.5 with Orthophosphoric acid.
  • Flow rate: 0.8 ml per minute.
  • Spectrophotometer set at 220 nm,
  • Injection volume: about 20 µl

Inject reference solution and test solution.

Calculate the content of Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephiramine HCl.

Acceptance criteria: 90.0%-110.0%

8.0)      MICROBIOLOGICAL PURITY:

            Perform the test according to requirements of IP,

Total aerobic Microbial count (TAMC): NMT 103 CFU/g

Total combined yeasts/Moulds count (TYMC): NMT 102 CFU/g

Pathogens: in 1gm drug.

Escherichia Coli – Should be absent

Pseudomonas aeroginosa – Should be absent

Salmonella – Should be absent

Staphylococcus aureus– Should be absent

 

9.0)    Abbreviations:

Wt.: Weight

CFU: Colony Forming Unit

mg: Milligram

ml: Millilitre

w/v: Weight/Volume

inHg: Inch of Mercury

 

 

STP