Colestipol Hydrochloride for Oral Suspension
»Colestipol Hydrochloride for Oral Suspension is a mixture of Colestipol Hydrochloride with a suitable flow-promoting agent.Each g binds not less than 1.1mEq and not more than 1.6mEq of sodium cholate,calculated as the cholate binding capacity.
Packaging and storage—
Preserve in tight,single-dose or multiple-dose containers.
Minimum fill á755ñ:
meets the requirements for powders.
Water-soluble substances—
Transfer 5.0g of Colestipol Hydrochloride for Oral Suspension,accurately weighed,to a glass-stoppered,125-mLconical flask,add 80.0mLof water,insert the stopper in the flask,and mount the flask in a water-bath shaker maintained at 37±1
.Operate the shaker for 72hours,remove the flask from the shaker,and filter the contents through a fine-porosity,fritted-glass funnel,collecting the filtrate in a tared 100-mLfused quartz crucible.Rinse any residual test material in the flask with two 5-mLportions of water,pass the washings through the filter,and combine the filtrates from the washings with the filtrate from the test mixture.Evaporate the filtrate to dryness,filtered air or nitrogen being used,if necessary,to aid in the evaporation.Dry the residue in a vacuum oven maintained at 75for 1hour,allow to cool in a desiccator,and weigh.Calculate the initial percentage of water-soluble substances in the portion of Colestipol Hydrochloride for Oral Suspension taken.Again heat the residue in a muffle furnace maintained at 800±25for 4hours,allow to cool in a desiccator,and weigh.Calculate the percentage of inert ingredients present.Calculate the actual percentage of water-soluble substances in the portion of Colestipol Hydrochloride for Oral Suspension taken by subtracting the percentage of inert ingredients from the initial percentage of water-soluble substances found.Not more than 0.5%of water-soluble substances is found.
.Operate the shaker for 72hours,remove the flask from the shaker,and filter the contents through a fine-porosity,fritted-glass funnel,collecting the filtrate in a tared 100-mLfused quartz crucible.Rinse any residual test material in the flask with two 5-mLportions of water,pass the washings through the filter,and combine the filtrates from the washings with the filtrate from the test mixture.Evaporate the filtrate to dryness,filtered air or nitrogen being used,if necessary,to aid in the evaporation.Dry the residue in a vacuum oven maintained at 75for 1hour,allow to cool in a desiccator,and weigh.Calculate the initial percentage of water-soluble substances in the portion of Colestipol Hydrochloride for Oral Suspension taken.Again heat the residue in a muffle furnace maintained at 800±25for 4hours,allow to cool in a desiccator,and weigh.Calculate the percentage of inert ingredients present.Calculate the actual percentage of water-soluble substances in the portion of Colestipol Hydrochloride for Oral Suspension taken by subtracting the percentage of inert ingredients from the initial percentage of water-soluble substances found.Not more than 0.5%of water-soluble substances is found.
Other requirements—
Meets the requirements of the tests for Cholate binding capacity,Identification,and pHunder Colestipol Hydrochloride.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 540
Phone Number:1-301-816-8251