Bacampicillin Hydrochloride for Oral Suspension
»Bacampicillin Hydrochloride for Oral Suspension contains an amount of Bacampicillin Hydrochloride equivalent to not less than 90.0percent and not more than 125.0percent of the labeled amount of ampicillin (C16H19N3O4S)when constituted as directed.It contains one or more suitable buffers,colors,flavors,suspending agents,and sweetening ingredients.
Packaging and storage— Preserve in tight containers.
Identification— Constitute Bacampicillin Hydrochloride for Oral Suspension as directed in the labeling.Transfer a portion of the resulting suspension,equivalent to about 140mg of ampicillin,to a 100-mLvolumetric flask,add 70mLof alcohol,shake by mechanical means for 30minutes,dilute with alcohol to volume,and mix:the solution so obtained responds to the Identificationtest under Bacampicillin Hydrochloride.
Uniformity of dosage units á905ñ—
FORSOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 6.5and 8.0,in the suspension constituted as directed in the labeling.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at 60for 3hours:it loses not more than 2.0%of its weight.
Assay—
Standard preparation— Using USP Ampicillin RS,prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ.
Assay preparation— Transfer an accurately measured volume of Bacampicillin Hydrochloride for Oral Suspension,constituted as directed in the labeling and free from bubbles,equivalent to about 87.5mg of ampicillin,to a 250-mLvolumetric flask.Add 200mLof a solvent mixture consisting of alcohol and 0.1Mphosphoric acid (4:1).Shake by mechanical means for 30minutes,dilute with the same solvent mixture to volume,and mix.Centrifuge a portion of the resulting suspension.Pipet 4.0mLof the clear solution so obtained into each of two glass-stoppered,125-mLconical flasks.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in mg,of C16H19N3O4Sin each mLof the constituted Bacampicillin Hydrochloride for Oral Suspension taken by the formula:
(0.0625F)(B-I)/V,
in which Vis the volume,in mL,of constituted Bacampicillin Hydrochloride for Oral Suspension taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 213
Phone Number:1-301-816-8335