Bacampicillin Hydrochloride for Oral Suspension
» Bacampicillin Hydrochloride for Oral Suspension contains an amount of Bacampicillin Hydrochloride equivalent to not less than 90.0 percent and not more than 125.0 percent 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.
') + '&img=../../images/v35300/cas-69-53-4.gif',600,500);)
') + '&img=../../images/v35300/cas-37661-08-8.gif',600,500);)
Identification—
Constitute Bacampicillin Hydrochloride for Oral Suspension as directed in the labeling. Transfer a portion of the resulting suspension, equivalent to about 140 mg of ampicillin, to a 100-mL volumetric flask, add 70 mL of alcohol, shake by mechanical means for 30 minutes, dilute with alcohol to volume, and mix: the solution so obtained responds to the Identification test under Bacampicillin Hydrochloride.
Uniformity of dosage units 
905
—
905—
For solid packaged in single-unit containers:
meets the requirements.
Deliverable volume 698:
meets the requirements.
698:
meets the requirements.
pH 791:
between 6.5 and 8.0, in the suspension constituted as directed in the labeling.
791:
between 6.5 and 8.0, in the suspension constituted as directed in the labeling.
Loss on drying 731—
Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at 60
for 3 hours: it loses not more than 2.0% of its weight.
731—
Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 2.0% of its weight.
Assay—
Standard preparation—
Using USP Ampicillin RS, prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 425.
425.
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 87.5 mg of ampicillin, to a 250-mL volumetric flask. Add 200 mL of a solvent mixture consisting of alcohol and 0.1 M phosphoric acid (4:1). Shake by mechanical means for 30 minutes, dilute with the same solvent mixture to volume, and mix. Centrifuge a portion of the resulting suspension. Pipet 4.0 mL of the clear solution so obtained into each of two glass-stoppered, 125-mL conical flasks.
Procedure—
Proceed as directed for Procedure under Iodometric Assay—Antibiotics 425. Calculate the quantity, in mg, of C16H19N3O4S in each mL of the constituted Bacampicillin Hydrochloride for Oral Suspension taken by the formula:
425. Calculate the quantity, in mg, of C16H19N3O4S in each mL of the constituted Bacampicillin Hydrochloride for Oral Suspension taken by the formula:
(0.0625F)(B 
I) / V
in which V is the volume, in mL, of constituted Bacampicillin Hydrochloride for Oral Suspension taken, and the other terms are as defined therein.
I) / V
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2293