Hydroxyzine Pamoate Oral Suspension
» Hydroxyzine Pamoate Oral Suspension contains hydroxyzine pamoate (C21H27ClN2O2·C23H16O6) equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydroxyzine hydrochloride (C21H27ClN2O2·2HCl).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— Dissolve a portion of Oral Suspension, equivalent to about 100 mg of hydroxyzine pamoate, in a mixture of 25 mL of 0.1 N sodium hydroxide and 25 mL of acetone, and filter: a 10-µL portion of the filtrate responds to Identification test B under Hydroxyzine Pamoate.
Uniformity of dosage units 905—
for oral suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698—
for oral suspension packaged in multiple-unit containers: meets the requirements.
pH 791: between 4.5 and 7.0.
Assay—
Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Hydroxyzine Pamoate Capsules.
Assay preparation— Transfer an accurately measured volume of Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 25 mg of hydroxyzine hydrochloride, to a 250-mL volumetric flask. Dissolve in and dilute with methanol to volume, and mix. Pass this solution through a polytef membrane filter having a 1-µm or finer porosity.
Procedure— Proceed as directed for Procedure in the Assay under Hydroxyzine Pamoate Capsules. Calculate the equivalent quantity, in mg, of hydroxyzine hydrochloride (C21H27ClN2O2·2HCl) in each mL of the Oral Suspension taken by the formula:
(447.83/763.27)(250C/V)(rU / rS)
in which V is the volume, in mL, of Oral Suspension taken; and the other terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
1-301-816-8330		 (MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 2600
Pharmacopeial Forum: Volume No. 34(2) Page 273
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.