USP Monographs: Hydroxyzine Pamoate Oral Suspension

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.

USP Reference standards

— USP Hydroxyzine Hydrochloride RS. USP Hydroxyzine Pamoate RS.

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.

791

: between 4.5 and 7.0.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

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— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 1093

Pharmacopeial Forum : Volume No. 29(6) Page 1904

Phone Number : 1-301-816-8330


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