Hydroxyzine Pamoate Oral Suspension
»Hydroxyzine Pamoate Oral Suspension contains hydroxyzine pamoate (C21H27ClN2O2·C23H16O6)equivalent to not less than 90.0percent and not more than 110.0percent 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 100mg of hydroxyzine pamoate,in a mixture of 25mLof 0.1Nsodium hydroxide and 25mLof acetone,and filter:a 10-µLportion of the filtrate responds to Identificationtest Bunder Hydroxyzine Pamoate.
Uniformity of dosage units á905ñ—
FOR ORAL SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ—
FOR ORAL SUSPENSION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
pHá791ñ: between 4.5and 7.0.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Hydroxyzine Pamoate Capsules.
Assay preparation— Transfer an accurately measured volume of Oral Suspension,freshly mixed and free from air bubbles,equivalent to about 25mg of hydroxyzine hydrochloride,to a 250-mLvolumetric 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 Procedurein the Assayunder Hydroxyzine Pamoate Capsules.Calculate the equivalent quantity,in mg,of hydroxyzine hydrochloride (C21H27ClN2O2·2HCl)in each mLof the Oral Suspension taken by the formula:
(447.83/763.27)(250C/V)(rU/rS),
in which Vis the volume,in mL,of Oral Suspension taken;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 984
Pharmacopeial Forum:Volume No.29(6)Page 1904
Phone Number:1-301-816-8165
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