Hydroxyzine Hydrochloride Syrup
(Current title—not to change until June 1,2005)
Monograph title change—to become official June 1,2005
See Hydroxyzine Hydrochloride Oral Solution
»Hydroxyzine Hydrochloride Syrup contains 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— Dilute a volume of Syrup,equivalent to about 20mg of hydroxyzine hydrochloride,with 50mLof methanol,and mix.Apply 100µLof this solution and 100µLof a solution in the same medium containing about 350µg of USP Hydroxyzine Hydrochloride RSper mLto a suitable thin-layer chromatographic plate (see Chromatography á621ñ),coated with a 0.25-mm layer of chromatographic silica gel and dried in air for 30minutes followed by drying in vacuum at 140for 30minutes.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of toluene,alcohol,and ammonium hydroxide (150:95:1)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Locate the spots by lightly spraying with potassium iodoplatinate TS:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Uniformity of dosage units á905ñ—
FOR SYRUP PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ—
FOR SYRUP PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
Assay—
Mobile phase andChromatographic system— Proceed as directed in the Assayunder Hydroxyzine Hydrochloride Tablets.
Standard preparation— Dissolve a suitable quantity of USP Hydroxyzine Hydrochloride RS,accurately weighed,in water to obtain a solution having a known concentration of about 100µg per mL.
Assay preparation— Transfer an accurately measured volume of Syrup,equivalent to about 20mg of hydroxyzine hydrochloride,to a 200-mLvolumetric flask,dilute with water to volume,mix,and pass a portion through a polytef membrane filter having a 5-µm or finer porosity.
Procedure— Proceed as directed for Procedurein the Assayunder Hydroxyzine Hydrochloride Tablets.Calculate the quantity,in mg,of hydroxyzine hydrochloride (C21H27ClN2O2·2HCl)in each mLof the Syrup taken by the formula:
0.2(C/V)(rU/rS),
in which Cis the concentration,in µg per mL,of USP Hydroxyzine Hydrochloride RSin the Standard preparation;Vis the volume,in mL,of Syrup taken;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 982
Pharmacopeial Forum:Volume No.29(6)Page 1903
Phone Number:1-301-816-8165
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