Hydroquinone Cream
»Hydroquinone Cream contains not less than 94.0percent and not more than 106.0percent of the labeled amount of hydroquinone (C6H6O2).
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification— Dissolve a portion of Cream equivalent to about 50mg of hydroquinone,in a mixture of equal volumes of methanol and chloroform to make 50mL:a 5-µLportion of this solution responds to Identificationtest Bunder Hydroquinone.
Minimum fill á755ñ: meets the requirements.
Assay—
Standard preparation— Dissolve a suitable quantity of USP Hydroquinone RSin methanol,and dilute quantitatively and stepwise with methanol to obtain a solution having a known concentration of about 10µg per mL.
Assay preparation— Transfer an accurately weighed portion of Cream,equivalent to about 20mg of hydroquinone,to a 100-mLbeaker.Triturate the Cream with 50mLof methanol,and pass the liquid through folded filter paper,previously washed with methanol,into a 500-mLvolumetric flask.Repeat the trituration and filtration.Dilute,by washing the contents of the filter paper with methanol through the paper into the volumetric flask,to volume,and mix.Pipet 25mLof this solution into a 100-mLvolumetric flask,add methanol to volume,and mix.
Procedure— Concomitantly determine the absorbances of the Standard preparationand the Assay preparationin 1-cm cells at the wavelength of maximum absorbance at about 293nm,with a suitable spectrophotometer,using methanol as the blank.Calculate the quantity,in mg,of hydroquinone (C6H6O2)in each g of the Cream taken by the formula:
2000(C/W)(AU/AS),
in which Cis the concentration,in mg per mL,of USP Hydroquinone RSin the Standard preparation;Wis the weight,in g,of Cream taken;and AUand ASare the absorbances of the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 974
Pharmacopeial Forum:Volume No.27(1)Page 1790
Phone Number:1-301-816-8389