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Orange Syrup
»Orange Syrup contains,in each 100mL,not less than 450mg and not more than 550mg of citric acid (C6H8O7).
Prepare Orange Syrup as follows (see Pharmaceutical Compounding—Nonsterile Preparationsá795ñ):
Triturate Talc with Tincture and Citric Acid,and gradually add 400mLof Purified Water.Filter,returning the first portions of the filtrate until it becomes clear,and wash the mortar and the filter with sufficient Purified Water to make the filtrate measure 450mL.Dissolve Sucrose in this filtrate by agitation,without heating,and add Purified Water to make the product measure 1000mL.Mix,and strain.
NOTE—Do not use Orange Syrup that has a terebinthine odor or taste or shows other indications of deterioration.
Packaging and storage—
Preserve in tight containers,and store in a cold place.
Labeling—
The label states the Latin binomial and,following the official name,the part of the plant source from which the article was derived.The label indicates that Syrup is not to be used if it has a terebinthine odor or taste or shows other indications of deterioration.
Assay for citric acid—
To 20.0mLof Syrup add 20mLof water,add phenolphthalein TS,and titrate with 0.1Nsodium hydroxide VS.Each mLof 0.1Nsodium hydroxide is equivalent to 6.404mg of citric acid (C6H8O7).
Auxiliary Information—
Staff Liaison:Claudia C.Okeke,Ph.D.,Associate Director
Expert Committee:(CRX)Compounding Pharmacy
USP28–NF23Page 3045
Pharmacopeial Forum:Volume No.27(4)Page 2801
Phone Number:1-301-816-8243
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