U.S. PHARMACOPEIA

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Orange Syrup
» Orange Syrup contains, in each 100 mL, not less than 450 mg and not more than 550 mg of citric acid (C6H8O7).
Prepare Orange Syrup as follows (see Pharmaceutical Compounding—Nonsterile Preparations 795):
Sweet Orange Peel Tincture 50 mL
Citric Acid (anhydrous) 5 g
Talc 15 g
Sucrose 820 g
Purified Water, a sufficient quantity,
to make		 1000 mL
Triturate Talc with Tincture and Citric Acid, and gradually add 400 mL of 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 450 mL. Dissolve Sucrose in this filtrate by agitation, without heating, and add Purified Water to make the product measure 1000 mL. 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.
Alcohol content, Method I 611: between 2.0% and 5.0% of C2H5OH.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for citric acid— To 20.0 mL of Syrup add 20 mL of water, add phenolphthalein TS, and titrate with 0.1 N sodium hydroxide VS. Each mL of 0.1 N sodium hydroxide is equivalent to 6.404 mg of citric acid (C6H8O7).
Auxiliary Information— Staff Liaison : Claudia C. Okeke, Ph.D., Associate Director
Expert Committee : (CRX05) Compounding Pharmacy05
USP29–NF24 Page 3385
Pharmacopeial Forum : Volume No. 27(4) Page 2801
Phone Number : 1-301-816-8243