» 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 CompoundingNonsterile Preparations 795):
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.
noteDo 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.
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).
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USP32NF27 Page 1294Pharmacopeial Forum: Volume No. 27(4) Page 2801