Orange Syrup
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Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Orange Syrup contains NLT 0.45% and NMT 0.55% of citric acid (C6H8O7).
Prepare Orange Syrup as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).
| Sweet Orange Peel Tincture | 50 mL |
Anhydrous Citric Acid | 5 g |
Talc | 15 g |
Sucrose | 820 g |
Purified Water, a sufficient quantity to make | 1000 mL |
Triturate Talc with Sweet Orange Peel Tincture and Anhydrous 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 succulent 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.]
2 ASSAY
Citric Acid
Sample: 20 mL
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Direct titration
Titrant: 0.1 N sodium hydroxide VS
Endpoint detection: Visual
Analysis: To the Sample add 20 mL of water and add phenolphthalein TS. Titrate with Titrant. Each mL of Titrant is equivalent to 6.404 mg of citric acid (C6H8O7).
Acceptance criteria: 0.45%–0.55%
3 OTHER COMPONENTS
Alcohol Determination, Method I 〈611〉: 2.0%–5.0%
4 ADDITIONAL REQUIREMENTS
Packaging and Storage: Package 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.
