Sucrose Octaacetate
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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
Sucrose Octaacetate contains NLT 98.0% and NMT 100.5% of sucrose octaacetate (C₂₈H₃₈O₁₉), calculated on the anhydrous basis.
2 IDENTIFICATION
Change to read:
A. ▲Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-May-2020)
3 ASSAY
Procedure
Sample: 100 mg in a 500-mL conical flask
Blank: 50 mL of 70% alcohol
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Residual titration
Titrant: 0.1 N sodium hydroxide VS
Back-titrant: 0.1 N sulfuric acid VS
Endpoint detection: Visual
Analysis:
Dissolve the Sample in 50 mL of 70% alcohol. Neutralize the solution with 0.1 N sodium hydroxide VS using phenolphthalein TS as the indicator. Add 25.0 mL of 0.1 N sodium hydroxide VS, attach an air condenser to the flask, protect from absorption of carbon dioxide, and reflux on a steam bath for 1 h. Remove from the steam bath, cool quickly, and titrate the excess alkali with 0.1 N sulfuric acid VS using phenolphthalein TS as the indicator. Perform a blank determination.
Calculate the percentage of sucrose octaacetate (C₂₈H₃₈O₁₉) in the portion of Sucrose Octaacetate taken. Each mL of 0.1 N sodium hydroxide is equivalent to 8.483 mg of sucrose octaacetate (C₂₈H₃₈O₁₉).
Acceptance criteria: 98.0%–100.5% on the anhydrous basis
4 IMPURITIES
Residue on Ignition 〈281〉: NMT 0.1%
5 SPECIFIC TESTS
Melting Range or Temperature 〈741〉: NLT 78°
Acidity
Sample: 1 g
Analysis: Dissolve the Sample in 20 mL of neutralized alcohol, and add 2 drops of phenolphthalein TS.
Acceptance criteria: NMT 2 drops of 0.1 N sodium hydroxide are required to produce a red color.
Water Determination, Method I 〈921〉: NMT 1.0%
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight containers.
USP Reference Standards 〈11〉
USP Sucrose Octaacetate RS
