Propylene Carbonate
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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)
C4H6O3 102.09
4-Methyl-1,3-dioxolan-2-one;
Cyclic propylene carbonate CAS RN®: 108-32-7.
1 DEFINITION
Propylene Carbonate contains NLT 99.0% and NMT 100.5% of propylene carbonate (C4H6O3).
2 IDENTIFICATION
A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197F
3 ASSAY
Change to read:
Procedure
Barium hydroxide solution: 75 mg/mL of barium hydroxide (octahydrate). Filter the solution before use.
Sample: 600 mg
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Residual (ERR 1-Jul-2020) titration
Titrant: 0.5 N hydrochloric acid VS
Endpoint detection: Visual
Analysis: Flush a 250-mL iodine flask with nitrogen to expel the air, and insert the stopper in the flask to exclude carbon dioxide. Transfer 50.0 mL of Barium hydroxide solution and the Sample to the flask, and loosely reinsert the stopper. Moisten the stopper with 3 drops of water, and heat the flask on a steam bath for 10 min. Remove the flask from the steam bath, add 6 drops of phenolphthalein TS, and titrate while hot with Titrant until only a trace of pink color remains. Perform a blank determination, using the same Barium hydroxide solution. Each mL of 0.5 N hydrochloric acid consumed is equivalent to 25.52 mg of propylene carbonate (C4H6O3).
Acceptance criteria: 99.0%–100.5%
4 IMPURITIES
Residue on Ignition 〈281〉: NMT 0.01%
5 SPECIFIC TESTS
Specific Gravity 〈841〉: 1.203–1.210 at 20°
pH 〈791〉
Sample solution: Mix 10 mL of propylene carbonate with 0.3 mL of saturated potassium chloride solution in a 100-mL borosilicate volumetric flask. Dilute with carbon dioxide-free water having a pH of 7.0 ± 0.5 to volume.
Analysis: Completely purge the solution by vigorous nitrogen bubbling, and continue the bubbling during the pH measurement. Determine the pH potentiometrically when the reading stabilizes.
Acceptance criteria: 6.0–7.5
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight containers.
USP Reference Standards 〈11〉
USP Propylene Carbonate RS
