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Sodium Dehydroacetate
C8H7NaO4 190.13

2H-Pyran-2,4(3H)-dione, 3-acetyl-6-methyl-, monosodium salt [4418-26-2].
» Sodium Dehydroacetate contains not less than 98.0 percent and not more than 100.5 percent of C8H7NaO4, calculated on the anhydrous basis.
Packaging and storage— Preserve in well-closed containers.
Identification—
A: Dissolve about 1.5 g in 10 mL of water, add 5 mL of 3 N hydrochloric acid, collect the crystals by filtration with suction, wash with 10 mL of water, and dry at 80 for 4 hours: the crystals so obtained melt between 109 and 111 (see Melting Range or Temperature 741).
B: A solution (1 in 20) responds to the tests for Sodium 191.
Water, Method I 921: between 8.5% and 10.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer to a 125-mL conical flask about 500 mg of Sodium Dehydroacetate, accurately weighed, dissolve it in 25 mL of glacial acetic acid containing p-naphtholbenzein TS which has been previously neutralized to a blue color, and titrate with 0.1 N perchloric acid VS to the original blue color. Each mL of 0.1 N perchloric acid is equivalent to 19.01 mg of C8H7NaO4.
Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 3423
Phone Number : 1-301-816-8262