Sodium Dehydroacetate
C8H7NaO4 190.13
2H-Pyran-2,4(3H)-dione, 3-acetyl-6-methyl-, monosodium salt
[4418-26-2].
(soe' dee um dee hye'' droe as' e tate).
C8H7NaO4 190.13
2H-Pyran-2,4(3H)-dione, 3-acetyl-6-methyl-, monosodium salt
[4418-26-2].DEFINITION
Sodium Dehydroacetate contains NLT 98.0% and NMT 100.5% of sodium dehydroacetate (C8H7NaO4), calculated on the anhydrous basis.
IDENTIFICATION
• A. Melting Range or Temperature 
741
741
Sample solution:
150 mg/mL
Analysis:
To 10 mL of the Sample solution 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 h. Determine the melting point as directed in the chapter.
for 4 h. Determine the melting point as directed in the chapter.
Acceptance criteria:
109–111
–111
• B. Identification Tests—General, Sodium 191
191
Sample solution:
1 in 20
Acceptance criteria:
Meets the requirements
ASSAY
• Procedure
Sample:
500 mg
Blank:
25 mL of glacial acetic acid containing p-naphtholbenzein TS, which has been previously neutralized to a blue color
Titrimetric system
(See Titrimetry 541.)
541.)
Mode:
Direct titration
Titrant:
0.1 N perchloric acid VS
Endpoint detection:
Visual
Analysis:
Transfer the Sample to a 125-mL conical flask, and dissolve it in 25 mL of glacial acetic acid containing p-naphtholbenzein TS, which has been previously neutralized to a blue color. Titrate with 0.1 N perchloric acid VS to the original blue color. Perform a blank determination.
Calculate the percentage of dehydroacetate (C8H7NaO4) in the Sample taken:
Result = {[(VS 
VB) × N × F]/W} × 100
VB) × N × F]/W} × 100| VS | = | = volume of the Titrant consumed by the Sample (mL) |
| VB | = | = volume of the Titrant consumed by the Blank (mL) |
| N | = | = actual normality of the Titrant (mEq/mL) |
| F | = | = equivalency factor, 190.1 mg/mEq |
| W | = | = weight of the Sample (mg) |
Acceptance criteria:
98.0%–100.5% on the anhydrous basis
IMPURITIES
• Heavy Metals, Method II 231:
NMT 10 ppm
231:
NMT 10 ppm
SPECIFIC TESTS
• Water Determination, Method I 921:
8.5%–10.0%
921:
8.5%–10.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 1954