Calcium Levulinate
C10H14CaO6·2H2O 306.32
C10H14CaO6 270.30
Pentanoic acid, 4-oxo-, calcium salt (2:1), dihydrate;
Calcium levulinate (1:2) dihydrate
[5743-49-7].
Anhydrous[591-64-0].
(kal' see um lev'' ue lin' ate).
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C10H14CaO6·2H2O 306.32
C10H14CaO6 270.30
Pentanoic acid, 4-oxo-, calcium salt (2:1), dihydrate;
Calcium levulinate (1:2) dihydrate
[5743-49-7].Anhydrous
[591-64-0].DEFINITION
Calcium Levulinate contains NLT 97.5% and NMT 100.5% of calcium levulinate (C10H14CaO6), calculated on the dried basis.
IDENTIFICATION
• A. Identification Tests—General, Calcium 
191
:
A 100 mg/mL solution meets the requirements.
191:
A 100 mg/mL solution meets the requirements.
• B.
Sample solution:
0.5 g in 5 mL of water
Analysis:
To the Sample solution add 5 mL of 1 N sodium hydroxide, and filter. To the filtrate add 5 mL of iodine TS.
Acceptance criteria:
A precipitate of iodoform is produced.
ASSAY
• Procedure
Sample:
600 mg of Calcium Levulinate
Blank:
150 mL of water containing 2 mL of 3 N hydrochloric acid
Titrimetric system
(See Titrimetry 541.)
541.)
Mode:
Direct titration
Titrant:
0.05 M edetate disodium VS
Endpoint detection:
Visual
Analysis:
Dissolve the Sample in 150 mL of water containing 2 mL of 3 N hydrochloric acid. While stirring with a magnetic stirrer, add 30 mL of Titrant from the titration buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Perform the Blank determination.
Calculate the percentage of calcium levulinate (C10H14CaO6) in the Sample taken:
Result = {[(VS 
VB) × M × F]/W} × 100
VB) × M × F]/W} × 100| VS | = | = Titrant volume consumed by the Sample (mL) |
| VB | = | = Titrant volume consumed by the Blank (mL) |
| M | = | = Titrant molarity (mM/mL) |
| F | = | = equivalency factor, 270.3 mg/mM |
| W | = | = Sample weight (mg) |
Acceptance criteria:
97.5%–100.5% on the dried basis
IMPURITIES
• Chloride and Sulfate, Chloride 221
221
Standard:
1.0 mL of 0.020 N hydrochloric acid
Sample:
1.0 g
Acceptance criteria:
NMT 0.07%
• Chloride and Sulfate, Sulfate 221
221
Standard:
1.0 mL of 0.020 N sulfuric acid
Sample:
2.0 g
Acceptance criteria:
NMT 0.05%
• Heavy Metals 231:
NMT 20 ppm
231:
NMT 20 ppm
• Reducing Sugars
Sample:
0.50 g
Analysis:
Dissolve the Sample in 10 mL of water, add 2 mL of 3 N hydrochloric acid, boil for about 2 min, and cool. Add 5 mL of sodium carbonate TS, allow to stand for 5 min, dilute with water to 20 mL, and filter. Add 5 mL of the clear filtrate to 2 mL of alkaline cupric tartrate TS, and boil for 1 min.
Acceptance criteria:
No red precipitate is formed immediately.
SPECIFIC TESTS
• Melting Range or Temperature, Class I 741:
119
–125
741:
119–125
• Loss on Drying 731:
Dry a sample at a pressure not exceeding 5 mm of mercury at 60 for 5 h: it loses 10.5%–12.0% of its weight.
731:
Dry a sample at a pressure not exceeding 5 mm of mercury at 60 for 5 h: it loses 10.5%–12.0% of its weight.
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 | Huy T. Dinh, M.S.
Scientific Liaison 1-301-816-8594 |
(DS2010) Monographs - Dietary Supplements |
USP35–NF30 Page 2460
Pharmacopeial Forum: Volume No. 27(6) Page 3260