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Calcium Levulinate
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C10H14CaO6·2H2O 306.32

Pentanoic acid, 4-oxo-, calcium salt (2:1), dihydrate.
Calcium levulinate (1:2) dihydrate [5743-49-7].

Anhydrous 270.30 [591-64-0].
» Calcium Levulinate contains not less than 97.5 percent and not more than 100.5 percent of C10H14CaO6, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification—
A: A solution (1 in 10) responds to the tests for Calcium 191.
B: To a solution of 0.5 g in 5 mL of water add 5 mL of 1 N sodium hydroxide, and filter. To the filtrate add 5 mL of iodine TS: a precipitate of iodoform is produced.
Melting range, Class I 741: between 119 and 125.
pH 791: between 7.0 and 8.5, in a solution (1 in 10).
Loss on drying 731 Dry it at a pressure not exceeding 5 mm of mercury at 60 for 5 hours: it loses between 10.5% and 12.0% of its weight.
Chloride 221 A 1.0-g portion shows no more chloride than corresponds to 1.0 mL of 0.020 N hydrochloric acid (0.07%).
Sulfate 221 A 2.0-g portion shows no more sulfate than corresponds to 1.0 mL of 0.020 N sulfuric acid (0.05%).
Heavy metals 231: 0.002%.
Reducing sugars— Dissolve 0.50 g in 10 mL of water, add 2 mL of 3 N hydrochloric acid, boil for about 2 minutes, and cool. Add 5 mL of sodium carbonate TS, allow to stand for 5 minutes, dilute with water to 20 mL, and filter. Add 5 mL of the clear filtrate to about 2 mL of alkaline cupric tartrate TS, and boil for 1 minute: no red precipitate is formed immediately.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 600 mg of Calcium Levulinate, accurately weighed, in 150 mL of water containing 2 mL of 3 N hydrochloric acid. While stirring with a magnetic stirrer, add 30 mL of 0.05 M edetate disodium VS from a 50-mL buret, followed by 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to the blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 13.51 mg of C10H14CaO6.
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 358
Pharmacopeial Forum : Volume No. 27(6) Page 3260
Phone Number : 1-301-816-8389