Calcium Levulinate
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.
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
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Chromatographic Column
USP32NF27 Page 1768
Pharmacopeial Forum: Volume No. 27(6) Page 3260
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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