Calcium Gluceptate
Click to View Image
C14H26CaO16 (anhydrous) 490.42

Glucoheptonic acid, calcium salt (2:1).
Calcium glucoheptonate (1:2) [29039-00-7].
» Calcium Gluceptate is anhydrous or contains varying amounts of water of hydration. It consists of the calcium salt of the alpha epimer of glucoheptonic acid or of a mixture of the alpha and beta epimers of glucoheptonic acid. It contains not less than 95.0 percent and not more than 102.0 percent of C14H26 CaO16, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Labeling— Label it to indicate whether it is hydrous or anhydrous; if hydrous, label it to indicate also the degree of hydration.
B: A solution (1 in 50) responds to the tests for Calcium 191.
pH 791: between 6.0 and 8.0, in a solution (1 in 10).
Loss on drying 731 (see Thermal Analysis 891) [note—The quantity taken for the determination may be adjusted, if necessary, for instrument sensitivity. Weight loss occurring at temperatures above about 160, indicative of decomposition, is not to be interpreted as Loss on drying.] Determine the percentage of volatile substances by thermogravimetric analysis on an appropriately calibrated instrument, using 10 to 25 mg of Calcium Gluceptate accurately weighed. Heat the specimen under test at a rate of 5 per minute in an atmosphere of nitrogen, at a flow rate of 40 mL per minute. Record the thermogram to 150: the anhydrous form loses not more than 1.0%, the 2H2O form not more than 6.9%, and the 3½H2O form not more than 11.4%, 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 Dissolve 1 g in 25 mL of water: the limit is 0.002%.
Reducing sugars— Dissolve 0.50 g in 10 mL of hot 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 800 mg of Calcium Gluceptate, accurately weighed, in 150 mL of water containing 2 mL of 3 N hydrochloric acid. While stirring, preferably with a magnetic stirrer, add about 25 mL of 0.05 M edetate disodium VS from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 24.52 mg of C14H26CaO16.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Curtis Phinney

(DSN05) Dietary Supplements - Non-Botanicals
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1763
Pharmacopeial Forum: Volume No. 27(6) Page 3257
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.