Calcium Gluceptate
(kal' see um gloo sep' tate).
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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 NLT 95.0% and NMT 102.0% of calcium gluceptate (C14H26CaO16), calculated on the dried basis.
•  B. Identification Tests—General, Calcium 191: A 20-mg/mL solution meets the requirements.
•  Procedure
Sample:  800 mg of Calcium Gluceptate
Blank:  150 mL of water containing 2 mL of 3 N hydrochloric acid
Titrimetric system 
Mode:  Direct titration
Titrant:  0.05 M edetate disodium VS
Endpoint detection:  Visual
Analysis:  Dissolve the Sample with 150 mL of water containing 2 mL of 3 N hydrochloric acid. While stirring, preferably with a magnetic stirrer, add 25 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 gluceptate (C14H26CaO16) in the Sample taken:
Result = {[(VS VB) × M × F]/W} × 100
VS== Titrant volume consumed by the Sample (mL)
VB== Titrant volume consumed by the Blank (mL)
M== actual molarity of the Titrant (mM/mL)
F== equivalency factor, 490.4 mg/mM
W== Sample weight (mg)
Acceptance criteria:  95.0%–102.0% on the dried basis
•  Chloride and Sulfate, Chloride 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
Standard:  1.0 mL of 0.020 N sulfuric acid
Sample:  2.0 g
Acceptance criteria:  NMT 0.05%
•  Heavy Metals 231
Test preparation:  Dissolve 1 g in 25 mL of water.
Acceptance criteria:  NMT 20 ppm
•  Reducing Sugars
Sample:  0.50 g
Analysis:  Dissolve the Sample in 10 mL of hot 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.
•  pH 791
Sample solution:  100 mg/mL
Acceptance criteria:  6.0–8.0
•  Loss on Drying 731
[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. ]
Sample:  10–25 mg
Analysis:  Determine the percentage of volatile substances by thermogravimetric analysis on an appropriately calibrated instrument. Heat the specimen under test at a rate of 5/min in an atmosphere of nitrogen, at a flow rate of 40 mL/min. Record the thermogram to 150.
Acceptance criteria:  See Table 1.
Table 1
Form Loss on Drying (%)
Anhydrous NMT 1.0
2H2O (dihydrate) NMT 6.9
31/2H2O NMT 11.4
•  Packaging and Storage: Preserve in well-closed containers.
•  Labeling: Label to indicate whether hydrous or anhydrous; if hydrous, label to indicate also the degree of hydration.
•  USP Reference Standards 11
USP Calcium Gluceptate RS Click to View Structure
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USP35–NF30 Page 2452
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