Calcium Gluceptate
C14H26CaO16 (anhydrous) 490.42
Glucoheptonic acid, calcium salt (2:1);
Calcium glucoheptonate (1:2)
[29039-00-7].
(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].DEFINITION
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.
IDENTIFICATION
• B. Identification Tests—General, Calcium 
191
:
A 20-mg/mL solution meets the requirements.
191:
A 20-mg/mL solution meets the requirements.
ASSAY
• Procedure
Sample:
800 mg of Calcium Gluceptate
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 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
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
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
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.
SPECIFIC TESTS
• Loss on Drying 731
731
(See Thermal Analysis 891.)
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. ]
, 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.
/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 |
ADDITIONAL REQUIREMENTS
• 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
11
USP Calcium Gluceptate RS 
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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 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2452
Pharmacopeial Forum: Volume No. 27(6) Page 3257