Calcium Gluceptate
(kal' see um gloo sep' tate).
C14H26CaO16 (anhydrous) 490.42 Glucoheptonic acid, calcium salt (2:1); Calcium glucoheptonate (1:2) ![]() ![]() ![]() 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 TestsGeneral, Calcium
![]() ![]() 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
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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
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Acceptance criteria:
95.0%102.0% on the dried basis
IMPURITIES
• Chloride and Sulfate, Chloride
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Standard:
1.0 mL of 0.020 N hydrochloric acid
Sample:
1.0 g
Acceptance criteria:
NMT 0.07%
• Chloride and Sulfate, Sulfate
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Standard:
1.0 mL of 0.020 N sulfuric acid
Sample:
2.0 g
Acceptance criteria:
NMT 0.05%
• Heavy Metals
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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
![]() ![]() (See Thermal Analysis
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[NoteThe quantity taken for the determination may be adjusted, if necessary, for instrument sensitivity. Weight loss occurring at temperatures above about 160
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Sample:
1025 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
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Acceptance criteria:
See Table 1.
Table 1
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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2452
Pharmacopeial Forum: Volume No. 27(6) Page 3257
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