Calcium Gluceptate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₁₄H₂₆CaO₁₆(anhydrous).  490.42

Glucoheptonic acid, calcium salt (2:1);

Calcium glucoheptonate (1:2) CAS RN: 29039-00-7; UNII: L11651398J.

1 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.

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K (CN 1-MAY-2020)

B. IDENTIFICATION TESTS-GENERAL, Calcium (191): A 20-mg/mL solution meets the requirements.

3 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).)

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 300mg 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 = {[(V_S-V_B) x MxF]/W} x 100

V_S = Titrant volume consumed by the Sample (mL)

V_B = 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

4 IMPURITIES

4.1 CHLORIDE AND SULFATE, Chloride(221)

Standard: 1.0 mL of 0.020 N hydrochloric acid

Sample: 1.0 g

Acceptance criteria: NMT 0.07%

4.2 CHLORIDE AND SULFATE, Sulfate (221)

Standard: 1.0 mL of 0.020 N sulfuric acid

Sample: 2.0 g

Acceptance criteria: NMT 0.05%

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.

5 SPECIFIC TESTS

5.1 pH 〈791〉

Sample solution: 100 mg/mL

Acceptance criteria: 6.0–8.0

5.2 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.]

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

6 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〉

USP Calcium Gluceptate RS