Calcium Succinate

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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C₄H₄CaO₄.H₂O     174.17

Butanedioic acid, calcium salt (1:1), monohydrate;

Calcium succinate monohydrate CAS RN: 159389-75-0; UNII: 158D828FC0.

Anhydrous CAS RN: 140-99-8; UNII: P455B96DTZ.

1 DEFINITION

Calcium Succinate contains NLT 98.0% and NMT 102.0% of calcium succinate (C₄H₄CaO₄.H₂O ), calculated on the dried basis.

2 IDENTIFICATION

A. IDENTIFICATION TESTS GENERAL, Calcium (191)

Sample solution: 20 mg/mL

Acceptance criteria: Meets the requirements

Change to read:

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

3 ASSAY

PROCEDURE

Sample: 650 mg of Calcium Succinate

Titrimetric system

(See Titrimetry (541).)

Mode: Direct titration

Titrant: 0.1 M edetate disodium VS

Endpoint detection: Visual

Analysis: Transfer the Sample into a 250-mL beaker, add 100 mL of water and 2 mL of concentrated hydrochloric acid, and stir using a magnetic stirring bar. While stirring, add 30 mL of Titrant from the titration buret, and 25 mL of 2 N sodium hydroxide. Check the pH of the solution and make sure it is between 12.0 and 13.0. Add 300-500 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Perform a blank determination.

Calculate the percentage of calcium succinate (C₄H₄CaO₄.H₂O ) 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 (mmol/mL)

F = equivalency factor, 156.15 mg/mmol

W = Sample weight (mg)

Acceptance criteria: 98.0%-102.0% on the dried basis

4 IMPURITIES

4.1 CHLORIDE AND SULFATE, Chloride(221)

Standard solution: 1.0 mL of 0.010 N hydrochloric acid

Sample: 1.8 g

Acceptance criteria: NMT 0.02%

4.2 CHLORIDE AND SULFATE, Sulfate (221)

Standard solution: 1.0 mL of 0.020 N sulfuric acid

Sample: 2.0 g

Acceptance criteria: NMT 0.05%

Elemental Impurities—Procedures 〈233〉

Acceptance criteria

Arsenic: NMT 3.0 μg/g

Cadmium: NMT 2.0 μg/g

Lead: NMT 2.0 μg/g

Mercury: NMT 0.1 μg/g

5 SPECIFIC TESTS

5.1 pH 〈791〉

Sample solution: 50 mg/mL in water. [Note—The solution is slurry.]

Acceptance criteria: 7.0–12.0

5.2 Loss on Drying 〈731〉

Analysis: Dry at 160° for 5 h.

Acceptance criteria: 9.0%–13.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Calcium Succinate RS