Racemic Calcium Pantothenate

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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C₁₈H₃₂CaN₂O₁₀ 476.53

β-Alanine, N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-, calcium salt (2:1), (±)-;

Calcium dl-pantothenate (1:2) CAS RN^®: 6381-63-1; UNII: 2KC899R47Q.

1 DEFINITION

Racemic Calcium Pantothenate is a mixture of the calcium salts of the dextrorotatory and levorotatory isomers of pantothenic acid. It contains NLT 5.7% and NMT 6.0% of nitrogen (N), and NLT 8.2% and NMT 8.6% of calcium (Ca), both calculated on the dried basis.

[Note-The physiological activity of Racemic Calcium Pantothenate is approximately one-half that of Calcium Pantothenate.]

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

B. Identification Tests-General, Calcium 〈191〉: A 50-mg/mL solution meets the requirements.

3 COMPOSITION

3.1 Nitrogen Determination, Method I 〈461〉

Sample: 500 mg

Analysis: Proceed as directed in the chapter.

Acceptance criteria: 5.7%–6.0% on the dried basis

3.2 Content of Calcium

Sample: 800 mg

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 in 150 mL of water containing 2 mL of 3 N hydrochloric acid. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and titrate with the Titrant to a distinct blue endpoint. Perform the Blank determination.

Calculate the percentage of calcium (Ca) in the Sample taken:

Result = {[(V_S − V_B) × M × F]/W} × 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, 40.08 mg/mM

W = Sample weight (mg)

Acceptance criteria: 8.2%–8.6% on the dried basis

4 SPECIFIC TESTS

4.1 Optical Rotation, Specific Rotation 〈781S〉

Test solution: 50 mg/mL in water

Acceptance criteria: −0.05° to +0.05°

4.2 Alkalinity

Sample: 1.0 g

Analysis: Dissolve the Sample in 15 mL of carbon dioxide-free water in a small ￾ask. As soon as the solution is complete, add 1.6 mL of 0.10 N hydrochloric acid, and then add 0.05 mL of phenolphthalein TS.

Acceptance criteria: No pink color is produced within 5 s.

4.3 Loss on Drying 〈731〉

Dry a sample at 105° for 3 h: it loses NMT 5.0% of its weight.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

Labeling: Label preparations containing it in terms of the equivalent amount of dextrorotatory calcium pantothenate.

USP Reference Standards 〈11〉

USP Calcium Pantothenate RS