Calcium Pantothenate Tablets

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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1 DEFINITION

Calcium Pantothenate Tablets contain NLT 95.0% and NMT 115.0% of the labeled amount of the dextrorotatory isomer of calcium pantothenate (C₁₈H₃₂CaN₂O₁₀).

2 IDENTIFICATION

A. Identification Tests—General, Calcium 〈191〉

Sample solution: Digest a quantity of powdered Tablets, equivalent to 150 mg of calcium pantothenate, with 15 mL of 1 N sodium hydroxide, and filter.

Acceptance criteria: Meet the requirements

B.Sample solution: 5 mL of the filtrate obtained in Identification test A

Analysis: Add 5 mL of 1 N hydrochloric acid and 2 drops of ferric chloride TS to the Sample solution.

Acceptance criteria: A strong yellow color is produced.

3 ASSAY

Calcium Pantothenate

Buffer solution: Dissolve 10.0 g of monobasic potassium phosphate in 2000 mL of water, and adjust with phosphoric acid to a pH of 3.5.

Mobile phase: Methanol and Buffer solution (1:9)

System suitability solution: 0.5 mg/mL of USP Calcium Pantothenate RS and 0.1 mg/mL of USP Racemic Panthenol RS in water

Standard solution: 0.5 mg/mL of USP Calcium Pantothenate RS in water

Sample solution: Finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to 50 mg of calcium pantothenate, to a 100-mL volumetric flask. Add 5 mL of methanol, and swirl the flask to disperse. Dilute with water to volume, mix, and filter.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 205 nm

Column: 4.6-mm × 25-cm; 5-μm packing L1

Column temperature: 50°

Flow rate: 2 mL/min

Injection volume: 25 μL

System suitability

Sample: System suitability solution

[Note—The relative retention times for pantothenate and panthenol are 1.0 and 1.1, respectively.]

Suitability requirements

Resolution: NLT 1.5 between pantothenate and panthenol

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Measure the peak areas for calcium pantothenate.

Calculate the percentage of the labeled amount of calcium pantothenate (C₁₈H₃₂CaN₂O₁₀) in the portion of Tablets taken:

Result = (r_U /r_S) × (C_S /C_U ) × 100

r_U = peak area from the Sample solution

r_S = peak area from the Standard solution

C_S = concentration of USP Calcium Pantothenate RS in the Standard solution (mg/mL)

C_U = nominal concentration of calcium pantothenate in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–115.0%

4 OTHER COMPONENTS

Content of Calcium

Sample: A portion of the powder from NLT 20 finely powdered Tablets, equivalent to 500 mg of calcium pantothenate

Blank: Proceed as directed in the Analysis, without the Sample.

Titrimetric system

(See Titrimetry 〈541〉.)

Mode: Direct titration

Titrant: 0.05 M edetate disodium VS

Indicator: Hydroxy naphthol blue, 300 mg

Endpoint detection: Visual

Analysis: Transfer the Sample to a suitable crucible. Ignite, gently at first, until free from carbon. Cool the crucible. Add 10 mL of water, and dissolve the residue by adding sufficient 3 N hydrochloric acid, dropwise, to completely dissolve. Transfer the solution to a suitable container, and dilute with water to 150 mL. Add 15 mL of 1 N sodium hydroxide, then add the Indicator. Titrate with Titrant to a distinct blue endpoint. Perform a blank determination.

Calculate the percentage of calcium in the content of calcium pantothenate, as determined by the Assay, in the portion of Tablets 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 = weight of calcium pantothenate in the Sample taken, as determined by the Assay (mg)

Acceptance criteria: 7.9%–9.7% of the weight of calcium pantothenate (C₁₈H₃₂CaN₂O₁₀) in the Tablets, as determined by the Assay

5 PERFORMANCE TESTS

Dissolution, Procedure for a Pooled Sample 〈711〉

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Mobile phase: Phosphoric acid and water (1:1000)

Standard solution: A known concentration of USP Calcium Pantothenate RS in Medium

Sample solution: A ltered portion of the solution under test, suitably diluted with Medium if necessary, having a concentration of C₁₈H₃₂CaN₂O₁₀ similar to that of the Standard solution

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 3.9-mm × 15-cm; packing L1

Flow rate: 1.5 mL/min

Injection volume: 10 μL

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 3.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of calcium pantothenate (C₁₈H₃₂CaN₂O₁₀) dissolved:

Result = (r_U/r_S ) × [C_S × D × (V/L)] × 100

r_U = peak area of calcium pantothenate from the Sample solution

r_S = peak area of calcium pantothenate from the Standard solution

C_S = concentration of the Standard solution (mg/mL)

D = dilution factor for the Sample solution

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 75% (Q) of the labeled amount of calcium pantothenate (C₁₈H₃₂CaN₂O₁₀) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

Labeling: Label the Tablets to indicate the content of dextrorotatory calcium pantothenate.

USP Reference Standards 〈11〉

USP Calcium Pantothenate RS

USP Racemic Panthenol RS