Ergocalciferol 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

Ergocalciferol Tablets contain NLT 100.0% and NMT 120.0% of the labeled amount of ergocalciferol (C₂₈H₄₄O).

2 IDENTIFICATION

Change to read:

A. ULTRAVIOLET ABSORPTION: The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay _{(USP 1-Aug-2024)}

Delete the following:

B. COLOR REACTION _{(USP 1-A-2024)}

Add the following:

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay _{(USP 1-Aug-2024)}

3 ASSAY

Change to read:

PROCEDURE

[NOTE-Use low-actinic glassware.]

Diluent: Water, dimethylformamide, and isopropyl alcohol (5:10:35)

Mobile phase: Acetonitrile and water (70:30)

Standard stock solution: 0.5 mg/mL of USP Ergocalciferol RS in isopropyl alcohol

Cholecalciferol stock solution: 0.5 mg/mL of USP Cholecalciferol RS in isopropyl alcohol

System suitability solution: Combine equal volumes of the Standard stock solution and Cholecalciferol stock solution and dilute with Diluent to obtain a concentration of about 1 µg/mL each of cholecalciferol and ergocalciferol.

Standard solution: 1 µg/mL of USP Ergocalciferol RS from the Standard stock solution in Diluent. Dilute stepwise, if necessary.

Sample solution: Finely powder NLT 20 Tablets. Transfer a portion of the powder, nominally equivalent to 50 µg of ergocalciferol, into a 50-mL volumetric flask, add 5 mL of water, and sonicate for 10 min with intermittent shaking. Add 10 mL of dimethylformamide, sonicate for 15 min with intermittent shaking, cool to room temperature, and dilute with isopropyl alcohol to volume. Mix well and pass through a membrane filter of 0.45-um or finer pore size.

Chromatographic system

(See Chromatography (621). System Suitability.)

Mode: LC

Detector: UV 265 nm

Column: 4.6-mm x 15-cm; 2.7-µm packing 196

Column temperature: 40°

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Samples: System suitability solution and Standard solution

[NOTE-The relative retention times for cholecalciferol and ergocalciferol are 0.9 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 1.5 between the cholecalciferol and ergocalciferol peaks, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of ergocalciferol (C₂₈H₄₄O) in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak area of ergocalciferol from the Sample solution

r_s = peak area of ergocalciferol from the Standard solution

C_s = concentration of ergocalciferol in the Standard solution (µg/mL)

C_u = nominal concentration of ergocalciferol in the Sample solution (µg/mL)

_{(USP 1-Aug-2024)}

Acceptance criteria: 100.0%–120.0%

4 PERFORMANCE TESTS

DISINTEGRATION (701)

Time: 30 min.

Acceptance criteria: Meet the requirements

UNIFORMITY OF DOSAGE UNITS (905): Meet the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.

Change to read:

LABELING: Label the Tablets to indicate the content of ergocalciferol, in micrograms. Expression of the amount of ergocalciferol in terms of units may be added in parentheses after the mass units. ¹ _{(USP 1-Aug-2024)}

Change to read:

USP REFERENCE STANDARDS (11)

USP Cholecalciferol RS (USP 1-Aug-2024)

USP Ergocalciferol RS

¹ Where articles are labeled in terms of units in addition to the required labeling, the relationship of the USP Units or International Units (IU) to mass is as follows: 1 µg of cholecalciferol or ergocalciferol = 40 USP Units or IU.