Vitamin A Capsules

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

Vitamin A Capsules contain NLT 95.0% and NMT 120.0% of the labeled amount of vitamin A.

2 IDENTIFICATION

2.1 A.

Sample solution: Equivalent to 6 µg/mL of Retinol from Capsules in methylene chloride

Analysis: To 1 mL of Sample solution add 10 ml of antimony trichloride TS.

Acceptance criteria: A transient blue color appears at once.

Change to read:

2.2 B. THIN-LAYER CHROMATOGRAPHY

Standard solution: 0.5 mg/mL of retinol from USP Retinyl Acetate RS or USP Retinyl Palmitate RS in methylene chloride

Sample solution: Dissolve or extract with methylene chloride the contents of a quantity of Capsules to obtain a solution with a nominal concentration of 0.5 mg/mL of retinol.

Chromatographic system

(See Chromatography (621), General Procedures, Thin-Layer Chromatography.)

Adsorbent: 0.25-mm layer of chromatographic silica gel mixture

Application volume: 10 µL, ^▲8-mm band _{▲(USP 1-Aug-2019)}

Developing solvent system: Cyclohexane and ether (4:1)

Spray reagent: Phosphomolybdic acid TS

Analysis: Proceed as directed in the chapter, using the Developing solvent system. Locate the spots on the plate using the Spray reagent.

Acceptance criteria: The blue-green spot formed is indicative of the presence of retinol, and its R, value corresponds to that of the Standard solution. (The approximate R values of the predominant spots, corresponding to the different forms of retinol, are 0.1 for the alcohol form, 0.45 for the acetate form, and 0.7 for the palmitate form.)

3 ASSAY

VITAMIN A ASSAY (571)

Analysis: Use the appropriate procedure described in Vitamin A Assay (571), Assay. Chromatographic Methods. [NOTE-The procedure used is stated in the labeling only if Procedure 1 is not used.]

Acceptance criteria: 95.0%-120.0%

4 PERFORMANCE TESTS

4.1 DISINTEGRATION (701)

Immersion fluid: Use 0.05 M acetate buffer, prepared by mixing 2.99 g of sodium acetate and 1.66 mL of glacial acetic acid with water to obtain 1000 mL of solution with a pH of 4.5 ± 0.05.

Temperature: 37 ± 2°

Time: 45 min

Acceptance criteria: Meet the requirements

4.2 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 Capsules to indicate the form in which the vitamin is present, and to indicate the vitamin A activity in terms of the equivalent amount of retinol in ^▲µg/Capsule. Expression of the amount of vitamin A in terms of units may be added in parentheses after the mass units._{▲(USP 1-Aug-2019)}

USP REFERENCE STANDARDS (11)

USP Retinyl Acetate RS

USP Retinyl Palmitate RS