Vitamin A Capsules
DEFINITION
Vitamin A Capsules contain NLT 95.0% and NMT 120.0% of the labeled amount of vitamin A.
IDENTIFICATION
•  A.
Sample solution: A solution containing the equivalent of 6 µg/mL of retinol from Capsules in chloroform
Analysis: To 1 mL of Sample solution add 10 mL of antimony trichloride TS.
Acceptance criteria: A transient blue color appears at once.
•  B. Thin-Layer Chromatographic Identification Test
Standard solution: A solution containing the equivalent of 0.5 mg/mL of retinol from USP Vitamin A RS in chloroform
Sample solution: Dissolve or extract with chloroform a quantity of Capsules content to obtain a solution with a nominal concentration of 0.5 mg/mL of retinol.
Chromatographic system 
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture
Application volume: 10 µL
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. The approximate RF values of the predominant spots, corresponding to the different forms of retinol, are 0.1 for the alcohol form, 0.45 for the acetate, and 0.7 for the palmitate.
ASSAY
•  Content of Vitamin A
Analysis: Using NLT 5 Capsules, proceed as directed in Vitamin A Assay 571.
Calculate the content in mg of retinol (C20H30O) and in USP Vitamin A Units per Capsule. Calculate the percentage of the labeled amount of vitamin A as retinol in the Capsules.
Acceptance criteria: 95.0%–120%
PERFORMANCE TESTS
•  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 having a pH of 4.5 ± 0.05.
Temperature: 37 ± 2
Time: 45 min
Acceptance criteria: Meet the requirements
•  Uniformity of Dosage Units 905: Meet the requirements
SPECIFIC TESTS
•  Absorbance Ratio: The ratio of the corrected absorbance [A325] to the observed absorbance [A325], determined as directed in Vitamin A Assay 571, is NLT 0.85.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight, light-resistant containers.
•  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 mg. The vitamin A activity may be stated also in USP Units per Capsule, on the basis that 1 USP Vitamin A Unit equals the biological activity of 0.3 µg of the all-trans isomer of retinol.
•  USP Reference Standards 11
USP Vitamin A RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/QuestionContactExpert Committee
MonographNatalia Davydova
Scientific Liaison
1-301-816-8328
(DS2010) Monographs - Dietary Supplements
701Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106
(GCDF2010) General Chapters - Dosage Forms
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USP35–NF30 Page 5029