Ergocalciferol Tablets contain NLT 100.0% and NMT 120.0% of the labeled amount of ergocalciferol (C28H44O).
• A. Ultraviolet Absorption
Standard solution: 0.01 mg/mL of USP Ergocalciferol RS in alcohol
Sample solution: Evaporate 1 mL of the Sample solution obtained from Identification test B under a stream of nitrogen to dryness. Dissolve the residue in 50 mL of alcohol.
Samples: Standard solution and Sample solution
Acceptance criteria: The absorption spectrum of the Sample solution exhibits maxima and minima at the same wavelengths as that of the Standard solution, concomitantly measured.
• B. Color Reaction
Sample solution: Triturate a quantity of powdered Tablets, equivalent to 5 mg of ergocalciferol, with 10 mL of chloroform, and filter.
Analysis: To 5 mL of the Sample solution add 0.3 mL of acetic anhydride and 0.1 mL of sulfuric acid, and shake vigorously.
Acceptance criteria: A bright red color is produced and rapidly changes through violet and blue to green.
• Procedure: Proceed with Tablets as directed in Vitamin D Assay 581, Chemical Method.
Acceptance criteria: 100.0%120.0%
• Disintegration 701
Time: 30 min
• Uniformity of Dosage Units 905: Meet the requirements
• Packaging and Storage: Preserve in tight, light-resistant containers.
• Labeling: Label the Tablets to indicate the content of ergocalciferol, in mg. The activity may be expressed also in terms of USP Units, on the basis that 40 USP Vitamin D Units = 1 µg.
• USP Reference Standards 11
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USP35NF30 Page 3065