Ergocalciferol Tablets DEFINITION Ergocalciferol Tablets contain NLT 100.0% and NMT 120.0% of the labeled amount of ergocalciferol (C28H44O). IDENTIFICATION • 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. Analysis 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. ASSAY • Procedure: Proceed with Tablets as directed in Vitamin D Assay 581, Chemical Method. Acceptance criteria: 100.0%120.0% PERFORMANCE TESTS • Disintegration 701 Time: 30 min • Uniformity of Dosage Units 905: Meet the requirements ADDITIONAL 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. Auxiliary Information Please check for your question in the FAQs before contacting USP.
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