Ergocalciferol Tablets
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
USP Ergocalciferol RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Natalia Davydova
Scientific Liaison
(DS2010) Monographs - Dietary Supplements
701 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
(GCDF2010) General Chapters - Dosage Forms
Reference Standards RS Technical Services
USP35–NF30 Page 3065