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.
581, Chemical Method.
Acceptance criteria:
100.0%–120.0%
PERFORMANCE TESTS
• Disintegration 701
701
Time:
30 min
• Uniformity of Dosage Units 905:
Meet the requirements
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.
• USP Reference Standards 11
11
USP Ergocalciferol RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova
Scientific Liaison 1-301-816-8328 |
(DS2010) Monographs - Dietary Supplements |
| 701 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3065