Dihydrotachysterol Oral Solution
» Dihydrotachysterol Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of dihydrotachysterol (C28H46O).
Packaging and storage— Preserve in tight, light-resistant glass containers.
USP Reference standards 11
USP Dihydrotachysterol RS Click to View Structure
A: Place 1 drop of Oral Solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel. Spray the plate with 3.5% phosphomolybdic acid solution (prepared by dissolving 3.5 g of phosphomolybdic acid in 100 mL of isopropyl alcohol), and immediately heat the plate over a hot plate: a dark blue spot appears on a yellow background.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Uniformity of dosage units 905
for oral solution packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral solution packaged in multiple-unit containers:
meets the requirements.
Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system— Prepare as directed in the Assay under Dihydrotachysterol.
Assay preparation [for oral solution in an oil medium]—Transfer an accurately measured volume of Oral Solution, equivalent to about 500 µg of dihydrotachysterol, by means of a “to contain” pipet to a 50-mL volumetric flask. Rinse the pipet with Mobile phase, add the rinsing to the flask, dilute with Mobile phase to volume, and mix.
Assay preparation [for oral solution in an aqueous medium]— Transfer an accurately measured volume of Oral Solution, equivalent to about 600 µg of dihydrotachysterol, to a separator containing about 30 mL of water. Add about 1 g of sodium chloride, mix, and extract with three 15-mL portions of chloroform, filtering each portion through absorbent cotton into a suitable glass-stoppered conical flask. Wash the cotton with about 5 mL of chloroform, collecting the washing in the glass-stoppered conical flask. Evaporate the chloroform extracts, and wash with the aid of a current of air to dryness. Dissolve the residue in 50.0 mL of Mobile phase, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Dihydrotachysterol. Calculate the quantity, in µg, of dihydrotachysterol (C28H46O) in the volume of Oral Solution taken by the formula:
50C(rU / rS)
in which C is the concentration, in µg per mL, of USP Dihydrotachysterol RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Principal Scientific Liaison
(SM32010) Monographs - Small Molecules 3
Reference Standards RS Technical Services
USP35–NF30 Page 2911
Pharmacopeial Forum: Volume No. 29(6) Page 1873