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Valerian Tablets
» Valerian Tablets contain Powdered Valerian Extract and contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of Powdered Valerian Extract, calculated as valerenic acid (C15H22O2).
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— The label states the Latin binomial and, following the official name, the article from which the Tablets were prepared. The label also indicates the quantity, in mg, of Powdered Valerian Extract per Tablet and the content, in mg, of valerenic acid per 100 mg of Powdered Valerian Extract.
A: Thin-Layer Chromatographic Identification Test 201
Adsorbent, Standard solution, Developing solvent system, and Procedure— Proceed as directed under Powdered Valerian Extract.
Test solution— Weigh and finely powder not fewer than 10 Tablets. Transfer a portion of the powder, equivalent to about 100 mg of Powdered Valerian Extract, to a suitable flask. Add 5 mL of water and 3 mL of a 10% aqueous solution of potassium hydroxide, extract this mixture with two 5-mL portions of methylene chloride, and discard the organic phase. Heat the aqueous phase on a water bath at 40 for 10 minutes, cool, acidify with 7% hydrochloric acid, and extract this solution with two 5-mL portions of methylene chloride. Dry the organic phase over anhydrous sodium sulfate, filter, evaporate the filtrate to dryness, and dissolve the residue in 1.0 mL of methylene chloride. Apply 20 µL to the plate in a 2-cm band.
B: The retention time of valerenic acid in the chromatogram of the Test solution corresponds to that in the chromatogram of the Standard solution, as obtained in the test for Content of valerenic acid.
Microbial enumeration 2021 It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. The total aerobic microbial count does not exceed 10,000 cfu per g, and the total combined molds and yeasts count does not exceed 1000 cfu per g.
Disintegration and dissolution 2040: meet the requirements for Disintegration with respect to botanical dosage forms.
Weight variation 2091: meet the requirements.
Content of valerenic acid—
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the test for Content of valerenic acid under Powdered Valerian Extract. To evaluate the system suitability requirements, use the Standard preparation.
Standard solution— Dissolve an accurately weighed quantity of USP Valerenic Acid RS in methanol, and dilute quantitatively, and stepwise if necessary, with methanol to obtain a solution having a known concentration of about 3.5 µg per mL.
Test solution— Weigh accurately not fewer than 20 Tablets, and pulverize with a mortar and pestle. Transfer an accurately weighed portion of the powder, equivalent to about 0.09 mg of valerenic acid, to a suitable flask. Add 25.0 mL of methanol, shake to disperse the powder, sonicate for 10 minutes, and centrifuge. Use the clear supernatant.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the responses for the valerenic acid peaks. Calculate the quantity, in mg, of valerenic acid (C15H22O2) in the portion of Tablets taken by the formula:
25C(rU / rS),
in which C is the concentration, in mg per mL, of USP Valerenic Acid RS in the Standard solution; and rU and rS are the peak responses obtained from the Test solution and the Standard solution, respectively.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 2386
Pharmacopeial Forum : Volume No. 27(1) Page 1827
Phone Number : 1-301-816-8318