Valerian Tablets
»Valerian Tablets contain Powdered Valerian Extract and contain not less than 90.0percent and not more than 120.0percent 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 100mg of Powdered Valerian Extract.
Identification—
A: Thin-Layer Chromatographic Identification Test á201ñ—
Adsorbent,Standard solution,Developing solvent system,and Procedure— Proceed as directed under Powdered Valerian Extract.
Test solution— Weigh and finely powder not fewer than 10Tablets.Transfer a portion of the powder,equivalent to about 100mg of Powdered Valerian Extract,to a suitable flask.Add 5mLof water and 3mLof a 10%aqueous solution of potassium hydroxide,extract this mixture with two 5-mLportions of methylene chloride,and discard the organic phase.Heat the aqueous phase on a water bath at 40for 10minutes,cool,acidify with 7%hydrochloric acid,and extract this solution with two 5-mLportions of methylene chloride.Dry the organic phase over anhydrous sodium sulfate,filter,evaporate the filtrate to dryness,and dissolve the residue in 1.0mLof methylene chloride.Apply 20µLto the plate in a 2-cm band.
B: The retention time of valerenic acid in the chromatogram of the Test solutioncorresponds to that in the chromatogram of the Standard solution,as obtained in the test for Content of valerenic acid.
Microbial enumeration á2021ñ— It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.The total aerobic microbial count does not exceed 10,000cfu per g,and the total combined molds and yeasts count does not exceed 1000cfu per g.
Disintegration and dissolution á2040ñ: meet the requirements for Disintegrationwith respect to botanical dosage forms.
Weight variation á2091ñ: meet the requirements.
Content of valerenic acid—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the test for Content of valerenic acidunder Powdered Valerian Extract.To evaluate the system suitability requirements,use the Standard preparation.
Standard solution— Dissolve an accurately weighed quantity of USP Valerenic Acid RSin methanol,and dilute quantitatively,and stepwise if necessary,with methanol to obtain a solution having a known concentration of about 3.5µg per mL.
Test solution— Weigh accurately not fewer than 20Tablets,and pulverize with a mortar and pestle.Transfer an accurately weighed portion of the powder,equivalent to about 0.09mg of valerenic acid,to a suitable flask.Add 25.0mLof methanol,shake to disperse the powder,sonicate for 10minutes,and centrifuge.Use the clear supernatant.
Procedure— Separately inject equal volumes (about 20µL)of the Standard solutionand the Test solutioninto 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 Cis the concentration,in mg per mL,of USP Valerenic Acid RSin the Standard solution;and rUand rSare the peak responses obtained from the Test solutionand the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2135
Pharmacopeial Forum:Volume No.27(1)Page 1827
Phone Number:1-301-816-8343