Sennosides Tablets
»Sennosides Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of Sennosides.
Packaging and storage
Preserve in well-closed containers.
Identification
Aportion of finely powdered Tablets,equivalent to about 20mg of sennosides,responds to the Identificationtest under Sennosides.
Dissolution á711ñ
Medium:
water;900mL.
Apparatus 1:
100rpm.
Time:
120minutes.
Procedure
Determine the amount of sennosides dissolved,employing the procedure set forth in the Assay,making any necessary volumetric adjustments.
Tolerances
Not less than 75%(Q)of the labeled amount of sennosides is dissolved in 120minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay
pH7.0phosphate buffer,Borate solution,Sodium dithionite solution,and Standard preparation
Prepare as directed in the Assayunder Sennosides.
Assay preparation
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 25mg of sennosides,to a 25-mLvolumetric flask.Add 20mLof pH7.0phosphate buffer,sonicate to dissolve the sennosides,add pH7.0phosphate bufferto volume,and mix.Centrifuge the resulting suspension for 15minutes at 3500rpm.The supernatant is the Assay preparation.
Procedure
Proceed as directed for Procedurein the Assayunder Sennosides.Calculate the quantity,in mg,of sennosides in the portion of Tablets taken by the formula:
25C(IU/IS),
in which Cis the concentration,in mg per mL,of USP Sennosides RS,corrected for loss on drying,in the Standard preparation,and IUand ISare the fluorescence values observed for the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information
Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28NF23Page 1766
Phone Number:1-301-816-8343
|