Add the following:
Ginger Capsules
»Ginger Capsules are prepared from Powdered Ginger and contain not less than 90.0percent and not more than 110.0percent of the labeled amount of gingerols,gingerdiones,and shogaols,and not less than 90.0percent of the labeled amount of volatile oil.
Packaging and storage— Preserve in well-closed containers,and store at controlled room temperature.
Labeling— The label states the Latin binomial and,following the official name,the part of the plant from which the article was prepared.The label also indicates the content of gingerols,gingerdiones,and shogaols,in mg per Capsule,and the content of volatile oil,in µLper Capsule.
Identification: meet the requirements ofIdentification testsA,B,andCunderGinger.
Dissolution á2040ñ—
Medium: 0.1Nhydrochloric acid;500mL.
Apparatus 2: 75rpm.
Time: 60minutes.
NOTE—In each dissolution vessel,place a number of Capsules equivalent to about 20mg of the labeled amounts of gingerols,gingerdiones,and shogaols.
Mobile phase— Prepare as directed in the test forContent of gingerols and gingerdiones underGinger.
Standard stock solution— Use theStandard preparation,prepared as directed in the test forContent of gingerols and gingerdiones underGinger.
Standard solution— Transfer 1.0mLof theStandard stock solution to a 10-mLvolumetric flask,and dilute withMedium to volume to obtain a solution having a known concentration of about 0.025mg of USP Capsaicin RSper mL.
Test solution— Transfer an aliquot of solution from each dissolution vial to a suitable vial.Allow to stand for 5minutes so the powder settles into the suspension,or centrifuge to obtain a clear supernatant.Pass through a membrane filter having a 0.45-µm or finer porosity.
Chromatographic system— Proceed as directed in the test forContent of gingerols and gingerdiones underGinger.To evaluate the system suitability requirements,use theStandard preparation and theSystem suitability solution,prepared as directed in the test forContent of gingerols and gingerdiones underGinger.
Procedure— Separately inject equal volumes (about 20µL)of theStandard solution and theTest solution into the chromatograph,and allow theTest solution to elute for not less than three times the retention time of capsaicin.Record the chromatograms,and measure all of the peak responses.Calculate the quantity,in mg,of 6-gingerol dissolved,G,from each Capsule taken by the formula:
500(C/N)(rU/rS),
in whichCis the concentration,in mg per mL,of USP Capsaicin RSin theStandard solution;Nis the number of Capsules in each vessel;rUis the peak response for 6-gingerol obtained from theTest solution;and rSis the peak response for capsaicin obtained from theStandard solution.Calculate the percentage of the relative amount of 6-gingerol dissolved by the formula:
100(G/G0),
in which G0is the content of 6-gingerol,in mg,in each Capsule,as determined in the test forContent of gingerols,gingerdiones,and shogaols.
Tolerances— Not less than 60%of the content of 6-gingerol (C17H26O4)is dissolved in 60minutes.
Weight variation á2091ñ: meet the requirements.
Volatile oil content á561ñ— Weigh and finely powder a quantity of Capsules,equivalent to about 100g of powdered ginger:not less than 1.4mLper 100g is found.
Content of gingerols,gingerdiones,and shogaols—
Mobile phase,Standard preparation,System suitability solution,and Chromatographic system— Proceed as directed in the test forContent of gingerols and gingerdiones underGinger.
Test preparation— Carefully open not fewer than 20Capsules,and transfer about 1.0g of the powder,accurately weighed,to a glass-stoppered conical flask.Add 50mLof alcohol,insert a stopper into the flask,and macerate for 24hours,shaking frequently during the first 8hours,and then allowing to stand for 18hours.Filter,and evaporate the solvent to dryness in a vacuum.Quantitatively transfer the contents with the aid of methanol to a 10-mLvolumetric flask,add methanol to volume,and mix.
Procedure— Proceed as directed in the test forContent of gingerols and gingerdiones underGinger.Calculate the amounts,in mg,of gingerols,gingerdiones,and shogaols in the portion of the Capsules taken by the formula:
10C(rU/rS),
in whichCis the concentration,in mg per mL,of USP Capsaicin RSin theStandard preparation;rUis the sum of peak responses for gingerols,gingerdiones,and shogaols;and rSis the peak response for capsaicin obtained from theStandard preparation.Calculate the amount,in mg,of 6-gingerol in the portion of Capsules taken by the formula:
10C(rU/rS),
in which rUis the peak response for 6-gingerol obtained from theTest preparation;and the other terms are as defined above.USP28
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2093
Pharmacopeial Forum:Volume No.28(3)Page 814
Phone Number:1-301-816-8343