Ginger
»Ginger is the rhizome of Zingiber officinaleRoscoe (Fam.Zingiberaceae),scraped or unscraped.It is known in commerce as unbleached ginger.
Packaging and storage— Preserve in well-closed containers,protected from light and moisture.
Labeling— The label states the Latin binominal name and,following the official name,the part of the plant contained in the article.
Botanic characteristics—
Macroscopic— Ginger occurs in horizontal,laterally flattened,sympodially branching pieces.Whole rhizomes are 5to 15cm long,1.5to 6cm wide,and up to 2cm thick,sometimes split longitudinally;pale yellowish buff or light brown externally,longitudinally striated,somewhat fibrous;branches flattish,obovate,short,about 2cm long,each ending with a depressed stem scar;fracture,short with projecting fibers,or sometimes resinous;internally yellowish brown,showing a yellow endodermis separating the narrow cortex from the wide stele,and numerous yellowish points,secretion cells and numerous bigger greyish points,vascular bundles,scattered on the whole surface.The unscraped rhizome shows in addition an outer layer of dark brown cork.
Histology: Starch abundant in the thin-walled ground tissue,as flattened,ovate to subrectangular,transversely striated,simple granules,each with the hilum in a projection toward one end,mostly up to about 50µm long and up to about 25µm wide and 7µm thick.Oleoresin cells,with suberised cell walls and yellow contents,numerous in the ground tissue—pigment cells with dark,reddish brown contents occurring either singly in the ground tissue or in axial rows accompanying the vascular bundles.Irregularly shaped,thin-walled fibers with delicate transverse septa,yielding only slightly the reaction characteristic of lignin.Vessels with spiral or reticulate thickening in the scattered vascular bundles not yielding the reaction characteristic of lignin.In the unscraped ginger,varying amounts of cork,composed of thin-walled cells.Sclereids and calcium oxalate crystals absent.
Identification—
A: Pulverize about 5g of Ginger.To about 1g of the pulverized Ginger add 5mLof dilute acetic acid,prepared by diluting 1part of glacial acetic acid with 1part of water,and shake for 15minutes.Filter,and add a few drops of ammonium oxalate TSto the filtrate:not more than a slight turbidity is produced.
B: Dissolve about 50mg of the residue obtained in the test for Alcohol-soluble extractivesin 25mLof water,and extract this solution with two 15-mLportions of ether.Combine the ether extracts,and evaporate in a porcelain dish.To the residue so obtained,add 5mLof sulfuric acid solution (7.5in 10.0)and about 5mg of vanillin.Allow to stand for 15minutes,and add an equal volume of water:the solution turns azure blue.
C: Thin-Layer Chromatographic Identification Test á201ñ
Adsorbent: 0.50-mm layer of chromatographic silica gel mixture.
Test solution— Pulverize about 5g of Ginger.Transfer about 0.2g of pulverized sample to a test tube,add 5mLof methanol,shake for 30minutes,and centrifuge.Apply the supernatant to the plate.
Standard solution— Proceed as directed for the Test solution,except to use 0.2g of USP Powdered Ginger RS.
Application volume: 20µL.
Developing solvent system: a mixture of ether and hexanes (7:3).
Procedure— Proceed as directed in the chapter.Aspot due to gingerols occurs at an RFvalue of about 0.2and a spot of shogaols may occur at an RFvalue of about 0.4.[NOTE—The chromatograms of the Test solutionand the Standard solutionmay exhibit other spots in the upper region and at the origin of the plate.]
Microbial enumeration á2021ñ The total bacterial count does not exceed 10,000cfu per g.The total combined molds and yeasts count does not exceed 100cfu per g,and it meets the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,and Staphylococcus aureus.
Total ash á561ñ: not more than 8.0%.
Acid-insoluble ash á561ñ: not more than 2.0%.
Water-soluble ash á561ñ: not less than 1.9%.
Water,Method Ia á921ñ: not more than 10%.
Alcohol-soluble extractives,Method 2á561ñ Evaporate the filtrate at a temperature not exceeding 90:not less than 4.5%is found.Save the residue for use in Identificationtest Band the tests for Content of gingerols and gingerdionesand Limit of shogaols.
Foreign organic matter á561ñ: not more than 1.0%.
Volatile oil content á561ñ: not less than 1.8mLper 100g.
Pesticide residues á561ñ: meets the requirements.
Content of starch,Method 1á561ñ: not less than 42%,Method Iaof the General Proceduresbeing used.
Limit of shogaols— From the chromatograms obtained in the test for Content of gingerols and gingerdiones,calculate the sum of the peak responses due to shogaols,occurring at about the following retention times,relative to 1.0for capsaicin:1.86for 6-shogaol,4.22for 8-shogaol and 5.76for 10-shogaol.Calculate the percentage of shogaols,B,in the portion of the residue from the test for Alcohol-soluble extractivestaken for the Test preparationin the test for Content of gingerols and gingerdionesby the formula:
1000(C/W)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Capsaicin RSin the Standard preparation;Wis the weight,in mg,of the residue from the test for Alcohol-soluble extractivestaken for the Test preparation;rUis the sum of the peak responses due to shogaols as calculated above;and rSis the peak response due to capsaicin obtained from the Standard preparation:not more than 4.0%is found.Calculate the percentage of shogaols in the Ginger rhizome by the formula:
EB/100,
in which Eis the percentage of alcohol-soluble extractive found in the test for Alcohol-soluble extactives;and Bis as defined above:not more than 0.18%of shogaols is found.
Content of gingerols and gingerdiones—
Mobile phase— Prepare a filtered and degassed mixture of acetonitrile,dilute phosphoric acid (1in 1000),and methanol (55:44:1).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Dissolve an accurately weighed quantity of USP Capsaicin RSin methanol to obtain a solution having a known concentration of about 0.25mg per mL.
Test preparation— Transfer about 50mg,accurately weighed,of the residue (equivalent to about 9mg of gingerols)retained from the test for Alcohol-soluble extractivesto a 10-mLvolumetric flask,dissolve in and dilute with methanol to volume,and mix.
System suitability solution— Mix 1.0mLof the Standard preparationwith 1.0mLof the Test preparation.
Chromatographic system (see Chromatography á621ñ) The liquid chromatograph is equipped with a 282-nm detector and a 4.6-mm ×25-cm column that contains packing L1.The flow rate is about 1.0mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative standard deviation for replicate injections is not more than 2.5%.Chromatograph the System suitability solution,and record the peak responses as directed for Procedure:the relative retention times are about 0.8for 6-gingerol,1.0for capsaicin,1.51for 8-gingerol A,2.21for 8-gingerol B,2.46for 6-gingerdiol,2.60for 6-gingerdione,3.35for 10-gingerol,and 5.16for 8-gingerdione;and the resolution,R,between 6-gingerol and capsaicin is not less than 1.0.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Test preparationinto the chromatograph,and allow the Test preparationto elute for not less than seven times the retention time of capsaicin.Record the chromatograms,and measure all of the peak responses.Calculate the percentage of gingerols and gingerdiones,A,in the portion of the residue from the test for Alcohol-soluble extractivestaken for the Test preparationby the formula:
1000(C/W)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Capsaicin RSin the Standard preparation;Wis the weight,in mg,of the residue from the test for Alcohol-soluble extractivestaken for the Test preparation;rUis the sum of the peak responses due to gingerols and gingerdiones as calculated above;and rSis the capsaicin peak response obtained from the Standard preparation:not less than 18%of gingerols and gingerdiones is found.Calculate the percentage of gingerols and gingerdiones in the Ginger rhizome by the formula:
EA/100,
in which Eis the percentage of alcohol-soluble extractives obtained in the test for Alcohol-soluble extractives;and Ais as defined above:not less than 0.8%is found.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2091
Pharmacopeial Forum:Volume No.26(6)Page 1600
Phone Number:1-301-816-8343