Capsicum Oleoresin
»Capsicum Oleoresin is an alcoholic extract of the dried ripe fruits of Capsicum annumvar.minimumand small fruited varieties of C.fruiscons(Solanaceae).It contains not less than 8.0percent of total capsaicins [capsaicin (C18H27NO3),dihydrocapsaicin (C18H29NO3),and nordihydrocapsaicin (C17H27NO3)].
Caution—Capsicum Oleoresin is a powerful irritant,and even in minute quantities produces an intense burning sensation when it comes in contact with the eyes and tender parts of the skin.Care should be taken to protect the eyes and to prevent contact of the skin with Capsicum Oleoresin.
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate that if separation occurs,it should be warmed and mixed before use.
Identification— To about 0.5g of it in a beaker add 5mLof water and 10mLof a mixture of water,0.2Mpotassium chloride,and 0.2Nhydrochloric acid (135:50:13),and mix.Add 5.0mLof 0.5Msodium nitrite and 5.0mLof 0.02Msodium tungstate,and mix.Heat at 55to 60for 15minutes,allow to cool,and filter.To the filtrate add 10mLof 1Nsodium hydroxide:a bright yellow color is produced (presence of capsaicin).
Assay—
Mobile phase— Prepare a mixture of methanol and 2%acetic acid (56:44),filter through a 0.5-µm or finer porosity filter,and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Prepare a solution of USP Capsaicin RSin methanol having a known concentration of about 0.5mg per mL.Filter a portion of this solution through a 0.2-µm porosity filter,and use the filtrate as the Standard preparation.
Assay preparation— Transfer about 1000mg of Capsicum Oleoresin,accurately weighed,to a 100-mLvolumetric flask,dissolve in and dilute with methanol to volume,and mix.Filter a portion of this solution through a 0.2-µm porosity filter,and use the filtrate as the Assay preparation.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 280-nm detector and a 3.9-mm ×30-cm column that contains packing L1.The flow rate is about 2mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the tailing factor is not more than 2.0,and the relative standard deviation for replicate injections is not more than 2.0%.Chromatograph the Assay preparation,and record the peak responses as directed for Procedure:the relative retention times are about 0.9for nordihydrocapsaicin,1.0for capsaicin,and 1.6for dihydrocapsaicin,and the resolution,R,between the nordihydrocapsaicin peak and the capsaicin peak is not less than 1.2.
Procedure— [NOTE—Use peak areas where peak responses are indicated.]Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the three major peaks.Calculate the percentage of total capsaicins in the portion of Capsicum Oleoresin taken by the formula:
(CP/W)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Capsaicin RSin the Standard preparation,Pis the designated purity,in percentage,of USP Capsaicin RS,Wis the weight,in mg,of Capsicum Oleoresin taken to prepare the Assay preparation,rUis the sum of the peak responses for nordihydrocapsaicin,capsaicin,and dihydrocapsaicin obtained from the Assay preparation,and rSis the peak response obtained from the Standard preparation.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 337
Phone Number:1-301-816-8343