红景天提取物-USP38版.pdf
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1、6198 Rhodiola rosea/Dietary SupplementsUSP 38V=volume of the Sample solution(mL)It contains NLT 90.0%and NMT 110.0%of the labeledW=weight of Powdered Rhodiola rosea taken toamount of phenylpropenoid glycosides calculated as theprepare the Sample solution(g)sum of rosarin,rosavin,and rosin,and NLT 90
2、.0%andAcceptance criteria:NLT 0.3%of phenylpropenoid gly-NMT 110.0%of the labeled amount of salidroside,bothcosides and NLT 0.08%of salidroside,both calculatedcalculated on the dried basis.It may contain suitableon the dried basisadded substances as carriers.CONTAMINANTSIDENTIFICATION ELEMENTAL IMPU
3、RITIESPROCEDURES 233 A.THIN-LAYER CHROMATOGRAPHYAcceptance criteriaStandard solution A:1.0 mg/mL of USP Rosavin RS inArsenic:NMT 2.0 g/gmethanolCadmium:NMT 1.0 g/gStandard solution B:50 mg/mL of USP Rhodiola roseaLead:NMT 5.0 g/gRoot and Rhizome Dry Extract RS in methanol.SonicateMercury:NMT 1.0 g/g
4、for 10 min,centrifuge,and use the supernatant.ARTICLES OF BOTANICAL ORIGIN,General Method for Pesti-Sample solution:50 mg/mL of Powdered Rhodiolacide Residues Analysis 561:Meets the requirementsrosea Extract in methanol.Sonicate for 10 min,centri-MICROBIAL ENUMERATION TESTS 2021:The total aerobicfug
5、e,and use the supernatant.bacterial count does not exceed 105.cfu/g,the total com-Chromatographic systembined molds and yeasts count does not exceed 103.cfu/(See Chromatography 621,Thin-Layer Chromato-g,and the bile-tolerant Gram-negative bacteria countgraphy.)does not exceed 103.cfu/g.Adsorbent:Chr
6、omatographic silica gel with an aver-ABSENCE OF SPECIFIED MICROORGANISMS 2022:Meets theage particle size of 5 m(HPTLC plates)requirements of the tests for absence of Salmonella spe-Application volume:3 L of Standard solution A andcies and Escherichia coli5 L each of Standard solution B and the Sampl
7、e solu-ARTICLES OF BOTANICAL ORIGIN,Test for Aflatoxins 561:tion;as 8-mm bandsMeets the requirementsRelative humidity:Condition the plate to a relativehumidity of about 33%using a suitable device.SPECIFIC TESTSDeveloping solvent system:A mixture of ethyl ace-BOTANIC CHARACTERISTICState,methanol,wate
8、r,and formic acid(77:13:10:2)Macroscopic:Pinkish-brown or light brown in colorDeveloping distance:6 cmMicroscopic It shows fragments of cork cells,sub-Derivatization reagent:Dissolve 1 g of diphenylaminerectangular or polygonal,containing yellowish-brownin 40 mL of acetone,add 1 mL of aniline,and mi
9、x.pigments,10150 m in diameter;parenchymatousCarefully add 7.5 mL of phosphoric acid,and mix.cells of cortex,subsquare or polygonal,containing red-Analysisdish-brown pigments;stone cells,subrounded,subtri-Samples:Standard solution A,Standard solution B,andangular,subrectangular or irregular shape,so
10、me elon-Sample solutiongated,mostly 1470 m in diameter,up to 270 m inApply the samples as bands to a suitable high perfor-length;fibers mostly in bundles,long fusiform in shape,mance thin-layer chromatographic plate,and dry inends oblique-sharp or blunt-round,with oblique orair.Develop the chromatog
11、rams in a saturated cham-criss-cross striations,1060 m in diameter;and reticu-ber,remove the plate from the chamber,and dry inlate and pitted vessels,up to 120 m in diameter.air.Derivatize the plate with Derivatization reagent,LOSS ON DRYING 731heat at 120 for 5 min,and examine under visibleSample:1
12、.0 g of Powdered Rhodiola rosealight.Analysis:Dry at 105 for 2 h.System suitability:The chromatogram of Standard solu-Acceptance criteria:NMT 12%tion B exhibits,in the lower half,three gray bands and ARTICLES OF BOTANICAL ORIGIN,Total Ash 561two brownish bands,one above and the other belowSample:2 g
13、 of Powdered Rhodiola roseathe gray bands;the most intense band in the chromat-Acceptance criteria:NMT 12%ogram is the brownish band with an RF below the gray ARTICLES OF BOTANICAL ORIGIN,Acid-Insoluble Ash 561bands;the most intense gray band is the lower band atSample:24 g of Powdered Rhodiola rose
14、aan RF corresponding to the band due to rosavin in theAcceptance criteria:NMT 3%chromatogram of Standard solution A;the upper grayband due to rosarin is less intense.ADDITIONAL REQUIREMENTSAcceptance criteria:The chromatogram of the Sample PACKAGING AND STORAGE:Preserve in well-closed contain-soluti
15、on exhibits a gray band corresponding to the banders,protected from light and moisture,and store atdue to rosavin in the chromatogram of Standard solu-room temperature.tion A,and the following bands corresponding to simi-LABELING:The label states the Latin binomial and,follow-lar bands in the chroma
16、togram of Standard solution B:ing the official name,the parts of the plant from whichtwo additional gray bands and two brownish bands,the article was obtained.one above and the other below the gray bands;the USP REFERENCE STANDARDS 11most intense band in the chromatogram is the brown-USP Rhodiola ro
17、sea Root and Rhizome Dry Extract RSish band with an RF below the gray bands;the mostUSP Rosavin RSintense gray band is the lower band due to rosavin.USP Salidroside RS B.HPLCAnalysis:Proceed as directed in the test for Content ofPhenylpropenoid Glycosides and Salidroside.Acceptance criteria:The chro
18、matogram of the Sample.solution exhibits peaks at the retention times corre-Powdered Rhodiola rosea Extractsponding to the peaks due to salidroside,tyrosol,rosarin,rosavin,rosin,and rosiridin in the chromato-DEFINITIONgram of Standard solution C.The ratio of the contentsPowdered Rhodiola rosea Extra
19、ct is prepared from Rhodiolaof rosarin,rosavin,and rosin is about 2.5:6.0:1.5,rosea by extraction with hydroalcoholic mixtures.The ra-respectively.tio of plant material to extract is between 1.5:1 and 5:1.DS MonographsOfficial from August 1,2015Copyright(c)2015 The United States Pharmacopeial Conven
20、tion.All rights reserved.Accessed from 10.6.1.1 by Norbr00k9 on Thu Oct 15 02:58:17 EDT 2015USP 38Dietary Supplements/Rhodiola rosea 6199COMPOSITIONCalculate the percentage of phenylpropenoid glycosides CONTENT OF PHENYLPROPENOID GLYCOSIDES AND SALIDROSIDEas the sum of the percentages of rosarin,ros
21、avin,andSolution A:Waterrosin.Solution B:AcetonitrileCalculate the percentage of salidroside in the portion ofMobile phase:See Table 1.Powdered Rhodiola rosea Extract taken:P2=(rU/rS)(CS/CU)100Table 1rU=peak area of salidroside from the SampleTimeSolution ASolution Bsolution(min)(%)(%)rS=peak area o
22、f salidroside from Standard solution0946B68317CS=concentration of salidroside in Standard780.319.7solution B(mg/mL)980.319.7CU=concentration of Powdered Rhodiola rosea100100Extract in the Sample solution(mg/mL)Calculate the percentage of the labeled amount of12946phenylpropenoid glycosides in the po
23、rtion of17946Powdered Rhodiola rosea Extract taken:Standard solution A:1.0 mg/mL of USP Rosavin RS inResult=(P1/L)100methanolStandard solution B:0.3 mg/mL of USP Salidroside RSP1=content of phenylpropenoid glycosides,asin methanoldetermined above(%)Standard solution C:4.0 mg/mL of USP Rhodiola rosea
24、L=labeled amount of phenylpropenoid glycosidesRoot and Rhizome Dry Extract RS in methanol.Sonicate(%)to dissolve,if necessary.Before injection,pass through aCalculate the percentage of the labeled amount ofmembrane filter of 0.45-m or finer pore size.salidroside in the portion of Powdered Rhodiola r
25、oseaSample solution:4.0 mg/mL of Powdered RhodiolaExtract taken:rosea Extract in methanol.Sonicate to dissolve,if neces-sary.Before injection,pass through a membrane filterResult=(P2/L)100of 0.45-m or finer pore size.Chromatographic systemP2=content of salidroside,as determined above(See Chromatogra
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