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variable number of low-intensity dark-gray bands appear between 10- and the second prominent band DEFINITION corresponding to 6- in Standard solution A. In the Ginger is the dried of Zingiber officinale Roscoe (Fam. distal part of the chromatogram, a dark-purple ), scraped, partially scraped, or unscraped. It is somewhat diffuse band is observed. Under long-wave known in commerce as unbleached ginger. UV (365 nm), the chromatograms of the Standard solutions exhibit patterns similar to those observed under IDENTIFICATION white light. The bands due to and are • A. bright orange; the bands between the origin and the Analysis: Pulverize 5 g of Ginger. To 1 g of the pulverized 6-gingerol band are dark-red to brown, somewhat less Ginger add 5 mL of dilute acetic acid, prepared by diluting prominent than when observed in white light. The 1 part of glacial acetic acid with 1 part of water, and shake bands between 10-gingerol and 6-shogaol are variably for 15 min. Filter, and add a few drops of ammonium colored; frequently, a light-gray band appears halfway oxalate TS to the filtrate. between them, with a light-purple diffuse band between Acceptance criteria: NMT a slight turbidity is produced. it and the orange band due to 6-shogaol. The distal • B. diffuse band assumes a purple-pink hue. Sample: 50 mg of the residue obtained in the test for Articles Analysis of Botanical Origin, Alcohol-Soluble Extractives, Method 2 Samples: Standard solution A, Standard solution B, and Analysis: Dissolve the Sample in 25 mL of water, and extract Sample solution this solution with two 15-mL portions of ether. Combine Treat and examine the Samples as described under System the ether extracts, and evaporate in a porcelain dish. To the suitability. residue add 5 mL of sulfuric acid solution (7.5 in 10.0) and Acceptance criteria: Under white light and under 5 mg of . Allow to stand for 15 min, and add an equal long-wave UV (365 nm), the chromatogram of the Sample volume of water. solution exhibits the band pattern similar to that observed Acceptance criteria: The solution turns azure blue. with Standard solution B. The band in the distal part of the • C. HPTLC FOR ARTICLES OF BOTANICAL ORIGIN á203ñ chromatogram, however, has no diagnostic significance. Its Standard solution A: 0.2 mg/mL of USP Ginger Constituent color may range from purple-pink to muddy yellow, or the Mixture RS in methanol band may be altogether absent. Potential adulterants lack Standard solution B: 100 mg/mL of USP Powdered the band pattern characteristic of the gingerol–shogaol Ginger RS in methanol. Sonicate for 10 min, and centrifuge succession. Kaempferia galanga L. rhizome shows no or filter. Use supernatant or filtrate. diagnostic bands under UV, but under white light a purple Sample solution: Pulverize 5 g of Ginger. Prepare a band is seen at about two-thirds from the application line. 100-mg/mL dispersion of Ginger in methanol. Sonicate for Lesser (Alpinia officinarum Hance) rhizome 10 min, and centrifuge or filter. Use supernatant or filtrate. presents a yellow band at an RF just below the 6-gingerol Adsorbent: Chromatographic silica gel with an average band, followed by a continuous broad blue smudge, and a particle size of 5 µm (HPTLC plate)1 distinct tandem of light-orange and yellow bands close to Application volume: 6 µL of Standard solution A and 2 µL the middle of the plate. each of Standard solution B and Sample solution as 8-mm bands COMPOSITION Temperature: Ambient, not to exceed 30° • CONTENT OF GINGEROLS AND GINGERDIONES Developing solvent system: Toluene and ethyl acetate Solution A: Acetonitrile, dilute phosphoric acid (1 in 1000), (3:1) and methanol (55:44:1) Derivatization reagent: To 170 mL of ice-cold methanol Solution B: Acetonitrile add 20 mL of glacial acetic acid, 10 mL ofOfficial sulfuric acid, and Mobile phase: Use Solution A for NLT 7 times the retention 1 mL of anisaldehyde. Mix well. time of . System suitability Column washing: After each chromatographic run, wash Samples: Standard solution A and Standard solution B the column, using Table 1. Apply the Samples and dry in air. Condition at relative humidity of about 33%. Develop in a saturated chamber Table 1 until the solvent front has migrated over a path of 6 cm. Time Solution A Solution B Dry in a current of cold air, and immerse into (min) (%) (%) Derivatization reagent for 1 s. Heat for 3 min at 100°, and 0 100 0 examine under white light and under long-wave UV (365 nm). 2 0 100 Suitability requirements 12 0 100 Chromatographic pattern: Under white light, the derivatized chromatogram of Standard solution A 14 100 0 displays two prominent bands: the lower due to 29 100 0 6-gingerol, the upper due to 6-shogaol. Under white light, the derivatized chromatogram of Standard solution Standard solution: 0.1 mg/mL of USP Capsaicin RS in B shows a succession of dark-violet bands between the methanol origin and the intense dark-brown band corresponding System suitability solution: Reconstitute the content of to that of the 6-gingerol in Standard solution A. one vial of USP Ginger Constituent Mixture RS in 1 mL of Immediately proximate to the 6-gingerol band in the the Standard solution. Standard solution B chromatogram, less intense bands Sample solution: Use the filtrate retained from the test for due to 8-gingerol and 10-gingerol are observed. A Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 2. 1 Chromatographic system Suitable commercially available plates are HPTLC Silica Gel 60 F254 from EMD Millipore (e.g., Part No. 1.05642.0001). (See Chromatography á621ñ, System Suitability.)

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Mode: LC stele, and numerous yellowish points, secretion cells and Detector: UV 282 nm numerous bigger grayish points, and vascular bundles are Column: 4.6-mm × 25-cm; packing L1 scattered on the whole surface. The unscraped rhizome Flow rate: 1 mL/min shows in addition an outer layer of dark-brown cork. Injection volume: 25 µL Morphological characteristics of different varieties and System suitability forms of Ginger from different geographical areas are Samples: Standard solution and System suitability solution listed in Table 1 of Supplemental Information for Articles of [NOTE—The relative retention times for 6-gingerol, Botanical Origin á2030ñ. capsaicin, and 6-shogaol are about 0.8, 1.0, and 1.9, Microscopic: The scraped rhizome in transverse section respectively, System suitability solution.] shows a cortex composed of multiple layers of parenchyma Suitability requirements cells rich in simple, large, flattened, ovoid or sack-shaped Resolution: NLT 3.0 between the 6-gingerol and starch granules, 5–15 µm wide and 30–60 µm long having capsaicin peaks; NLT 10.0 between the capsaicin and an eccentric hilum, some showing faint transverse 6-shogaol peaks, System suitability solution striations. The cortex also shows numerous cells Tailing factor: NMT 2.0 for the 6-gingerol, capsaicin, with a yellow or yellowish-brown content and scattered and 6-shogaol peaks, System suitability solution collateral vascular bundles; a single layer of endodermal Relative standard deviation: NMT 2.5%, Standard cells free from starch; a wide central stele composed of solution parenchyma cells rich in starch and oleoresin cells similar to Analysis those of the cortex, and containing scattered collateral Samples: Standard solution, System suitability solution, and vascular bundles, some enclosed in a sheath of septate Sample solution nonlignified fibers with wide lumen. In addition to the Calculate the sum of the peak responses due to gingerols above, the unscraped rhizome shows an outer zone of and gingerdiones occurring at about the following dark-brown cork cells. retention times, relative to 1.0 for capsaicin: 0.8 for • LIMIT OF SHOGAOLS 6-gingerol, 1.5 for 8-gingerol A, 2.2 for 8-gingerol B, Analysis: From the chromatograms obtained in the test for 2.5 for 6-gingerdiol, 2.6 for 6-gingerdione, 3.4 for Content of Gingerols and Gingerdiones, calculate the sum of 10-gingerol, and 5.2 for 8-gingerdione. the peak responses due to shogaols, occurring at the Calculate the percentage of gingerols and gingerdiones in following retention times, relative to 1.0 for capsaicin: the portion of Ginger taken: 1.9 for 6-shogaol, 4.2 for 8-shogaol, and 5.8 for 10-shogaol. Result = (rT/rS) × (CS/W) × 10 Calculate the percentage of shogaols in the portion of Ginger taken: rT = sum of the peak responses for gingerols and gingerdiones from the Sample solution Result = (rT/rS) × (CS/W) × 10 rS = peak response of capsaicin from the Standard solution rT = sum of the peak responses of shogaols from the CS = concentration of USP Capsaicin RS in the Standard Sample solution solution (mg/mL) rS = peak response of capsaicin from the Standard W = weight of Ginger used in the test for Articles of solution Botanical Origin, Alcohol-Soluble Extractives, CS = concentration of USP Capsaicin RS in the Standard Method 2 (g) solution, prepared as directed in the test for Content of Gingerols and Gingerdiones (mg/mL) Acceptance criteria: NLT 0.8% W = weight of Ginger used in the test for Articles of Botanical Origin, Alcohol-Soluble Extractives, CONTAMINANTS Official Method 2 (g) • ARTICLES OF BOTANICAL ORIGIN, Limits of Elemental Impurities á561ñ: Meets the requirements Acceptance criteria: NMT 0.18% • ARTICLES OF BOTANICAL ORIGIN, Pesticide Residue Analysis • ARTICLES OF BOTANICAL ORIGIN, Alcohol-Soluble Extractives, á561ñ: Meets the requirements Method 2 á561ñ • MICROBIAL ENUMERATION TESTS á2021ñ: The total bacterial Analysis: Collect the filtrate in a 100-mL volumetric flask, count does not exceed 105 cfu/g, the total combined molds 3 and dilute with alcohol to volume. Evaporate 50 mL of the and yeasts count does not exceed 10 cfu/g, and the filtrate at a temperature not exceeding 90°. [NOTE—Save bile-tolerant Gram-negative bacteria count does not 3 the residue for use in Identification test B and the remaining exceed 10 cfu/g. volume of the filtrate for the tests for Limit of Shogaols and • ABSENCE OF SPECIFIED MICROORGANISMS á2022ñ: It meets Content of Gingerols and Gingerdiones.] the requirements of the tests for absence of Salmonella Acceptance criteria: NLT 4.5% residue species and Escherichia coli. • ARTICLES OF BOTANICAL ORIGIN, Starch Content, Method 1 SPECIFIC TESTS á561ñ: NLT 42%, Method 1A of the General Procedure • BOTANICAL CHARACTERISTICS being used Macroscopic: Ginger occurs in horizontal, laterally • ARTICLES OF BOTANICAL ORIGIN, Foreign Organic Matter flattened, sympodially branching pieces. Whole á561ñ: NMT 1.0% are 5–15 cm long, 1.5–6 cm wide, and up to 2 cm thick, • ARTICLES OF BOTANICAL ORIGIN, Total Ash á561ñ: NMT sometimes split longitudinally, pale yellowish buff or light 8.0% brown externally, longitudinally striated, somewhat • ARTICLES OF BOTANICAL ORIGIN, Acid-Insoluble Ash á561ñ: fibrous; branches are flattish, obovate, short, about 2 cm NMT 2.0% long, each ending with a depressed stem scar; fracture is • ARTICLES OF BOTANICAL ORIGIN, Volatile Oil Determination short with projecting fibers, or sometimes resinous; á561ñ: NLT 1.8 mL/100 g internally it is yellowish brown, showing a yellow • ARTICLES OF BOTANICAL ORIGIN, Water-Soluble Ash á561ñ: endodermis separating the narrow cortex from the wide NLT 1.9%

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• ARTICLES OF BOTANICAL ORIGIN, Water-Soluble Extractives, article. This article is exempted from the requirements of Method 2 á561ñ: NLT 10.0% Labeling á7ñ, Labels and Labeling for Products and Other • WATER DETERMINATION, Method Ia á921ñ: NMT 10% Categories, Botanicals, with respect to the pregnancy and lactation statement. ADDITIONAL REQUIREMENTS • USP REFERENCE STANDARDS á11ñ • PACKAGING AND STORAGE: Preserve in well-closed USP Capsaicin RS containers, protected from light and moisture, and store USP Ginger Constituent Mixture RS in a cool area. USP Powdered Ginger RS • LABELING: The label states the Latin binomial and, following the official name, the part of the plant contained in the

Official

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