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NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
256 | Oregano | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | thymol,carvacrol | ||||
TESTS | Water | ≤ 120 mL/kg | |||
Total ash | ≤ 15.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 4.0 % | ||||
ASSAY | Content | "Content — essential oil: ≥ 25 mL/kg (anhydrous drug); — sum of the Contents of carvacrol and thymol: ≥ 60 % in the essential oil" | |||
257 | Orientvine Stem | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | sinomenine,papaverine | ||||
TESTS | Loss on drying | ≤ 10.0 % | |||
Total ash | ≤ 6.0 % | ||||
ASSAY | Content | Minimum 0.5 per cent of sinomenine (C19H23NO4; Mr 329.4) (dried drug). | |||
261 | Passionflower Herb | IDENTIFICATION | Microscopic examination | powder | |
High-performance thin-layer chromatography | homoorientin,isovitexin,isovitexin,orientin | ||||
TESTS | Loss on drying | ≤ 10.0 % | |||
Total ash | ≤ 13.0 % | ||||
ASSAY | Content | ≥ 1.0 %of total flavonoids, expressed as isovitexin(dried drug) | |||
262 | Passionflower Herb Dry Extract | IDENTIFICATION | High-performance thin-layer chromatography | homoorientin,isovitexin,isovitexin,orientin | |
TESTS | Water | ≤ 5.0 % | |||
ASSAY | Content | ≥ 1.5 %of total flavonoids, expressed as isovitexin (anhydrous extract) | |||
263 | Peach Seed | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | amygdalin and sucrose | ||||
TESTS | Loss on drying | ≤8.0% | ≤7.0% | ||
Total ash | ≤4.0% | ||||
Foreign matter | ≤2% | ||||
Peroxide value | ≤9.0% | ≤10.0% | |||
Pb, Cr, As, Hg and Cu | Pb ≤5ppm, Cr≤1ppm, As2ppm, Hg ≤0.2ppm, Cu≤20ppm | ||||
Aflatoxin | ≤5ppb of Aflatoxin B1,≤10ppb of sum of Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2 | ||||
ASSAY | Content | ≥2.0% of amygdalin (C20H27NO11; Mr 457.4) (dried drug). | ≥2.0% of amygdalin (C20H27NO11; Mr 457.4) (dried drug). | ||
264 | Pelargonium Root | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | scopoletin,esculin | ||||
TESTS | Loss on drying | ≤ 12.0 % | |||
Total ash | ≤ 12.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 3.0 % | ||||
ASSAY | Content | ≥ 2.0 %of tannins, expressed as pyrogallol (dried drug) | |||
265 | Pepper | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | borneol, piperine | ||||
physiochemical identification | |||||
TESTS | Foreign matter | ≤ 3 %. | |||
Water | ≤ 120 mL/kg | ||||
Total ash | ≤ 6.0 % | ||||
Loss on drying | |||||
ASSAY | Content | "— essential oil: ≥ 25 mL/kg (anhydrous drug); — piperine (C17H19NO3; Mr 285.3): ≥ 3.0 %(anhydrous drug)." | |||
266 | Peppermint Leaf | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | Rosmarinic acid,Luteolin-7-glucoside,Rutoside | ||||
physiochemical identification | |||||
TESTS | Foreign matter | "≤ 5 %of stems, whose diameter is not greater than 1.5 mm; ≤ 2 %of foreign elements; not more than 8 %of the leaves show brown stains due to Puccinia menthae." | |||
Water | ≤ 110 mL/kg, determined on 20.0 g | ||||
Total ash | ≤ 15.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 1.5 % | ||||
loss on drying | |||||
leaf | |||||
ASSAY | Content | "Essential oil Content: — for the whole drug, ≥ 12 mL/kg (anhydrous drug); — for the cut drug, ≥ 9 mL/kg (anhydrous drug)." | |||
267 | Peppermint Leaf Dry Extract | IDENTIFICATION | Thin-layer chromatography | luteolin-7-glucoside ,rutoside trihydrate ,rosmarinic acid | |
TESTS | |||||
ASSAY | Content | ≥ 0.5 %of rosmarinic acid (dried extract) | |||
268 | Peppermint Oil | IDENTIFICATION | Thin-layer chromatography | menthol ,cineole, thymol, menthyl acetate | |
Examine the chromatograms obtained in the test for chromatographic profile. | The characteristic peaks due to limonene, 1,8-cineole, menthone, menthofuran, isomenthone, menthyl acetate and menthol in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with reference solution (a). Isopulegol, pulegone and carvone may be present in the chromatogram obtained with the test solution. | ||||
TESTS | Refractive index | 0.900 to 0.916 | |||
Relative density | 1.457 to 1.467 | ||||
Relative density | -30° to -10° | ||||
Acid value | ≤ 1.4 | ||||
Fatty oils and resinified essential oils | It complies with the test for fatty oils and resinified essential oils | ||||
Mint oil(Examine the chromatograms obtained in the test for chromatographic profile) | The chromatogram obtained with the test solution does not show a peak with the retention time of isopulegol that has an area of more than 0.2 %of the total area. | ||||
ASSAY | Chromatographic profile | "The limits are within the following ranges: — limonene: 1.0 %to 3.5 %; — 1,8-cineole: 3.5 %to 8.0 %; — menthone: 14.0 %to 32.0 %; — menthofuran: 1.0 %to 8.0 %; — isomenthone: 1.5 %to 10.0 %; — menthyl acetate: 2.8 %to 10.0 %; — isopulegol: ≤ 0.2 %; — menthol: 30.0 %to 55.0 %; — pulegone: ≤ 3.0 %; — carvone: ≤ 1.0 %; — disregard limit: the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 %). The ratio of 1,8-cineole Content to limonene Content is a ≥ of 2." | |||
270 | Peru Balsam | IDENTIFICATION | Thin-layer chromatography | thymol , benzyl cinnamate and benzyl benzoate | |
TESTS | Relative density | 1.14 to 1.17 | |||
Saponification value | 230 to 255, determined on the residue obtained in the assay | ||||
Fatty oils | Shake 1 g with 3 mL of a 1000 g/L solution of chloral hydrate R. The resulting solution is as clear as the 1000 g/L solution of chloral hydrate R. | ||||
ASSAY | Content | 45.0 to 70.0 % m/m of esters, mainly benzyl benzoate and benzyl cinnamate. | |||
271 | Phellodendron Amurense Bark | IDENTIFICATION | Microscopic examination | ||
Thin-layer chromatography | palmatine chloride , berberine chloride | obtusone | |||
TESTS | Loss on drying | ≤10.0% | ≤11.0% | ||
Total ash | ≤8.0% | ≤9.0% | |||
ASSAY | Content | ≥0.4% w/w of berberine (C20H18NO4 ) and not less than 0.2% w/w palmatine (C21H22NO4 ) calculated with reference to the dried material | ≥Berberine hydrochloride(GoH】7N04 • HC1)Palmatine hydrochloride0. 60%,(Qi H2] NO4 • HC1)0. 30% | ||
272 | Phellodendron Chinense Bark | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | palmatine chloride and berberine chloride | Phelloconine hydrochloride | |||
TESTS | Loss on drying | ≤10.0% | ≤12.0% | ||
Total ash | ≤8.0% | ≤8.0% | |||
ASSAY | Content | ≥ 3.0% w/w of berberine (C20H18NO4 ), calculated with reference to the dried material. | geniposide,≥1.8% | ||
273 | Phyllanthus Emblica Pericarp | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | gallic acid | reference drug | |||
TESTS | Loss on drying | ≤10.0% | ≤13.0% | ||
Ash | ≤7.0% | ≤5.0% | |||
Foreign matter | ≤5% | ||||
ASSAY | Content | ≥6.0% tannins, expressed as pyrogallol (C6H6O3 . Mr 126.1), calculated with reference to the dried drug. | gallic acid,≥1.2% | ||
Ethanol-soluble extractive | ≥15.0% | ||||
Water-soluble extractive | ≥50.0% | ≥30.0% | |||
275 | Plantain | IDENTIFICATION | Microscopic examination | powder | |
TESTS | Loss on drying | ≤10.0% | |||
Total ash | ≤14.0% | ||||
Foreign matter | ≤5% | ||||
ASSAY | Content | ≥ 1.5 % of total ortho-dihydroxycinnamic acid derivatives expressed as acteoside (C29H36O15; Mr 624.6) (dried drug). |