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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).
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