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NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
81 | Cineole Type Niaouli Oil | IDENTIFICATION | chromatographic profile(Examine the chromatograms obtained in the test) | The characteristic peaks in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with reference solution (a). | |
Thin-layer chromatography | trans-nerolidol , cineole | ||||
TESTS | Relative density | 0.904 to 0.925 | |||
Refractive index | 1.463 to 1.472 | ||||
Optical rotation | -4 to +1 | ||||
Methyleugenol and isomethyleugenol(Gas chromatography) | "Limits: — methyleugenol: ≤ 0.05 % — isomethyleugenol: ≤ 0.05%" | ||||
chromatographic profile | "Determine the percentage Content of each of the following components. The limits are within the following ranges: — α-pinene: 5.0 % to 15.0 %; — β-pinene: 1.0 % to 4.0 %; — limonene: 5.0 % to 10.0 %; — 1,8-cineole: 45.0 % to 65.0 %; — p-cymene: 0.05 % to 4.0 %; — benzaldehyde: 0.05 % to 0.5 %; — α-terpineol: 3.0 % to 8.0 %; — trans-nerolidol: 0.05 % to 1.5 %; — viridiflorol: 2.5 % to 9.0 %; — disregard limit: the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 %)." | ||||
ASSAY | |||||
82 | Cinnamon | IDENTIFICATION | Microscopic examination | powder | powder,transverse section |
Thin-layer chromatography | cinnamic aldehyde,eugenol | cinnamaldehyde | |||
TESTS | Loss on drying | - | ≤15.0% | ||
Total ash | ≤6.0% | ≤5.0% | |||
ASSAY | Content | Minimum 12 mL/kg of essential oil. | "—essential oil,≥1.2%(ml/g) —cinnamaldehyde,≥1.5%" | ||
83 | Citronella Oil | IDENTIFICATION | chromatographic profile(Examine the chromatograms obtained in the test) | The characteristic peaks in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with the reference solution. Neral and geranial may be absent in the chromatogram obtained with the test solution. | |
Thin-layer chromatography | citronellal | ||||
TESTS | Relative density | 0.881 to 0.895 | |||
Refractive index | 1.463 to 1.475 | ||||
Optical rotation | -4 to +15 | ||||
chromatographic profile | "The percentages are within the following values: — limonene: 1.0 % to 5.0 %, — citronellal: 30.0 % to 45.0 %, — citronellyl acetate: 2.0 % to 4.0 %, — neral: ≤ 2.0 %, — geranial: ≤ 2.0 %, — geranyl acetate: 3.0 % to 8.0 %, — citronellol: 9.0 % to 15.0 %, — geraniol: 20.0 % to 25.0 %" | ||||
ASSAY | |||||
84 | Clematis Armandii Stem | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | hederagenin,oleanolic acid | reference drug | |||
TESTS | Aristolochia manshuriensis Kom. and other species of Aristolochia | Microscopic examination | - | ||
Aristolochic acids (2.8.21, Method A) | It complies with the test | - | |||
Loss on drying | ≤12.0% | ≤12.0% | |||
Total ash | ≤3.0% | ≤3.0% | |||
ASSAY | Ethanol-soluble extractive | - | ≥4.0% | ||
Content | ≥ 0.30% of oleanolic acid (dried drug) | ||||
85 | Clivers | IDENTIFICATION | Microscopic examination | powder | |
high performance thin-layer chromatography | hyperoside,chlorogenic acid,rutin | ||||
TESTS | Foreign matter | ≤2.0% | |||
Ash insoluble in hydrochloric acid | ≤2.0% | ||||
DNA reference sequence | A DNA reference sequence for the identity of Galium aparine is published in Supplementary Chapter VII D | ||||
ASSAY | |||||
86 | Clove | IDENTIFICATION | Microscopic examination | powder | powder,transverse section |
Thin-layer chromatography | eugenol | eugenol | |||
TESTS | Foreign matter | ≤6% of peduncles, petioles and fruits, ≤2% of deteriorated cloves and ≤0.5% of other foreign matter. | ≤4% | ||
Total ash | ≤7.0% | - | |||
Loss on drying | - | ≤12.0% | |||
ASSAY | Content | ≥150 mL/kg of essential oil | eugenol, ≥11.0% | ||
87 | Clove Oil | IDENTIFICATION | chromatographic profile(Examine the chromatograms obtained in the test) | The 3 principal peaks in chromatogram obtained with the test solution are similar in retention time to the 3 principal peaks in the chromatogram obtained with the reference solution | The 3 principal peaks in chromatogram obtained with the test solution are similar in retention time to the 3 principal peaks in the chromatogram obtained with the reference solution |
Thin-layer chromatography | eugenol,acetyleugenol | eugenol,acetyleugenol | |||
TESTS | Relative density | 1.030 to 1.063 | 1.038~1.060 | ||
Refractive index | 1.528 to 1.537 | 1.528 to 1.537 | |||
Optical rotation | -2.0° to 0° | -2.0° to 0° | |||
Fatty oils and resinified essential oils(2.8.7) | It complies with the test | - | |||
Solubility in alcohol | 1.0 mL is soluble in 2.0 mL and more of ethanol (70 % V/V) R | - | |||
chromatographic profile | "Determine the percentage Content of each of these components. The limits are within the following ranges: — β-caryophyllene: 5.0 % to 14.0 %; — eugenol: 75.0 % to 88.0 %; — acetyleugenol: 4.0 % to 15.0 %." | - | |||
ASSAY | Clarity of Solution(general rule 0902) | solution clear | |||
Water-soluble phenols | blue and purple are absent from the solution obtained with the test solution. | ||||
Fatty oils and resinized essential oils | Translucent or oily spots are absent | ||||
Heavy metal(general rule 0821method B), | ≤10ppm | ||||
Content | β-caryophyllene:5.0%~14.0%,ugenol:75.0%~88.0%,acetyl eugenol :4.0%~15.0% | ||||
88 | Cocoa Butter | IDENTIFICATION | Solubility | Freely soluble in boiling anhydrous ethanol and in light petroleum, slightly soluble in ethanol (96%) | Freely soluble in boiling anhydrous ethanol and in light petroleum, slightly soluble in ethanol (96%) |
Relative density | About 0.895 at 40 °C | About 0.895~0.904 at 40 °C | |||
Refractive index | About 1.457 at 40 °C | About 1.456~1.458 at 40 °C | |||
iodine value | - | 35 to 40 | |||
Melting point | 31 to 35 °C | 31 to 34 °C | |||
Composition of fatty acids | see Tests | The peaks in chromatogram obtained with the test solution are similar in retention time to the peaks in the chromatogram obtained with the reference solution(methyl palmitate,methyl stearate,methyl oleate,methyl linoleate) | |||
TESTS | Acid value | ≤4.0 | ≤2.8 | ||
Peroxide value | ≤3.0 | - | |||
Saponification value | 188 to 198, determined on 2.5 g. | 188 to 195 | |||
Alkaline impurities | physiochemical identification | - | |||
Composition of fatty acids | "Composition of the fatty-acid fraction of the substance: — lauric acid: ≤ 0.5 %; — myristic acid: ≤ 0.5 %; — palmitic acid: 24.0 % to 31.0 %; — stearic acid: 30.0 % to 38.0 %; — oleic acid: 31.0 % to 38.0 %; — linoleic acid: ≤ 4.5 %;" | "Composition of the fatty-acid fraction of the substance: — linolenic acid: ≤ 1.5 %; — arachidic acid: ≤ 1.5 %; — palmitic acid: 23% to 30%; — stearic acid: 310 % to 37 %; — oleic acid: 31 % to 38 %; — linoleic acid: 1.6%~4.8 %;" | |||
ASSAY | |||||
89 | Codonopsis Root | IDENTIFICATION | Microscopic examination | powder | transverse section |
Thin-layer chromatography | Xylose,Glucose | lobetyolin | |||
TESTS | Platycodon grandiflorus(Thin-layer chromatography) | Xylose,Glucose | - | ||
Loss on drying | ≤12.0% | ≤16.0% | |||
Total ash | ≤6.0% | ≤5.0% | |||
Ash insoluble in hydrochloric acid | ≤2.5% | - | |||
Sulfur dioxide | - | ≤400 ppm | |||
ASSAY | Extractable matter | ≥21.0% | - | ||
Ethanol-soluble extractive | ≥55.0% | ||||
90 | Coix Seed | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | oleic acid, triolein | Coix seed oil control extract, triglyceride | |||
TESTS | Foreign matter | - | ≤2% | ||
Loss on drying | ≤12.0% | ≤15.0% | |||
Total ash | ≤3.0% | ≤3.0% | |||
Aflatoxin | - | ≤5ppb of Aflatoxin B1,≤10ppb of sum of Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2 | |||
zearalenone | - | ≤500 ppb of zearalenone | |||
Ethanol-soluble extractive | - | ≥5.5% | |||
ASSAY | Content | glycerin trioleate | |||
91 | Cola | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | caffeine , theobromine | ||||
TESTS | Loss on drying | ≤12.0% | |||
Total ash | ≤9.0% | ||||
ASSAY | Content | ≥1.5% of caffeine (dried drug) | |||
92 | Colophony | IDENTIFICATION | Thin-layer chromatography | thymol, linalol | |
TESTS | Acid value | 145 to 180, determined on 1.0 g | 150~177 | ||
Total ash | ≤0.2% | ||||
softening point | ≥76℃ | ||||
ethanol-insoluble matter | ≤0.030% | ||||
unsaponifiable matter | ≤5.0% | ||||
Ignited residue | ≤0.1% | ||||
ASSAY | heavy metal | ≤20ppm | |||
97 | Compound Podophyllin Paint | IDENTIFICATION | Thin-layer chromatography | podophyllotoxin,phenazone | |
TESTS | Weight per mL | 0.925 to 0.975 g | |||
Total solids | 27.0 to 33.0% w/v | ||||
ASSAY |