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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
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