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NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
61 | Cape Aloes | IDENTIFICATION | Thin-layer chromatography | Aloe emodin,Barbaloin | |
TESTS | Barbados aloes | Aloe emodin,Barbaloin | |||
Loss on drying | ≤10.0% | ||||
Total ash | ≤2.0% | ||||
ASSAY | Content | ≥18.0% of hydroxyanthracene derivatives, expressed as barbaloin (dried drug) | |||
62 | Cape Jasmine Fruit | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | aescin, geniposide | reference drug, geniposide | |||
TESTS | Loss on drying | ≤8.5% | ≤8.5% | ||
Total ash | ≤6.0% | ≤6.0% | |||
Pb, Cr, As, Hg and Cu | - | Pb ≤5ppm, Cr≤1ppm, As2ppm, Hg ≤0.2ppm, Cu≤20ppm | |||
ASSAY | Content | ≥2.0% of geniposide (dried drug). | geniposide,≥1.8% | ||
63 | Capsicum Tincture | IDENTIFICATION | Thin-layer chromatography | capsaicin,dihydrocapsaicin | |
TESTS | Nonivamide(Thin-layer chromatography) | capsaicin,dihydrocapsaicin | |||
Ethanol | 83 to 88 % v/v | ||||
Methanol | ≤0.05 % v/v | ||||
ASSAY | Content | 0.036 to 0.044 % w/v of total capsaicinoids, expressed as capsaicin | |||
64 | Capsicum | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | capsaicin,dihydrocapsaicin | capsaicine | |||
TESTS | Nonivamide(Thin-layer chromatography) | capsaicin,nonivamide | - | ||
foreign matter | Fruits of C. annuum L. var. longum (Sendtn.) are absent | - | |||
Loss on drying | ≤11.0% | ≤13.0% | |||
Total ash | ≤10.0% | - | |||
ASSAY | Content | ≥0.4% of total capsaicinoids, expressed as capsaicin (dried drug) | sum of capsaicine and dihydrocapsaicin,≥0.16% | ||
65 | Caraway | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | carvone,olive oil | ||||
TESTS | Water | ≤ 100 mL/kg | |||
Total ash | ≤7.0% | ||||
ASSAY | Content | ≥ 30 mL/kg of essential oil (anhydrous drug) | |||
66 | Caraway Oil | IDENTIFICATION | Thin-layer chromatography | carvone | |
Chromatographic profile | "Examine the chromatograms obtained in the test for chromatographic profile. Results: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" | ||||
TESTS | Relative density | 0.904 to 0.920 | |||
Refractive index | 1.484 to 1.490 | ||||
Optical rotation | +65 to +81 | ||||
Acid value | ≤ 1.0 | ||||
Chromatographic profile | "Limits: — β-myrcene: 0.1% to 1.0%, — limonene: 30.0% to 45.0%, — trans-dihydrocarvone: ≤ 2.5%, — carvone: 50.0% to 65.0%, — trans-carveol: ≤ 2.5%. — disregard limit: the area of the peak in the chromatogram obtained with reference solution (b)." | ||||
Chiral purity | (-)-carvone:≤1%. | ||||
ASSAY | |||||
67 | Cardamom Fruit | IDENTIFICATION | Macroscopical | Macroscopical Fruit | |
Microscopical | Microscopical Seed | ||||
TESTS | Foreign matter | Of the fruit, ≤1.0%;of the separated seeds, ≤3.0% | |||
Volatile oil | In the seeds, ≥ 4.0% v/w | ||||
Acid-insoluble ash | Of the seeds, ≤3.5% | ||||
Ash | Of the seeds, ≤ 6.0% | ||||
ASSAY | |||||
69 | Cascara | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | barbaloin | ||||
physiochemical identification | A red colour develops in the aqueous layer | ||||
TESTS | Other species of Rhamnus; anthrones(Thin-layer chromatography) | barbaloin | |||
Foreign matter | ≤1% | ||||
Loss on drying | ≤10.0% | ||||
Total ash | ≤7.0% | ||||
ASSAY | Content | ≥8.0 % of hydroxyanthracene glycosides of which minimum 60 % consists of cascarosides, both expressed as cascaroside A(dried drug) | |||
70 | Cascara Tablets | IDENTIFICATION | Thin-layer chromatography | barbaloin,emodin | |
TESTS | Disintegration | Comply with the requirements stated under Tablets but for sugar-coated tablets the time ≤ 120 minutes | |||
ASSAY | Content | Content of total hydroxyanthracene derivatives 17.0 to 23.0 mg, of which≥ 60% consists of cascarosides, both expressed as cascaroside A. | |||
71 | Cassia Oil | IDENTIFICATION | physiochemical identification | - | physiochemical identification |
Thin-layer chromatography | trans-cinnamic aldehyde | cinnamaldehyde | |||
Chromatographic profile(Examine the chromatograms obtained in the test) | The principal peaks in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with the reference solution. Eugenol may be absent from the chromatogram obtained with the test solution. | - | |||
TESTS | Relative density | 1.052 to 1.070 | 1.055-1.070 | ||
Refractive index | 1.600 to 1.614 | 1.602~1.614 | |||
Optical rotation | -1 to +1 | - | |||
Chromatographic profile(Gas chromatography) | "Determine the percentage Content of each of these components. The percentages are within the following ranges: — trans-cinnamic aldehyde: 70 % to 90 %; — cinnamyl acetate: 1.0 % to 6.0 %; — eugenol: ≤ 0.5 %; — trans-2-methoxycinnamaldehyde: 3.0 % to 15 %; — coumarin: 1.5 % to 4.0 %" | - | |||
Heavy metal | Water layer and oil layer shall not change color | ||||
Insoluble substance in ethanol | present clear liquid | ||||
ASSAY | Content | cinnamaldehyde,≥75.0% | |||
72 | Centaury | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | rutoside trihydrate, swertiamarin | ||||
TESTS | Foreign matter | ≤3% | |||
Bitterness value | ≥2000 | ||||
Loss on drying | ≤10.0% | ||||
Total ash | ≤6.0% | ||||
ASSAY | |||||
73 | Centella | IDENTIFICATION | Microscopic examination | powder | transverse section,leaf surface view |
Thin-layer chromatography | entella dry extract | asiaticoside,madecassoside | |||
TESTS | Bacopa monnieri L.(Thin-layer chromatography) | entella dry extract | - | ||
Foreign matter | ≤5% of underground organs and ≤2% of other foreign matter | - | |||
Loss on drying | ≤12.0% | ≤12.0% | |||
Total ash | ≤12.0% | ≤13.0% | |||
Ash insoluble in hydrochloric acid | ≤2.0% | ≤3.5% | |||
ASSAY | Ethanol-soluble extractive | - | ≥2.5% | ||
Content | ≥ 6.0 % of total triterpenoid derivatives, expressed as asiaticoside (dried drug) | sum of asiaticoside and madecassoside,≥0.80% | |||
74 | Ceylon Cinnamon Bark Oil | IDENTIFICATION | Thin-layer chromatography | trans-cinnamic aldehyde,eugenol , linalol,β-caryophyllene | |
Chromatographic profile(Examine the chromatograms obtained in the test) | The principal peaks in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with the reference solution. Safrole, coumarin and cineole may be absent from the chromatogram obtained with the test solution. | ||||
TESTS | Relative density | 1.000 to 1.030 | |||
Refractive index | 1.572 to 1.591 | ||||
Optical rotation | -2 to +1 | ||||
Chromatographic profile(Gas chromatography) | "Determine the percentage Content of each of these components. The percentages are within the following ranges: — cineole: ≤ 3.0 %; — linalol: 1.0 % to 6.0 %; — β-caryophyllene: 1.0 % to 4.0 %; — safrole: ≤ 0.5 %; — trans-cinnamic aldehyde: 55 % to 75 %; — eugenol: ≤ 7.5 %; — coumarin: ≤ 0.5 %; — trans-2-methoxycinnamaldehyde: 0.1 % to 1.0 %; — benzyl benzoate: ≤ 1.0 %." | ||||
ASSAY | |||||
75 | Ceylon Cinnamon Leaf Oil | IDENTIFICATION | Thin-layer chromatography | trans-cinnamic aldehyde,eugenol , linalol,β-caryophyllene | |
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. The peaks corresponding to cineole, safrole, trans-cinnamic aldehyde, cinnamyl acetate and coumarin may be absent in the chromatogram obtained with the test solution. | ||||
TESTS | Relative density | 1.030 to 1.059 | |||
Refractive index | 1.527 to 1.540 | ||||
Optical rotation | -2.5 to +2.0 | ||||
Chromatographic profile(Gas chromatography) | "The percentages are within the following ranges: — cineole: ≤ 1.0 %, — linalol: 1.5 % to 3.5 %, — β-caryophyllene: 1.5 % to 7.0 %, — safrole: ≤ 3.0 %, — trans-cinnamic aldehyde: ≤ 3.0 %, — cinnamyl acetate: ≤ 2.0 %, — eugenol: 70 % to 85 %, — coumarin: ≤ 1.0 %." | ||||
ASSAY | |||||
76 | Chaenomeles Fruit | IDENTIFICATION | Microscopic examination | powder | powder |
High-performance thin-layer chromatography | oleanolic acid,β-sitosterol | reference drug, ursolic acid | |||
TESTS | Loss on drying | ≤14.0% | ≤15.0% | ||
Total ash | ≤5.0% | ≤5.0% | |||
acidity | - | pH,3.0~4.0 | |||
ASSAY | Content | ≥ 0.50% for the sum of oleanolic acid and ursolic acid, expressed as ursolic acid (dried drug). | sum of oleanolic acid and ursolic acid ,≥0.50% | ||
77 | Chamomile Flowers | IDENTIFICATION | Microscopic examination | powder | |
High-performance thin-layer chromatography | chlorogenic acid, apigenin 7-glucoside | ||||
TESTS | Diameter of the flower-heads | ≤ 3% of flower-heads have a diameter smaller than 8 mm | |||
Deteriorated flower-heads | Brown or darkened flower-heads are absent | ||||
Loss on drying | ≤11.0% | ||||
Total ash | ≤8.0% | ||||
ASSAY | Content | ≥7 mL/kg of essential oil (dried drug) | |||
78 | Chinese Goldthread Rhizome | IDENTIFICATION | Microscopic examination | Powder | transverse section |
Thin-layer chromatography | berberine chloride, palmatine | reference drug,berberine hydrochloride | |||
TESTS | Foreign matter | ≤5% of fragments of roots and leaves and ≤ 3% of other foreign matter | - | ||
Loss on drying | ≤10.0% | ≤14.0% | |||
Total ash | ≤5.0% | ≤5.0% | |||
Ash insoluble in hydrochloric acid | ≤2.5% | - | |||
ASSAY | Ethanol-soluble extractive | - | ≥15.0% | ||
Content | ≥5.0% of berberine (dried drug) | "Coptis chinensis: ≥5.5% of berberine, ≥0.80% of epiberberine,≥1.6% of coptisine,≥1.5% of palmatine,expressed as berberine hydrochloride (dried drug). Coptis deltoidea: ≥4.5% of berberine, expressed as berberine hydrochloride (dried drug). Coptis teeta:≥7.0% of berberine, expressed as berberine hydrochloride (dried drug)." | |||
79 | Chinese Motherwort | IDENTIFICATION | Microscopic examination | powder | transection |
High-performance thin-layer chromatography | hyperoside,rutoside | stachydrine | |||
TESTS | Foreign matter | ≤5.0% | - | ||
Loss on drying | ≤10.0% | ≤13.0% | |||
Total ash | ≤11.0% | ≤11.0% | |||
ASSAY | Water-soluble extractive | - | ≥15.0% | ||
Content | Minimum 0.2 per cent of flavonoids, expressed as hyperoside (C21H20O12; Mr 464.4) | stachydrine≥0.50%;Leonurine hydrochloride≥0.050% | |||
80 | Cinchona Bark | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | quinine,quinidine,cinchonine,inchonidine | ||||
TESTS | Total ash | ≤6.0% | |||
Loss on drying | ≤10.0% | ||||
ASSAY | Content | ≥6.5% of total alkaloids, of which 30% to 60 % consists of quinine-type alkaloids (dried drug) |