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NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
1 | Abelmoschus Flower | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | powder | allicin | |||
TESTS | Loss on drying | ≤12% | - | ||
Total ash | ≤8% | ≤13% | |||
Ash insoluble in hydrochloric acid | - | ≤2% | |||
Extractable matter | - | ||||
ASSAY | Content | - | ≥0.15% | ||
2 | Acanthopanax Bark | IDENTIFICATION | Microscopic examination | powder,transverse section | powder,transverse section |
Thin-layer chromatography | thymol, borneol | Isokauri acid,reference drug | |||
TESTS | Periploca sepium(Thin-layer chromatography) | thymol, borneol | - | ||
Acanthopanax giraldii(Thin-layer chromatography) | Morphological identification | - | |||
Loss on drying | ≤12% | ≤12% | |||
Total ash | ≤12% | ≤11.5% | |||
Ash insoluble in hydrochloric acid | ≤2% | ≤3.5% | |||
Extractable matter | ≥16% | ≥10.5% | |||
ASSAY | |||||
3 | Achyranthes Bidentata Root | IDENTIFICATION | Microscopic examination | powder,transverse section | transverse section |
Thin-layer chromatography | β-ecdysterone,ginsenoside Ro | β-ecdysterone,ginsenoside Ro | |||
TESTS | Loss on drying | ≤15% | ≤15.0% | ||
Total ash | ≤9% | ≤9.0% | |||
Ash insoluble in hydrochloric acid | ≤1.5% | - | |||
sulfur dioxide residue | - | ≤400ppm | |||
ASSAY | Ethanol-soluble extractive | - | ≥6.5% | ||
Content | Minimum 0.1% of total sterones, expressed as β-ecdysterone | β-ecdysterone,≥0.030% | |||
5 | Agnus Castus Fruit | IDENTIFICATION | Thin-layer chromatography | caffeic acid,homoorientin | |
TESTS | |||||
ASSAY | Content | Minimum 0.1% of casticin | |||
6 | Agnus Castus Fruit Dry Extract | Thin-layer chromatography | caffeic acid,homoorientin | ||
TESTS | |||||
ASSAY | - | Minimum 0.1% of casticin | |||
7 | Agrimony | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | Isoquercitroside,Rutoside | ||||
TESTS | Total ash | ≤10.0% | |||
Loss on drying | ≤10.0% | ||||
ASSAY | Content | Minimum 2.0% of tannins, expressed as pyrogallol | |||
8 | Akebia Stem | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | Oleanolic acid,Hederagenin | Xylopharyngoside B | |||
TESTS | Total ash | ≤6.5% | ≤6.5% | ||
Loss on drying | ≤10.0% | ≤10.0% | |||
Aristolochic acids | It complies with the test. | - | |||
ASSAY | Content | Minimum 0.15% of oleanolic acid | Xylopharyngoside B,≥0.15% | ||
9 | Alchemilla | IDENTIFICATION | Microscopic examination | powder,transverse section | |
Thin-layer chromatography | Caffeic acid,Chlorogenic acid | ||||
TESTS | Total ash | ≤12.0% | |||
Loss on drying | ≤10.0% | ||||
ASSAY | Content | Minimum 6.0% of tannins, expressed as pyrogallol | |||
10 | Alisma Plantago-Aquatica | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | β -sitosterol,Alisol B 23 acetate | Alisol B 23 acetate,Alisol C 23 acetate | |||
TESTS | Foreign matter | ≤2.0% | - | ||
Loss on drying | ≤9.0% | ≤14.0% | |||
Total ash | ≤3.0% | ≤5.0% | |||
Ash insoluble in hydrochloric acid | ≤0.5% | - | |||
Ethanol-soluble extractive | - | ≥10.0% | |||
ASSAY | Content | - | sum of alisol B 23 acetate and alisol C 23 acetate,≥0.10% | ||
12 | Amomum Fruit | IDENTIFICATION | Microscopic examination | powder,transverse section | |
Thin-layer chromatography | bornyl acetate, borneol R | ||||
TESTS | Water | ≤120 mL/kg | |||
Loss on drying | - | ||||
Total ash | ≤9.0% | ||||
Ash insoluble in hydrochloric acid | - | ||||
ASSAY | Content | "— essential oil: minimum 30 mL/kg for A. villosum (anhydrous drug) and minimum 10 mL/kg for A. longiligulare (anhydrous drug); — bornyl acetate: minimum 30.0% of the essential oil." | |||
13 | Andrographis Herb | IDENTIFICATION | Microscopic examination | powder,transverse section,surface view | transverse section,surface view |
Thin-layer chromatography | 14-deoxy-11,12-didehydroandrographolide ,andrographolide | Andrographolide,reference drug | |||
TESTS | Loss on drying | ≤10.0% | ≤13.0% | ||
Total ash | ≤12.0% | - | |||
leaf | - | ≥30% | |||
Ethanol-soluble extractive | - | ≥8.0% | |||
ASSAY | Content | Minimum 0.80% of the sum of andrographolide and 14-deoxy-11,12-didehydroandrographolide | sum of andrographolide, neoandrographolide,14-deoxyandrographolide and Dehydroandrographolide ≥1.5% | ||
14 | Anemarrhena Asphodeloides Rhizome | IDENTIFICATION | Microscopic examination | powder | powder |
Thin-layer chromatography | Aescin,Arbutin | mangiferin,timosaponin | |||
TESTS | Loss on drying | ≤11.0% | ≤12.0% | ||
Total ash | ≤6.0% | ≤9.0% | |||
Ash insoluble in hydrochloric acid | ≤1.0% | ≤4.0% | |||
ASSAY | Content | Minimum 0.5% of mangiferin | mangiferin≥0.70%,timosaponin BII ≥3.0% | ||
15 | Anethum Graveolens Sowa Fruit | IDENTIFICATION | Microscopic examination | powder,transverse section,surface view | |
Thin-layer chromatography | carvone, dillapiole | ||||
TESTS | Apiole | Carry out the method for gas chromatography,In the chromatogram obtained with solution (1) the area of any peak due to apiole is ≤ the area of the peak due to apiole in the chromatogram obtained with solution (3). | |||
Water | ≤10.0% v/w | ||||
Total ash | ≤8.0% | ||||
Chromatographic profile | "Limits: — limonene: 15.0 to 28.0%, — sum of dihydrocarvone isomers 1 and 2: 5.0 to 30.0%, — carvone: 20.0 to 45.0%, — dillapiole: 15.0 to 35.0%" | ||||
ASSAY | Content | It contains ≥ 3.0% v/w of essential oil calculated with reference to the anhydrous drug. | |||
16 | Angelica Archangelica Root | IDENTIFICATION | Microscopic examination | powder,transverse section | |
Thin-layer chromatography | (Z)-Ligustilide,Osthole,Imperatorin | ||||
TESTS | Other officinal species of Angelica, Levisticum and Ligusticum(Thin-layer chromatography) | imperatorin, (Z)-ligustilide,osthole | |||
Foreign matter | ≤5% | ||||
Loss on drying | ≤10.0% | ||||
Total ash | ≤10.0% | ||||
Ash insoluble in hydrochloric acid | ≤2.0% | ||||
ASSAY | Content | Minimum 2.0 mL/kg of essential oil (dried drug) | |||
17 | Angelica Dahurica Root | IDENTIFICATION | Microscopic examination | powder,transverse section | powder |
Thin-layer chromatography | (Z)-Ligustilide,Osthole,Imperatorin | imperatorin,isoimperatorin,reference drug | |||
TESTS | Other officinal species of Angelica, Levisticum and Ligusticum(Thin-layer chromatography) | (Z)-Ligustilide,Osthole,Imperatorin | - | ||
Loss on drying | ≤12.0% | ≤14.0% | |||
Total ash | ≤6.0% | ≤6.0% | |||
Ash insoluble in hydrochloric acid | ≤1.5% | - | |||
Pb, Cr, As, Hg and Cu | - | Pb ≤5ppm, Cr≤1ppm, As2ppm, Hg ≤0.2ppm, Cu≤20ppm | |||
Ethanol-soluble extractive | - | ≥15.0% | |||
ASSAY | Content | Minimum 0.08% of imperatorin | imperatorin≥0.080% | ||
18 | Angelica Pubescens Root | IDENTIFICATION | Microscopic examination | powder | transverse section |
Thin-layer chromatography | (Z)-Ligustilide,Osthole,Imperatorin | Columbianadin,Osthole,reference drug | |||
TESTS | Other officinal species of Angelica, Levisticum and Ligusticum(Thin-layer chromatography) | (Z)-Ligustilide,Osthole,Imperatorin | - | ||
Loss on drying | ≤10.0% | ≤10.0% | |||
Total ash | ≤8.0% | ≤3.0% | |||
Ash insoluble in hydrochloric acid | ≤3.0% | ||||
ASSAY | Content | Minimum 0.50% of osthole | Columbianadin≥0.080%,Osthole≥0.50% | ||
19 | Angelica Sinensis Root | IDENTIFICATION | Microscopic examination | powder | transverse section |
Thin-layer chromatography | linoleic acid,ferulic acid, Z-ligustilide | reference drug | |||
TESTS | Lovage root (Levisticum officinale)(gas chromatography) | Z-ligustilide,benzyl alcohol,(-)-carvone, octanoic acid ,3-propylidenephthalide | - | ||
Loss on drying | ≤12.0% | ≤15.0% | |||
Total ash | ≤7.0% | ≤7.0% | |||
Ash insoluble in hydrochloric acid | ≤2.0% | ≤2.0% | |||
Pb, Cr, As, Hg and Cu | - | Pb ≤5ppm, Cr≤1ppm, As2ppm, Hg ≤0.2ppm, Cu≤20ppm | |||
ASSAY | Ethanol-soluble extractive | ≥45.0% | ≥45.0% | ||
Content | It contains ≥ 0.1% of Z-ligustilide, calculated with reference to the dried material. | "— essential oil: :≥0.4%(ml/g) —ferulic acid:≥0.050%" | |||
20 | Aniseed | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | anethole, olive oil | ||||
TESTS | Water | ≤ 90 mL/kg | |||
Total ash | ≤12.0% | ||||
Ash insoluble in hydrochloric acid | ≤2.5% | ||||
ASSAY | Content | Minimum 20 mL/kg of essential oil (anhydrous drug). |