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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).
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