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| NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
| 21 | Anise Oil | IDENTIFICATION | Thin-layer chromatography | linalol， anisaldehyde， anethole | |
| chromatographic profile | "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（linalol， anisaldehyde， anethole）." | ||||
| TESTS | Relative density | 0.980 to 0.990 | |||
| Refractive index | 1.552 to 1.561 | ||||
| Freezing point | 15 °C to 19 °C | ||||
| Fenchone（Gas chromatography） | fenchone: ≤ 0.01%. | ||||
| Foeniculin（Gas chromatography） | foeniculin: ≤ 0.01%. | ||||
| Fatty oils and resinified essential oils | It complies with the test for fatty oils and resinified essential oils | ||||
| ASSAY | Chromatographic profile | "Determine the percentage content of these components. The percentages are within the following ranges:— linalol: ≤ 1.5%, — estragole: 0.5% to 5.0%, — α-terpineol: ≤ 1.2%, — cis-anethole: 0.1% to 0.4%, — trans-anethole: 87% to 94%, — anisaldehyde: 0.1% to 1.4%, — pseudoisoeugenyl 2-methylbutyrate: 0.3% to 2.0%." | |||
| 22 | Arnica Flower | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | caffeic acid ，chlorogenic acid ，rutoside trihydrate | ||||
| TESTS | Foreign matter | ≤5.0% | |||
| Calendula officinalis L. - Heterotheca inuloides Cass（Thin-layer chromatography） | caffeic acid ，chlorogenic acid ，rutoside trihydrate | ||||
| Loss on drying | ≤10.0% | ||||
| Total ash | ≤10.0% | ||||
| ASSAY | Content | Minimum 0.40% m/m of total sesquiterpene lactones, expressed as dihydrohelenalin tiglate (dried drug) | |||
| 23 | Arnica Tincture | IDENTIFICATION | Thin-layer chromatography | caffeic acid ，chlorogenic acid ，rutoside trihydrate | |
| TESTS | Calendula officinalis - Heterotheca inuloides（Thin-layer chromatography） | caffeic acid ，chlorogenic acid ，rutoside trihydrate | |||
| Ethanol | The final ethanol concentration≥90%of that of the initial extraction solvent | ||||
| Methanol and 2-propanol | ≤0.05% V/V of methanol and≤0.05%V/V of 2-propanol. | ||||
| Dry residue | ≥1.7% | ||||
| ASSAY | Content | Minimum 0.04% of sesquiterpene lactones expressed as dihydrohelenalin tiglate | |||
| 24 | Aromatic Cardamom Tincture | IDENTIFICATION | Thin-layer chromatography | caffeic acid ，chlorogenic acid ，rutoside trihydrate | |
| TESTS | Calendula officinalis - Heterotheca inuloides（Thin-layer chromatography） | caffeic acid ，chlorogenic acid ，rutoside trihydrate | |||
| Ethanol | The final ethanol concentration≥90%of that of the initial extraction solvent | ||||
| Methanol and 2-propanol | ≤0.05% V/V of methanol and≤0.05%V/V of 2-propanol. | ||||
| Dry residue | ≥1.7% | ||||
| ASSAY | Content | Minimum 0.04% of sesquiterpene lactones expressed as dihydrohelenalin tiglate | |||
| 25 | Artichoke Leaf | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | Luteolin-7-glucoside，Chlorogenic acid | ||||
| TESTS | Total ash | ≤20.0% | |||
| Loss on drying | ≤12.0% | ||||
| ASSAY | Content | Minimum 0.7% of chlorogenic acid | |||
| 26 | Artichoke Leaf Dry Extra | IDENTIFICATION | Thin-layer chromatography | Luteolin-7-glucoside，Chlorogenic acid | |
| TESTS | Total ash | ≤30.0% | |||
| Loss on drying | ≤6.0% | ||||
| ASSAY | Content | Minimum 0.6% of chlorogenic acid | |||
| 27 | Ash Leaf | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | Chlorogenic acid，Rutoside | ||||
| TESTS | Foreign matter | ≤3.0% of stems and ≤ 2.0% of other foreign matter. | |||
| Fraxinus ornus（Thin-layer chromatography） | rutoside trihydrate， chlorogenic acid | ||||
| Loss on drying | ≤10.0% | ||||
| Total ash | ≤12.0% | ||||
| ASSAY | Content | Minimum 2.5% of total hydroxycinnamic acid derivatives, expressed as chlorogenic acid | |||
| 28 | Astragalus Mongholicus Root | IDENTIFICATION | Microscopic examination | powder | powder，transverse section |
| Thin-layer chromatography | Daidzein，Daidzin | astragaloside，reference drug | |||
| TESTS | Foreign matter | ≤5.0% | - | ||
| Loss on drying | ≤10.0% | ≤10.0% | |||
| Total ash | ≤5.0% | ≤5.0% | |||
| Ash insoluble in hydrochloric acid | ≤1.0% | - | |||
| Pb, Cr, As, Hg and Cu | - | Pb ≤5ppm, Cr≤1ppm, As2ppm, Hg ≤0.2ppm, Cu≤20ppm | |||
| Organochlorine pesticides residue | - | quintozene≤0.1ppm | |||
| ASSAY | Water-soluble extractives | - | ≥17.0% | ||
| Content | Minimum 0.040% of astragaloside IV | astragaloside≥0.080%，Calycoflavone glucoside≥0.020% | |||
| 29 | Atractylodes Lancea Rhizome | IDENTIFICATION | Microscopic examination | powder | powder |
| Thin-layer chromatography | β-Caryophyllene，Bornyl acetate | Atractydin，reference drug | |||
| TESTS | Atractylodes macrocephala（Thin-layer chromatography） | β-Caryophyllene，Bornyl acetate | - | ||
| Water | ≤100ml/kg | - | |||
| Total ash | ≤7.0% | ≤7.0% | |||
| Ash insoluble in hydrochloric acid | ≤1.0% | - | |||
| Loss on drying | - | ≤13.0% | |||
| ASSAY | Content | Minimum 14 mL/kg of essential oil | Atractydin≥0.30% | ||
| 30 | Aucklandia Root | IDENTIFICATION | Microscopic examination | powder | powder |
| Thin-layer chromatography | Dehydrocostus lactone，Costunolide | Dehydrocostus lactone，Costunolide | |||
| TESTS | Vladimiria souliei (Franch.) Y. Ling and Inula helenium L.（Thin-layer chromatography） | Dehydrocostus lactone，Costunolide | - | ||
| Aristolochic acids | 2.8.21, Method A，It complies with the test. | - | |||
| Loss on drying | ≤12.0% | ||||
| Total ash | ≤4.0% | ||||
| ASSAY | Content | Minimum 0.6% of costunolide and minimum 1.8% for the sum of costunolide and dehydrocostus lactone | sum of dehydrocostus Lactone，costunolide ≥1.8% | ||
| 31 | Azadirachta Indica Leaf | IDENTIFICATION | Microscopic examination | powder | - |
| Thin-layer chromatography | azadirachtin, salannin， β-sitosterol | - | |||
| TESTS | Foreign matter | ≤2% | - | ||
| Loss on drying | ≤10.0% | - | |||
| Ash | ≤10.0% | - | |||
| ASSAY | Water-soluble extractive | ≥20.0% | - | ||
| Content | It contains ≥ 1.0% of tetranortriterpinoids, expressed as salannin, calculated with reference to the dried drug. | - | |||
| 32 | Bacopa Monnieri | IDENTIFICATION | Microscopic examination | powder | - |
| Thin-layer chromatography | bacopaside I，bacopaside II | - | |||
| TESTS | Foreign matter | ≤1.0% | - | ||
| Loss on drying | ≤11.0% | - | |||
| Ash | ≤13.0% | - | |||
| ASSAY | Water-soluble extractive | ≥15.0% | - | ||
| Content | It contains ≥ 1.0% w/w of bacopa saponins, expressed as bacopaside II calculated with reference to the dried drug. | - | |||
| 33 | Barbados Aloes | IDENTIFICATION | physiochemical identification | - | physiochemical identification |
| Thin-layer chromatography | Aloe emodin，Barbaloin | Aloin | |||
| TESTS | Loss on drying | ≤12.0% | ≤12.0% | ||
| Total Ash | ≤2.0% | ≤4.0% | |||
| Cape aloes(Thin-layer chromatography) | Aloe emodin，Barbaloin | - | |||
| ASSAY | Content | Minimum 28.0% of hydroxyanthracene derivatives, expressed as barbaloin (dried drug) | Aloin ≥16.0% for Aloe barbadensis, and ≥6.0% for Aloe ferox | ||
| 34 | Barbary Wolfberry Fruit | IDENTIFICATION | Microscopic examination | powder | powder |
| Thin-layer chromatography | scopoletin，rutoside trihydrate | reference drug | |||
| TESTS | Loss on drying | ≤11.0% | ≤13.0% | ||
| Total Ash | ≤5.0% | ≤5.0% | |||
| Pb, Cr, As, Hg and Cu | - | Pb ≤5ppm, Cr≤1ppm, As2ppm, Hg ≤0.2ppm, Cu≤20ppm | |||
| ASSAY | Extractable matter（water-soluble extractives） | ≥55.0% | ≥55.0% | ||
| Content | - | "—minimum 1.8% of lycium barbarum polysaccharide，expressed as glucose； —minimum 0.50% of glycine betaine" | |||
| 35 | Bearberry Leaf | IDENTIFICATION | Microscopic examination | powder | - |
| Thin-layer chromatography | arbutin，gallic acid | - | |||
| TESTS | Foreign matter | ≤5% of stems and ≤ 3% of other foreign matter. | - | ||
| Loss on drying | ≤10.0% | - | |||
| Total Ash | ≤5.0% | - | |||
| ASSAY | Content | ≥ 7.0% of anhydrous arbutin(dried drug) | - | ||
| 36 | Belamcanda Chinensis Rhizome | IDENTIFICATION | Microscopic examination | powder | powder，transverse section |
| Thin-layer chromatography | Coumarin，Irisflorentin | reference drug | |||
| TESTS | Iris tectorum Maxim | Coumarin，Irisflorentin | - | ||
| Loss on drying | ≤10.0% | ≤10.0% | |||
| Total Ash | ≤7.0% | ≤7.0% | |||
| Ash insoluble in hydrochloric acid | ≤1.0% | - | |||
| ASSAY | Ethanol-soluble extractive | - | ≥18.0% | ||
| Content | ≥0.10 % of irisflorentin(dried drug) | minimum 0.10% of Irisflorentin | |||
| 37 | Belladonna Leaf | IDENTIFICATION | Microscopic examination | powder | powder |
| physiochemical identification | A deep violet colour develops | Identification of residue xenotropane alkaloids (General rule 0301) | |||
| Thin-layer chromatography | hyoscyamine sulfate， hyoscine hydrobromide | Atropine Sulfate，scopolamine hydrobromide | |||
| TESTS | Foreign matter | ≤ 3% of stems with a diameter greater than 5 mm. | Leaves of abnormal color (yellowish brown or nearly black) not more than 4%，≤ 3% of stems with a diameter greater than 1cm | ||
| Loss on drying | - | ≤13.0% | |||
| Total Ash | ≤16.0% | - | |||
| Ash insoluble in hydrochloric acid | ≤4.0% | - | |||
| ASSAY | Content | "≥ 0.30% of total alkaloids, expressed as hyoscyamine(dried drug). The alkaloids consist mainly of hyoscyamine together with small quantities of hyoscine (scopolamine)." | minimum 0.30% of alkaloid，expressed as hyoscyamine | ||
| 38 | Belladonna Tincture | IDENTIFICATION | Thin-layer chromatography | chlorogenic acid，rutoside trihydrate | hyoscyamine sulfate,atropine sulfate |
| TESTS | Atropine（Thin-layer chromatography） | hyoscyamine sulfate， hyoscine hydrobromide | atropine sulfate | ||
| Ethanol | 64% V/V to 69%V/V | - | |||
| Loss on drying | - | ≤5.0% | |||
| characteristic spectrum | - | Scopoletin | |||
| ASSAY | Content | "0.027%to 0.033% of total alkaloids, calculated as hyoscyamine. The alkaloids consist mainly of hyoscyamine together with small quantities of hyoscine." | 8.3~11.0mg of total alkaloids per gram, calculated as hyoscyamine sulfate. Minimum 0.55mg of Scopoletin per gram. | ||
| 40 | Berberis Aristata | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | berberine chloride，palmatine chloride | ||||
| TESTS | D-Tetrahydropalmatine | palmatine chloride，berberine chloride | |||
| Loss on drying | ≤10.0% | ||||
| Total ash | ≤3.0% | ||||
| ASSAY | Content | It contains ≥ 1.4% of berberine , calculated with reference to the dried material. |