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NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
195 | Largehead Atractylodes Rhizome | IDENTIFICATION | Microscopic examination | ||
Thin-layer chromatography | β-Caryophyllene,Bornyl acetate | ||||
physiochemical identification | a red or reddish-purple colour develops and persists | ||||
TESTS | Atractylodes lancea(Thin-layer chromatography) | β-caryophyllene,bornyl acetate | |||
Water | ≤ 100 mL/kg | ||||
Total ash | ≤ 5.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 1.0 % | ||||
Loss on drying | |||||
sulfur dioxide residue | |||||
ASSAY | chromaticity | ||||
Ethanol-soluble extractive | |||||
Content | ≥ 9 mL/kg of essential oil (anhydrous drug) | ||||
196 | Lavender Flower | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | Linalyl acetate,1,8-Cineole,Linalol | ||||
Gas chromatography | "The 5 principal peaks in the chromatogram obtained with the test solution are similar in retention time to the corresponding peaks in the chromatogram obtained with the reference solution; the 2 main peaks are due to linalol and linalyl acetate. (reference solution:camphor,α-terpineol ,limonene,cineole,linalol ,inalyl acetate) " | ||||
TESTS | Foreign matter | ≤ 3 % of stems and ≤ 2 % of other foreign matter. | |||
Lavandin flower (Lavandula x intermedia Emeric ex Loisel)(Thin-layer chromatography) | Linalyl acetate,1,8-Cineole,Linalol | ||||
Other species and varieties of lavender(Gas chromatography) | Limit:camphor: ≤ 1 % | ||||
Water | ≤ 100 mL/kg, determined on 20.0 g | ||||
Total ash | ≤ 9.0 % | ||||
ASSAY | Content | ≥ 13 mL/kg of essential oil (anhydrous drug) | |||
197 | Lavender Oil | IDENTIFICATION | Thin-layer chromatography | Linalyl acetate,1,8-Cineole,Linalol | |
Chromatographic profile | The essential oil to be examined complies with the limits of the test for chromatographic profile. | ||||
TESTS | Relative density | 0.878 to 0.892 | |||
Refractive index | 1.455 to 1.466 | ||||
Optical rotation | -12.5 to -6.0 | ||||
Acid value | ≤ 1.0 | ||||
Chromatographic profile | "Determine the percentage Content of each of the following components. The percentages are within the following ranges: — limonene: ≤ 1.0 %; — 1,8-cineole: ≤ 2.5 %; — 3-octanone: 0.1 % to 5.0 %;— camphor: ≤ 1.2 %; — linalol: 20.0 % to 45.0 %; — linalyl acetate: 25.0 % to 47.0 %; — terpinen-4-ol: 0.1 % to 8.0 %; — lavandulyl acetate: ≥ 0.2 %; — lavandulol: ≥ 0.1 %; — α-terpineol: ≤ 2.0 %; — reporting threshold: the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 %)" | ||||
Chiral purity | "Limits: — (S)-linalol: ≤ 12 %; — (S)-linalyl acetate: ≤ 1 %" | ||||
ASSAY | |||||
198 | Lemon Balm | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | citronellal,citral | ||||
TESTS | Foreign matter | ≤ 10 % of stems with a diameter greater than 1 mm and ≤ 2 % of other foreign matter, determined on 20 g | |||
Loss on drying | ≤ 10.0 % | ||||
Total ash | ≤ 12.0 % | ||||
ASSAY | Content | ≥ 1.0 % of rosmarinic acid (C18H16O8; Mr 360.3) (dried drug) | |||
199 | Lemon Balm Dry Extract | IDENTIFICATION | Thin-layer chromatography | hyperoside,rutoside trihydrate,rosmarinic acid | |
TESTS | Loss on drying | ≤ 6.0 % | |||
ASSAY | Content | ≥ 2.0 % of rosmarinic acid (C18H16O8; Mr 360.3) (dried extract). | |||
200 | Lemon Oil | IDENTIFICATION | Thin-layer chromatography | citropten,citral | |
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(β-pinene, sabinene, limonene,γ-terpinene,β-caryophyllene,citral,α-terpineol,neryl acetate ,geranyl acetate) | ||||
TESTS | Relative density | 0.850 to 0.858 | |||
Refractive index | 1.473 to 1.476 | ||||
Optical rotation | +57 to +70 | ||||
Absorbance | The value C - D is 0.20 to 0.96 and for Italiantype lemon oil it is not less than 0.45 | ||||
Chromatographic profile | "Determine the percentage Content of these components. The percentages are within the following ranges: — β-pinene: 7.0 % to 17.0 %, — sabinene: 1.0 % to 3.0 %, — limonene: 56.0 % to 78.0 %, — γ-terpinene: 6.0 % to 12.0 %, — β-caryophyllene: ≤ 0.5 %, — neral: 0.3 % to 1.5 %, — α-terpineol: ≤ 0.6 %, — neryl acetate: 0.2 % to 0.9 %, — geranial: 0.5 % to 2.3 %, — geranyl acetate: 0.1 % to 0.8 % " | ||||
Fatty oils and resinified essential oils | It complies with the test for fatty oils and resinified essential oils | ||||
ASSAY | Residue on evaporation | 1.8 % to 3.6 % after heating on the water-bath for 4 h | |||
203 | Lemon Verbena Leaf | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | arbutin,Rutoside | ||||
TESTS | Foreign matter | ≤ 10 % of stems with a diameter greater than 1 mm and ≤ 2 % of other foreign matter, determined on 20 g | |||
Verbena officinalis(Thin-layer chromatography) | arbutin,rutoside trihydrate | ||||
Loss on drying | ≤ 10.0 % | ||||
Total ash | ≤ 13.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 3.5 % | ||||
ASSAY | Content | "— acteoside: ≥ 2.5 %, expressed as ferulic acid (dried drug); — essential oil: ≥ 3.0 mL/kg for the whole drug and ≥ 2.0 mL/kg for the fragmented drug (dried drug)." | |||
204 | Ligusticum Root and Rhizome | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | (Z)-Ligustilide,Osthole,Imperatorin | ||||
TESTS | Foreign matter | ≤ 3 %, determined on 50 g | |||
Officinal species of Angelica and Levisticum(Thin-layer chromatography) | (Z)-Ligustilide,Osthole,Imperatorin | ||||
Loss on drying | ≤ 12.0 % | ||||
Total ash | ≤ 6.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 2.0 % | ||||
ASSAY | Ethanol-soluble extractive | - | |||
Content | ≥ 5.0 mL/kg of essential oil (dried drug) | ||||
205 | Lime Flower | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | caffeic acid ,hyperoside ,rutoside trihydrate | ||||
TESTS | Foreign matter | ≤ 2 %, determined on 30 g. There are no inflorescences with a bract bearing at the abaxial face stellate, five- to eight-rayed trichomes and flowers having an apparent double corolla by transformation of five stamens into petal-like staminoids and having a pistil which is not lobular nor indented. Hexamerous flowers occur only occasionally (Tilia americana L., Tilia tomentosa Moench) | |||
Loss on drying | ≤ 12.0 % | ||||
Total ash | ≤ 8.0 % | ||||
ASSAY | |||||
206 | Linseed | IDENTIFICATION | Microscopic examination | powder | |
physiochemical identification | - | ||||
TESTS | Foreign matter | ≤ 10 % of seeds with a dull coat and ≤ 1.5 % of other foreign matter | |||
Swelling index | Minimum 4 | ||||
Cadmium | ≤ 0.5 ppm | ||||
Loss on drying | ≤ 8.0 % | ||||
Total ash | ≤ 5.0 % | ||||
ASSAY | Content | - | |||
207 | Liquorice | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | glycyrrhetic acid,thymol | ||||
TESTS | Total ash | ≤ 10.0 % for the unpeeled drug and ≤ 6.0 % for the peeled drug | |||
Acid-insoluble ash | ≤ 2.0 % for the unpeeled drug and ≤ 0.5 % for the peeled drug | ||||
Loss on drying | ≤ 10.0 % | ||||
Ochratoxin A | ≤ 20 µg per kilogram of herbal drug. | ||||
ASSAY | Content | Minimum 4.0 % of 18β-glycyrrhizic acid (dried drug). | |||
208 | Liquorice Dry Extract for Flavouring Purposes | IDENTIFICATION | Thin-layer chromatography | glycyrrhetic acid,thymol | |
TESTS | Loss on drying | ≤ 7.0 % | |||
Ochratoxin A | ≤ 80 µg per kilogram of extract | ||||
ASSAY | Content | 5.0 % to 7.0 % of 18β-glycyrrhizic acid (dried extract) | |||
209 | Liquorice Liquid Extract | IDENTIFICATION | high performance thin-layer chromatography | hyperoside, rutin,hyperoside, chlorogenic acid , 18β-glycyrrhizic acid | |
TESTS | Ethanol | 16 to 20 % v/v | |||
Methanol | ≤ 0.05% v/v | ||||
Ochratoxin A | ≤ 20 ppb | ||||
ASSAY | |||||
210 | Liquorice Root for use in TCM | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | glycyrrhetic acid,thymol | ||||
TESTS | Loss on drying | ≤ 7.0% | |||
Acid-insoluble ash | ≤ 2.0% | ||||
Loss on drying | ≤ 12.0% | ||||
Ochratoxin A | ≤ 20 ppb | ||||
Pb, Cr, As, Hg and Cu | |||||
Organochlorine pesticides residue | |||||
ASSAY | Content | It contains not less than 2.0% of glycyrrhizic acid , calculated with reference to the dried material | |||
211 | Long Pepper | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | borneol ,piperine | ||||
physiochemical identification | - | ||||
TESTS | Foreign matter | ≤ 3 % | |||
Loss on drying | ≤ 11.0 % | ||||
Total ash | ≤ 5.0 % | ||||
ASSAY | Content | "— essential oil: minimum 6.0 mL/kg (dried drug); — piperine : minimum 3.0 % (dried drug)" | |||
212 | Loosestrife | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | chlorogenic acid ,hyperoside , rutoside trihydrate, vitexin | ||||
physiochemical identification | - | ||||
TESTS | Loss on drying | ≤ 12.0 % | |||
Total ash | ≤ 7.0 % | ||||
ASSAY | Content | Minimum 5.0 % of tannins, expressed as pyrogallol (dried drug) | |||
213 | Lovage Root | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | (Z)-Ligustilide,Osthole,Imperatorin | ||||
TESTS | Species of Angelica and Ligusticum described in the European Pharmacopoeia(Thin-layer chromatography ) | (Z)-Ligustilide,Osthole,Imperatorin | |||
Foreign matter | ≤ 3 % | ||||
Loss on drying | ≤ 12.0 % | ||||
Total ash | ≤ 8.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 2.0 % | ||||
ASSAY | Content | "Essential oil Content: — for the whole drug, minimum 4.0 mL/kg (dried drug); — for the cut drug, minimum 3.0 mL/kg (dried drug)." | |||
214 | Lycopus Lucidus Herb | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | luteolin,ursolic acid | ||||
TESTS | Loss on drying | ≤ 10.0 % | |||
Total ash | ≤ 8.0 % | ||||
ASSAY | Ethanol-soluble extractive | - | |||
Content | Minimum 0.15 % of rosmarinic acid (dried drug) |