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NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
235 | Moutan Bark | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | paeoniflorin,paeonol | ||||
TESTS | Foreign matter | ≤ 1.0 % | |||
Loss on drying | ≤ 11.0 % | ||||
Total ash | ≤ 5.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 1.0 % | ||||
ASSAY | Ethanol-soluble extractive | - | |||
Content | "— paeonol : ≥ 2.2 % (dried drug); — paeoniflorin:≥ 1.1 % (dried drug)" | ||||
236 | Mullein Flower | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | caffeic acid,hyperoside,rutoside trihydrate | ||||
TESTS | Foreign matter | ≤ 5 % of brown petals and ≤ 2 % of fragments of the calyx and other foreign matter, determined on 20 g | |||
Loss on drying | ≤ 12.0 % | ||||
Total ash | ≤ 6.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 2.0 % | ||||
Swelling index | ≥ 9 | ||||
ASSAY | |||||
237 | Myrrh | IDENTIFICATION | Thin-layer chromatography | Anethole,Thymol | |
physiochemical identification | - | ||||
TESTS | Commiphora mukul(Thin-layer chromatography) | thymol,anethole | |||
Matter insoluble in ethanol | ≤ 75 % | ||||
Loss on drying | ≤ 15.0 % | ||||
Total ash | ≤ 7.0 % | ||||
Foreign matter | - | ||||
Ash insoluble in hydrochloric acid | - | ||||
ASSAY | Content | - | |||
238 | Myrrh Tincture | IDENTIFICATION | Microscopic examination | powder | |
TESTS | Ethanol | 82 % V/V to 88 % V/V | |||
Methanol and 2-propanol | ≤ 0.05 % V/V of methanol and ≤ 0.05 % V/V of 2-propanol | ||||
Dry residue | ≥ 4.0 % m/m | ||||
ASSAY | |||||
239 | Neroli Oil | IDENTIFICATION | Thin-layer chromatography | methyl anthranilate , linalyl acetate, linalol,bergapten | |
Examine the chromatograms obtained in the test for chromatographic profile | "The principal peaks in the chromatogram obtained with the test solution are similar in retention time to the principal peaks in the chromatogram obtained with the reference solution" | ||||
TESTS | Relative density | 0.863 to 0.880 | |||
Refractive index | 1.464 to 1.474 | ||||
Optical rotation | + 1.5° to + 11.5° | ||||
Acid value | ≤ 2.0 | ||||
Bergapten(Thin-layer chromatography ) | methyl anthranilate , linalyl acetate, linalol,bergapten | ||||
Chromatographic profile | "Limits: — β -pinene: 7.0 % to 17.0 %, — limonene: 9.0 % to 18.0 %, — linalol: 28.0 % to 44.0 %, — linalyl acetate: 2.0 % to 15.0 %, — α -terpineol: 2.0 % to 5.5 %, — neryl acetate: ≤ 2.5 %, — geranyl acetate: 1.0 % to 5.0 %, — trans-nerolidol: 1.0 % to 5.0 %, — methyl anthranilate: 0.1 % to 1.0 %, —(E,E)-farnesol: 0.8 % to 4.0 %, — disregard limit: area of the peak in the chromatogram obtained with reference solution (b)" | ||||
ASSAY | Content | "Limits: — (S)(+)-linalol: ≤ 30 %, — (S)(+)-linalyl acetate: ≤ 5 %." | |||
240 | Nettle Leaf | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | scopoletin ,chlorogenic acid | ||||
TESTS | Foreign matter | ≤ 5 % of stems and ≤ 5 % of other foreign matter (including inflorescences) | |||
Loss on drying | ≤ 12.0 % | ||||
Total ash | ≤ 20.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 4.0 % | ||||
ASSAY | Content | ≥ 0.3 % for the sum of caffeoylmalic acid and chlorogenic acid, expressed as chlorogenic acid (dried drug) | |||
241 | Nettle Root | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | scopoletin,arbutin,β-sitosterol | ||||
TESTS | Loss on drying | ≤ 12.0 % | |||
Lead | ≤ 7.0 ppm | ||||
Total ash | ≤ 12.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 4.0 % | ||||
ASSAY | Extractable matter | ≥ 7.0 % | |||
242 | Notoginseng Root | IDENTIFICATION | Microscopic examination | powder | |
Microscopic examination | aescin, arbutin | ||||
TESTS | Panax ginseng or Panax quinquefolium(Thin-layer chromatography) | aescin, arbutin | |||
Loss on drying | ≤ 12.0 % | ||||
Total ash | ≤ 6.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 1.0 % | ||||
Pb, Cr, As, Hg and Cu | - | ||||
ASSAY | Ethanol-soluble extractive | - | |||
Content | ≥ 3.8 % for the sum of ginsenosides Rg1 and Rb1(dried drug) | ||||
243 | Notopterygium Rhizome and Root | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | aescin, arbutin | ||||
TESTS | Panax ginseng or Panax quinquefolium(Thin-layer chromatography) | aescin, arbutin | |||
Loss on drying | ≤ 12.0 % | ||||
Total ash | ≤ 6.0 % | ||||
Ash insoluble in hydrochloric acid | ≤ 1.0 % | ||||
Pb, Cr, As, Hg and Cu | |||||
ASSAY | Ethanol-soluble extractive | - | |||
Content | ≥ 3.8 % for the sum of ginsenosides Rg1 and Rb1(dried drug) | ||||
244 | Nutmeg | IDENTIFICATION | Microscopic examination | powder | transverse section |
High performance thin-layer chromatography | myristicine,terpinen-4-ol, isoeugenol , isoeugenyl acetate | ||||
Thin-layer chromatography | - | reference drug | |||
TESTS | Water | ≤ 10.0% v/w | ≤ 10.0% v/w | ||
Foreign matter | Complies with the test for Foreign matter, Appendix XI D | ||||
Total ash | ≤ 3.0% | ||||
Loss on drying | - | ||||
Aflatoxin | - | ≤5ppb of Aflatoxin B1,≤10ppb of sum of Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2 | |||
ASSAY | Content | It contains not less than 5.0% v/w of essential oils, calculated with reference to the dried drug | It contains not less than 6.0% v/w of essential oils, calculated with reference to the dried drug.C20H22O4≥0.15% | ||
245 | Nutmeg Oil | IDENTIFICATION | Thin-layer chromatography | myristicine | |
Examine the chromatograms obtained in the test for chromatographic profile | 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. | ||||
TESTS | Relative density | 0.885 to 0.905 | |||
Refractive index | 1.475 to 1.485 | ||||
Optical rotation | +8 to +18 | ||||
Chromatographic profile | "Determine the percentage Content of each of these components. The percentages are within the following ranges: — α-pinene: 15 % to 28 %; — β-pinene: 13 % to 18 %; — sabinene: 14 % to 29 %; — car-3-ene: 0.5 % to 2.0 %; — limonene: 2.0 % to 7.0 %; — γ-terpinene: 2.0 % to 6.0 %; — terpinen-4-ol: 2.0 % to 6.0 %; — safrole: ≤ 2.5 %; — myristicine: 5.0 % to 12.0 %." | ||||
ASSAY | |||||
246 | Oak Bark | IDENTIFICATION | Microscopic examination | powder | |
Physiochemical identification | A red colour develops | ||||
TESTS | Loss on drying | ≤ 10.0 % | |||
Total ash | ≤ 8.0 % | ||||
ASSAY | Content | ≥ 3.0 % of tannins, expressed as pyrogallol (dried drug) | |||
247 | Olive Leaf | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | oleuropein,rutoside trihydrate | ||||
TESTS | Loss on drying | ≤ 10.0 % | |||
Total ash | ≤ 9.0 % | ||||
ASSAY | Content | ≥ 5.0 % of oleuropein (dried drug) | |||
248 | Olive Leaf Dry Extract | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | oleuropein,rutoside trihydrate | ||||
TESTS | Loss on drying | ≤ 8.0 % | |||
ASSAY | Content | ≥ 16.0 % of oleuropein (dried extract) | |||
250 | Opium | IDENTIFICATION | Microscopic examination | powder | |
Thin-layer chromatography | morphine hydrochloride, papaverine hydrochloride,codeine phosphate, noscapine hydrochloride | ||||
TESTS | Thebaine(Liquid chromatography) | thebaine: ≤ 3.0 % (dried drug) | |||
Loss on drying | ≤ 15.0 % | ||||
Total ash | ≤ 6.0 % | ||||
ASSAY | Content | "— morphine : ≥ 10.0 % (dried drug); — codeine: ≥ 2.0 % (dried drug)" | |||
254 | Orange Tincture | IDENTIFICATION | Thin-layer chromatography | naringin, caffeic acid | |
TESTS | Ethanol Content | 63 % to 67 % V/V | |||
Methanol and 2-propanol | ≤ 0.05 % V/V of methanol and ≤ 0.05 % V/V of 2-propanol | ||||
Dry residue | ≥ 6.0 % m/m | ||||
ASSAY |