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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
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