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NO. Products Name Types Items BP quality control specification Chp quality control specification
298 Raspberry Leaf IDENTIFICATION Microscopic examination powder
Thin-layer chromatography chlorogenic acid,fhyperoside and rutoside trihydrate
TESTS Loss on drying ≤10.0%
Total ash ≤8.0%
ASSAY Content ≥ 3.0 % of tannins, expressed as pyrogallol (C6H6O3; Mr 126.1) (dried drug)
299 Red Peony Root IDENTIFICATION Microscopic examination powder powder
Thin-layer chromatography paeoniflorin and paeonol paeoniflorin
TESTS Loss on drying ≤12.0%
Total ash ≤8.0%
Ash insoluble in hydrochloric acid ≤1.0%
ASSAY Content ≥1.8% of paeoniflorin (C23H28O11; Mr 480.5) (dried drug) paeoniflorin (C23H28O11; Mr 480.5),≥1.8%
300 Red Poppy Petals Microscopic examination powder
Thin-layer chromatography quinaldine red and sulfan blue
TESTS Loss on drying ≤12.0%
Total ash ≤11.0%
Foreign matter ≤2%
ASSAY
301 Refined and Quantified Ginkgo Dry Extract IDENTIFICATION Thin-layer chromatography chlorogenic acid and of rutoside trihydrate
TESTS Liquid chromatography Flavonoids、Terpene lactones、Ginkgolic acids、
ASSAY Content — flavonoids, expressed as flavone glycosides (Mr 756.7): 22.0 %to 27.0 %(dried extract); — bilobalide: 2.6 %to 3.2 %(dried extract); — ginkgolides A, B and C: 2.8 %to 3.4 %(dried extract); — ginkgolic acids: ≤ 5 ppm (dried extract).
302 Refined and Standardised Capsicum Oleoresin IDENTIFICATION Thin-layer chromatography capsaicin and dihydrocapsaicin
TESTS Liquid chromatography Nonivamide
Water ≤8.0%
ASSAY Content 12.0 to 18.0 % m/m of total capsaicinoids, expressed as capsaicin (C18H27NO3 ; Mr 305.4).
303 Refined and Standardised Fresh Bilberry Fruit Dry Extract IDENTIFICATION Thin-layer chromatography bilberry dry extract
TESTS Liquid chromatography Total anthocyanidins
Total ash ≤2.0%
Loss on drying ≤4,5%
ASSAY Content 32.4 to 39.6 % of anthocyanins, expressed as cyanidin 3-O-glucoside chloride [chrysanthemin (C21H21ClO11; Mr 484.8)] (dried extract)
304 Refined and Standardised Milk Thistle Dry Extract IDENTIFICATION Thin-layer chromatography silibinin and taxifolin
TESTS Water ≤4.0%
ASSAY Content 90 to 110 %of the nominal content of silymarin, expressed as silibinin (C25H22O10; Mr 482.4), stated on the label. The nominal content of silymarin is within the range 30 %m/m to 65 %m/m (anhydrous extract). The content of silymarin corresponds to: — sum of the contents of silicristin and silidianin (both C25H22O10; Mr 482.4): 20 to 45 %, calculated with reference to total silymarin; — sum of the contents of silibinin A and silibinin B (both C25H22O10; Mr 482.4): 40 to 65 %, calculated with reference to total silymarin; — sum of the contents of isosilibinin A and isosilibinin B (both C25H22O10; Mr 482.4): 10 to 20 %, calculated with reference to total silymarin.
305 Restharrow Root IDENTIFICATION Microscopic examination powder
Thin-layer chromatography resorcinoland vanillin
TESTS Loss on drying ≤10.0%
Total ash ≤8.0%
ASSAY Extractable matter ≥ 15.0%
306 Rhatany Root IDENTIFICATION Microscopic examination powder
Thin-layer chromatography f thymol and dichlorophenolindophenol, sodium salt
TESTS Loss on drying ≤12%
Total ash ≤5.5%
Foreign matter ≤ 2 % of foreign matter and≤ 5% of fragments of crown or root exceeding 25 mm in diameter. Root without bark may be present in very small quantities.
ASSAY
307 Rhatany Tincture IDENTIFICATION Thin-layer chromatography thymol and dichlorophenolindophenol, sodium salt
TESTS Ethanol 63 to 67 %V/V.
Methanol and 2-propanol ≤0.05% V/V of methanol and maximum 0.05 % V/V of 2-propanol.
ASSAY Content ≥1.0% m/m of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1)
308 Rhubarb IDENTIFICATION Microscopic examination powder
Thin-layer chromatography emodin
TESTS Loss on drying ≤12.0% ≤15.0%
Total ash ≤12.0% ≤10.0%
Ash insoluble in hydrochloric acid ≤2.0%
ASSAY Content The total anthraquinone contains aloe emodin, rhein, emodin and chrysophanol and the total amount of emodin methyl ether, ≥ 1.5%.Contains free anthraquinones aloe emodin, rhein, emodin, chrysophanol and the total amount of emodin methyl ether,≥ 0.2%.
309 Roselle IDENTIFICATION Microscopic examination powder
Thin-layer chromatography quinaldine red and sulfan blue
TESTS Loss on drying ≤11.0%
Total ash ≤10.0%
Foreign matter ≤ 2 % of fragments of fruits (red funicles and parts of the 5-caverned capsule with yellowish-grey pericarp, whose thin walls consist of several layers of differently directed fibres; flattened, reniform seeds with a dotted surface) and ≤ 2 % of other foreign matter.
ASSAY Content ≥13.5 %of acids, expressed as citric acid (C6H8O7; Mr 192.1) (dried drug).
310 Rosemary Leaf IDENTIFICATION Microscopic examination powder
Thin-layer chromatography borneol , bornyl acetate;caffeic acid and rosmarinic
TESTS Foreign matter ≤5 % of stems and ≤ 2 % of other foreign matter.
Total ash ≤9.0%
Water ≤100 mL/kg
ASSAY Content — ≥ 12 mL/kg of essential oil (anhydrous drug); — ≥ 3 per cent of total hydroxycinnamic derivatives, expressed as rosmarinic acid (C18H16O8 ; Mr 360.3) (anhydrous drug).
311 Rosemary Oil IDENTIFICATION Thin-layer chromatography borneol , bornyl acetate , cineole
TESTS Relative density 0.895 to 0.920
Refractive index 1.464 to 1.473
Optical rotation -5° to + 8°
Acid value ≤ 1.0
ASSAY
312 Round Amomum Fruit IDENTIFICATION Microscopic examination powder
Thin-layer chromatography bornyl acetate , cineole
TESTS Water ≤ 120 mL/kg
Total ash ≤8.0%
ASSAY Content — essential oil: ≥ 50 mL/kg for A. krervanh (anhydrous drug) and ≥ 40 mL/kg for A. compactum (anhydrous drug); — 1,8-cineole (C10H18O; Mr 154.3): ≥ 65.0 per cent of the essential oil.
313 Safflower Flower IDENTIFICATION Microscopic examination powder
Thin-layer chromatography rutoside trihydrate and quercetin dihydrate
TESTS Loss on drying ≤11.0% ≤13.0%
Total ash ≤10.0% ≤15.0%
Ash insoluble in hydrochloric acid ≤3.0% ≤5.0%
Foreign matter ≤2.0%
ASSAY Content ≥ 1.0 % of total flavonoids, expressed as hyperoside (C21H20O12; Mr 464.4) (dried drug). Hydroxyl safflower yellow pigment (C27H32O16) ≥ 10%. The content of kaempferol shall ≥ 0.050%
Water-soluble extractive ≥ 30.0%
314 Sage Leaf IDENTIFICATION Microscopic examination powder
Thin-layer chromatography thujone and cineole
TESTS Foreign matter ≤ 3 % of stems and ≤ 2% of other foreign matter.
Total ash ≤6.0%
Water ≤100 mL/kg, determined on 20.0 g
ASSAY Content Essential oil content: — for the whole drug, minimum 12 mL/kg (anhydrous drug); — for the cut drug, minimum 10 mL/kg (anhydrous drug).
315 Sage Tincture IDENTIFICATION Thin-layer chromatography thujone and of cineole
TESTS Ethanol content 64 to 69 % V/V
Methanol and 2-propanol ≤0.05 % V/V of methanol and ≤ 0.05 % of 2-propanol.
Dry residue ≥ 2.0 % m/m, determined on 3.00 g.
ASSAY Content ≥ 0.1 % m/m of essential oil.
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