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NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
338 | Spike Lavender Oil | IDENTIFICATION | Thin-layer chromatography | cineole , linalol and linalyl acetate | |
TESTS | Relative density | 0.894 to 0.907. | |||
Refractive index | 1.461 to 1.468. | ||||
Optical rotation | -7° to + 2°. | ||||
Acid value | ≤ 1.5, determined on 5.00 g of the essential oil to be examined. | ||||
Chromatographic profile | spike lavender oil reference solution; limonene | ||||
ASSAY | |||||
342 | St. John's Wort | IDENTIFICATION | Microscopic examination | powder | |
High-performance thin-layer chromatography | hyperoside and rutoside trihydrate, chlorogenic acid | ||||
TESTS | Loss on drying | ≤10.0% | |||
Total ash | ≤7.0% | ||||
Foreign matter | ≤3% of stems with a diameter greater than 5 mm and maximum 2 per cent of other foreign matter. | ||||
ASSAY | Content | ≥ 0.08 % of total hypericins, expressed as hypericin (C30H16O8 ; Mr 504.4) (dried drug). | |||
343 | Standardised Aloes Dry Extract | IDENTIFICATION | Thin-layer chromatography | aloe emodin and of barbaloin | |
TESTS | Loss on drying | ≤4.0% | |||
Total ash | ≤2.0% | ||||
ASSAY | Content | 19.0 to 21.0 % of hydroxyanthracene derivatives, expressed as barbaloin (C21H22O9 ; Mr 418.4), adjusted if necessary (dried extract). | |||
344 | Standardised Belladonna Leaf Dry Extract | IDENTIFICATION | Thin-layer chromatography | chlorogenic acid and rutoside trihydrate | |
TESTS | Loss on drying | ≤5.0 % | |||
Atropine/Thin-layer chromatography | hyoscyamine sulfate | ||||
ASSAY | Content | 0.95 to 1.05 % of total alkaloids, expressed as hyoscyamine (C17H23NO3 ; Mr 289.4) (dried extract). | |||
346 | Standardised Capsicum Soft Extract | IDENTIFICATION | Thin-layer chromatography | f capsaicin and dihydrocapsaicin | |
TESTS | Dry residue | ≥ 70.0 per cent m/m, determined on 2.00 g. | |||
ASSAY | Content | 2.0 to 2.4 % of total capsaicinoids, expressed as capsaicin (C18H27NO3 ; Mr 305.4) | |||
347 | Standardised Capsicum Tincture | IDENTIFICATION | Thin-layer chromatography | capsaicin and dihydrocapsaicin | |
TESTS | Ethanol | 95 to 105 % of the content stated on the label | |||
Methanol and 2-propanol | ≤0.05 % V/V of methanol and ≤0.05 % V/V of 2-propanol. | ||||
Liquid chromatography | capsaicin and nonivamide | ||||
ASSAY | Content | 90 to 110 % of the nominal content of total capsaicinoids, expressed as capsaicin (C18H27NO3 ; Mr 305.4), | |||
348 | Standardised Cascara Dry Extract | IDENTIFICATION | Thin-layer chromatography | barbaloin and emodin | |
TESTS | Loss on drying | ≤5.0% | |||
ASSAY | Content | — hydroxyanthracene glycosides expressed as cascaroside A (C27H32O14; Mr 580.5): 8.0 per cent to 25.0 per cent m/m (dried extract) and 90 per cent to 110 per cent of the nominal content stated on the label; — cascarosides expressed as cascaroside A (C27H32O14; Mr 580.5): minimum 60 per cent of the hydroxyanthracene glycosides. | |||
349 | Standardised Cinchona Liquid Extract | IDENTIFICATION | Thin-layer chromatography | quinidine, cinchonidine , cinchonine and quinine | |
TESTS | Ethanol | 95 to 105 %of the content stated on the label. | |||
Methanol and 2-propanol | ≤0.05 % V/V of methanol and ≤ 0.05 % V/V of 2-propanol. | ||||
Dry residue | Minimum 12.0 per cent for glycerol-free standardised cinchona liquid extract and minimum 30.0 per cent for glycerol-containing standardised cinchona extract, determined on 2.0 g. | ||||
ASSAY | Content | Minimum 4.0 per cent and maximum 5.0 per cent of total alkaloids, of which 30 per cent to 60 per cent are alkaloids of the quinine type (C20H24N2O2 ; Mr 324.4) | |||
350 | Standardised Frangula Bark Dry Extract | IDENTIFICATION | Thin-layer chromatography | barbaloin | |
TESTS | Loss on drying | ≤5.0% | |||
ASSAY | Content | 15.0 to 30.0 % of glucofrangulins, expressed as glucofrangulin A (C27H30O14; Mr 578.5) (dried extract). | |||
351 | Standardised Horse-chestnut Dry Extract | IDENTIFICATION | Thin-layer chromatography | aescin and sucrose | |
TESTS | Loss on drying | ≤6.0% | |||
ASSAY | Content | 6.5 to 10.0 % of total triterpene glycosides, expressed as protoaescigenin (C30H50O6 ; Mr 506.7) (dried extract). | |||
352 | Standardised Ipecacuanha Liquid Extract | IDENTIFICATION | Thin-layer chromatography | emetine hydrochloride | |
TESTS | Ethanol | 95 to 105 % of the quantity stated on the label. | |||
ASSAY | Content | 1.80 to 2.20% of total alkaloids, expressed as emetine (C29H40N2O4 ; Mr 480.6). | |||
353 | Standardised Ipecacuanha Tincture | IDENTIFICATION | Thin-layer chromatography | concentrated ammonia | |
TESTS | Ethanol | 95 to 105 % of the quantity stated on the label. | |||
ASSAY | Content | 0.18to 0.22 % m/m of total alkaloids, expressed as emetine (C29H40N2O4 ; Mr 480.6). | |||
354 | Standardised Opium Dry Extract | IDENTIFICATION | Thin-layer chromatography | morphine hydrochloride;papaverine hydrochloride;codeine phosphate;f noscapine hydrochloride | |
TESTS | Loss on drying | ≤5.0% | |||
Liquid chromatography | Thebaine | ||||
ASSAY | Content | — morphine (C17H19NO3 ; Mr 285.3): 19to 21%; — codeine (C18H21NO3 ; Mr 299.4): ≥ 2 %. | |||
355 | Standardised Opium Tincture | IDENTIFICATION | Thin-layer chromatography | morphine hydrochloride;papaverine hydrochloride;codeine phosphate;f noscapine hydrochloride | |
TESTS | Ethanol | 31 to 34 % V/V. | |||
Dry residue | ≥4.0 % m/m, determined on 3.00 g. | ||||
ASSAY | Content | — morphine (C17H19NO3 ; Mr 285.3): 0.95 to 1.0%; — codeine (C18H21NO3 ; Mr 299.4): ≥ 0.1 %. |