solution add 0.1 ml of sodium sulphide solution. The solution is not more intensely coloured than reference solution BS8, Appendix 6.2. Hahdes: 15 ml of a 5% w/v solulion in carbon dioxide free waler complies with the limit test for chlorides, Appendix 3.10, using 0.3 ml of chloride standard solution [25 ppm Cl) for preparing the standard. Apomethytatropine A 0 1% w/v sotution in 0 01M hydrochloric acid exhibils maxima at about 252 nm and 257 nm The ralio of the absorbance at about 257 nm to that at about 252 nm is not less than 1 17, Appendix 5.5 Related substances: Carry out the method for thin-layer chromatography, Appendix 4.6, using silica gel G as the coating substance and a mixture of 60 volumes of ethyl acetate, 15 volumes of anhydrous formic acid, 15 volumes of water and 10 volumes of methanol as the mobile phase. Apply separately to the plate 5 µl of each of two solutions in methanol (90°10) containing (1) 4.0% w/v of the substance being examined and (2) 0.020% w/v of the substance being examined. After removal of the plate, dry it at 105° until the odour of the solvent is not deteclable. Allow it to cool to room temperature and spray with dilute potassium iodobismuthate solution until spots appear. Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2). Sulphated ash: Not more than 0.1 %, Appendix 3.22. Loss on drying: Not more than 0.5%, determined on 1 g by drying in an oven at 105°, Appendix 8.6. Assay: Weigh accurately about 0.3 g and dissolve in 50 ml of anhydrous glacial acetic acid Carry out Method A for non-aqueous titration, Appendix 3.45, determining the end-point potentiometncally. Perform a blank determination and make any necessary correction. Each ml of 0.1M perchloric acid is equivalent to 0.03664 g of C18H28N2O6. ATROPINE SULPHATEAtropine Sulphale is (1 R,3r,5S)-3-tropoyloxytropainum sulphate monohydrale. Category: Anticholinergic; antidote to cholinesterase inhibitors. Dose: As anticholmergic, orally, 250 ug to 2 mg daily in single or divided doses; by subcutaneous, intramuscular, or by intravenous injection, 400 ug to 600 ug four to six times a day; as antidote to cholmesterase inhibitors, by intravenous injection, 2 to 4 mg initially, followed by intramuscular injection, 2 mg repeated every 5 to 10 minutes. Description: Colourless crystals or white, crystalline powder, odourless. Solubility: Very soluble in water, freely soluble in ethanol (95%) and in glycerin; practically insoluble in chloroform and in ether.Slorage: Store in well-closed, light-resistant containers.STANDARDSAlropine Sulphate contains not less than 99.0 percent and not more than 101.0 per cent of (C17H23NO3)2,H2SO4 calculated with reference to the anhydrous substance. Identification Test A may be omitted if tests B, C and D are carried out. Tests B and C may be omitted if tests A and D are carried out. A: The infra-red absorption spectrum, Appendix 5.4, is concordant with the reference spectrum of alropine sulphate or with the spectrum obtained from atropine sulphate RS. B: To a 2% w/v solution add sodium hydroxide solution, filter and transfer the precipitate with water. Dry the precipitate at 60°. To 5 mg of the residue add 5 drops of fuming nitric acid and evaporate to dryness on a water-bath Cool the family yellow coloured residue and add 2 ml of acetone and 4 drops of a 3% w/v solution of potassium hydroxide in methanol; a violet colour is produced. C: Gives the reaction of alkaloids, Appendix 3.1.D: A 5% w/v solution gives the reactions of sulphates, Appendix 3. 1. pH: Bel we en 4.5 and 6.2, determined in a 2.0% w/v solution, Appendix 8.11. Specific optical relation: Belween -0.50° and +0.05°, determined in a 10% w/v solution, using a 2-dm tube, Appendix 8.9 (distinction from hyoscyamine) Apoatropine: Absorbance of a 0.1 % w/v solulion in 0.01M hydrochloric acid at about 245 nm, not more than 0.4, Appendix 5.5 (about U.5%). Foreign alkaloids and decomposition products Carry out the method thin-layer chromatography, Appendix 4.6, using silica gel G as the coating substance and a mixture of 90 volumes of acetone, 7 volumes of water and 3 volumes of strong ammonia solution as the mobile phase. Apply separately to the plate 10 µl of each of three solutions of the substance being examined in methanol containing (1) 2.0% w/v, (2)
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