The solution is nol more intensely coloured than reference solution BS8, Appendix 6.2. Hahdes: 15 ml of a 5% w/v solution in carbon dioxide free water

solution add 0.1 ml of sodium sulphide solution. The solution is nol more intensely coloured than reference solution BS8, Appendix 6.2. Hahdes: 15 ml of a 5% w/v solution in carbon dioxide free water 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 Apomethylalropine: A 0. 1% w/v solution in 0.01M hydrochloric acid exhibits maxima at about 252 nm and 257 nm. The ralio of the absorbance al about 257 nm to that at about 252 nm is not less than 1.17, Appendix 5.5. Relaled substances: Carry out the method for thin-layer chromalography, Appendix 4. 6, using silica gel G as the coaling substance and a mixlure of 60 volumes of ethyl acetate, 15 volumes of anhydrous formic acid, 15 volumes of waler 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 lodobismuthate solution until spots appear. Any secondary spot in the chromatogram obtained with solution (1) is nol more intense lhan the spot in the chromatogram obtained with solution (2). Sulphaled 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 al 105°, Appendix 8.6. Assay: Weigh accurately aboul 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 of0. 1M perchloric acid is equivalent to 0 03664 g of C18H28N2O6. ATROPINE SULPHATEAtropme Sulphate is (1 R,3r,5S)-3-tropoyloxylropainum sulphate monohydrale. Category: Anlicholinergic; antidole to cholineslerase inhibitors. Dose: As anlicholmergic, orally, 250 µg to 2 mg daily in single or divided doses, by; subcutaneous, intramuscular, or by intravenous injection, 400 ug lo 600 ug four to six times a day; as antidote to cholmeslerase inhibitors, by intravenous injection, 2 lo 4 mg initially, followed by mlramuscular injection, 2 mg repeatred every 5 to 10 minutes. Description: Colourless cryslals or white, crystalline powder; odourless .Solubility: Very soluble in waler; freely soluble in ethanol (95%) and in glycerin, praclically insoluble in chloroform and in ether. Storage Store in well-closed, light-resistanl 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 atropme sulphate or wilh the spectrum obtained from atropme sulphate RS. B: To a 2% w/v solution add sodium hydroxide solution, filter and transfer the precipitate with water Dry the precipilate al 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: Between 4.5 and 6.2, determined in a 2.0% w/v solution, Appendix 8.11. Specific optical retation: Between -050° and +0.05°, determined in a 10% w/v solution, using a 2-dm tube, Appendix 8.9 (distinction from hyoscyamme). Apoatropme: Absorbance of a 0.1 % w/v solution 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 for thin-layer chromalography, Appendix 4.6, using silica gel G as the coaling 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)