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Friday, July 10, 2009

Category Antibacterial. Dose: 500 mg to 2 g daily, in divided doses. Description: White to off-white

acid, slightly soluble in light petroleum Storage: Store in well-filled, well-closed, light-resistant containers at a temperature not exceeding 15° Labelling: The label states (1) the name and quantity of any added antioxidant: (2) whether the contents are suitable for use in the manufacture of injectable preparations STANDARDS Light absorption: Absorbance of a 1. 0% w/v solution in ethanol (95%) at the maximum at about 269 nm, not more than 1. 0, Appendix 5. 5. Weight per ml: Between 0. 945 g and 0. 965 g. Appendix 8. 15. Optical rotation: Between +3. 5° and +6. 0°, Appendix 8. 9. Refractive index: Between 1. 4758 and 1. 4798, Appendix 8: 13. Foreign fatty substances: A: A mixture of 2 ml of the oil and 8 ml of ethanol (95%) is clea.. Appendix 6. 1. B; Shake 10. 0 ml with 20. 0 ml of light petroleum (boiling range 60° to 80°) and allow to separate; the volume of the lower layer is not less than 16.0 ml. Acetyl valu: Not less than 143, Appendix 3.26. Acid value: Not more than 2.0, Appendix 3.27. Hydroxyl value Not less than 150, Appendix 3.29. Iodine value: Between 82 and 90, Appendix 3.30. Peroxide value: Not more than 5.0, Appendix3.31. Saponiflcation value: Between 176 and 187, Appendix 3. 32. HYDROGENATED CASTOR OILCastor Wax, Opalwax Hydrogenated Castor Oil is refined, bleached, hydrogenated and deodorised castor oil. It consists mainly of the triglyceride of hydroxystearic acid Category: Pharmaceutical aid (stiffening agent, coating material). Description: White to yellow powder of uniform consistency and texture. It may have a hard, waxy consistency. Solubility Soluble in acetone, in chloroform and in carbon tetrachloride; insoluble in water. Storage; Store in well-closed containers in a cool place Avoid exposure to excessive heat. STANDARDS Melting range Between 85° and 88°, determined by Method II, Appendix 8. 8 Free fatty acids: Weigh accurately about 20 g, melt on a water-bath, add 75 ml of hot ethanol (95%), previously neutralised to phenolphthalein solution with 0. 1M sodium hydroxide, swirl, add 1 ml of phenolphthalein solution and titrate with 0. 1M sodium hydroxide, swirling vigorously until the solution remains faintly pink after being shaken for 60 seconds; not more than 11. 0 ml of 0. 1M sodium hydroxide is required. Heavy metals: Not more than 10 ppm, determined on 2. 0 g by Method B, Appendix 3. 12. Acetyl value: Not less than 143, Appendix 3.26. Acid value: Not more than 2. 0, Appendix 3.27. Hydroxyl value Between 154 and 162, Appendix 3.29. Iodine value: Not more than 5. 0, Appendix 3. 30. Peroxide value Not more than 5.0, Appendix 3. 31. Saponification value: Between 176 and 182, Appendix 3.32.CEFADROXIL C16F17N3O5S.H2O Mot. Wt. 381. 40 Cefadroxil is 7-[(R)-2-amino-2-(4-hydroxyphenyl) acetamidoJ - 3 - methy I- 3 - cephem_4-carboxylic acid monohydrate. Category Antibacterial. Dose: 500 mg to 2 g daily, in divided doses. Description: White to off-white, crystalline. powder. Solubility: Slightly soluble in water, practically insoluble in ethanol (95%), in chloroform and in ether. Storage: Store in tightly-closed containers in a cool place. STANDARDSCefadroxil contains not less than 95. 0 per cent and not more than 101. 0 percent of C16H17N3O5S, calculated with reference to the anhydrous substance. Identification: A: The infra-red absorption spectrum. Appendix 5.4, is concordant with the reference spectrum of cefadroxil or with the spectrum obtained from cefadroxil RS. B:

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