application is blue Melting range Between 78° and 88*, determined by Method Appendx 8.8-Heavy metals Not more than 40 ppm, determined on 0.5 g by Method B, Appendix 3.12 Acid value. Not more than 12.0, determined by the following method Weigh accurately about 2 g (w) in a flask fitted with a reflux condenser, add 40 ml olxylene and heal until the substance has dissolved Add 20 ml of ethanol (95%) and titrate the hot solution with 0.5M ethanolic potassium hydroide. using phenolphthalain solution as Indicator, until a pink colour persists lor at least 10 seconds (n, ml) Repeat be operation without the substance being examined (n2 ml) Calculate the acid value from the expression 28.05(n1n2)/w. Saponification value. Between 78 and 95, determined by the following method To the titrated solution from the determination of the Acid value, add 20.0 ml of 0.5M ethanolic potassium hydroxide and boil under a reflux concderiser for 3 hours Titraie the hat solution immediately with 0.5 M hydrochloric acid, using 1 ml of phenolphthalein solution as indicator, until the red colour is decharged Reheat the solution to boiling and continue the titration. if necessary, until the red colour no longer reappears on heating (n3 ml) Repeat the operation without the substance being examined (n4 ml) Calculate the saponificaton value frorn the expression a+[28 05(n4-n3)w] where a is the acid value Sutphated asn Not more than 0.26%. determined on 2 g, Appendix 3.22.CASTOR OILCastor Oil is the fixed oil obtained by cold expression from the seeds of Ricinus communis Linn (Fam Euphorbiaceae) it may contain suitable antioxidants Category Laxative; pharmaceutical aid (plastictser) Dose 6to 15 ml. Description: Pale yellowish or almost colourless, transparent, viscid liquid; odour slight and characteristic Solubility Mtscible with chloroform, with ethanol (96%), with ether and with gtacial acetic acid, slightly soluble in tight petroleum Storage Store In well-tilled, well-closed, light-resistant containers at a temperature not exceeding 15* Labelling The label states (1)the name and quantity of any added antioxldant, (2) whetner the contents are suitable for use in the manufacture of injectable preparations. STANDARD Slight 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 +60°, Appendx 89. 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 clear, Appendix 6.1.B Shake 10.0 ml with 20.0 ml of light palroleum (boiling range 60* to 80") and allow to separate, the volume of the lower layer Is not less than 16.0 ml Acetyl value Not less than 143. Appendix 3.26. acid value Not more than 2.0, Appendix 327 Hydroxyl value: Not less than 150, Appendix 3.29 lodine value Between 82 and 90, Appendix 3.30 Peroxide value Not more than 5.0, Appendix 331. Saponiflcation value. Between 176 and 187. Appendix 3.32 HYDROGENATED CASTOR OILCastor Wax, OpalwaxHycdrogenated 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
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