cholecalciferol or ergocalclferol, in mg, from the difference between the absorbances at about

H44O in cholecalciferol RS or of C?SH440 in ergocalciferol RS, as appropriate. CALCIFEROL INJEC HONCalciferol Injection is a sterile solution of Cholecalciferol or Ergocalclferol in Ethyl Oleate. Usual strength: 7.5 mg of Cholecalciferol or Ergocalclferol per ml. [Cholecalciferol or Ergocalclferol contains 40,000 Units of antirachitic activity (vitamin D) in each mg]. Description: Pale yellow, oily liquid. Storage: Store in single dose, light-resistant containers in a cool place Labelling: The label states (1) that the preparation is for intramuscular use only; (2) the number of Units of antirachitic activity (vitamin D) per ml. STANDARDSCalciferol Injection contains not less than 90.0 per cent and not more than 110.0 per cent of the stated amount of cholecalciferol, C27H44O or ergocalclferol, C?gH440 Identification: To 1 ml of a 0.2% v/v solution of the injection in ethanol-free chloroform add 9 ml of antimony trichloride solution. The light absorption of the resulting solution exhibits a maximum at about 500 nm, Appendix 5.5. Other requirements: Complies with the requirements of tests stated under Injectable Prepations (Injections). Assay: Carry out the following procedure in subdued light. Weigh accurately about 0.1 g of the injection and dilute to 50.0 ml with dry 1,2-dichloroethane that has been purified by passing it through a column of silica gel. To 1.0 ml of this solution add rapidly 9 ml of antimony trichloride in 1,2-dichlomethane solution and measure the absorbance of the resulting solution at about 500 run and about 550 run, Appendix 5.5, 90 to 120 seconds after adding the reagent. Repeat the operation using 1.0 ml of a 0.002% w/v solution of cholecalciferol RS or ergocalclferol RS in dry, purified 1,2-dichloroethane beginning at the words "add rapidly 9 ml of....... ". Calculate the content of cholecalciferol or ergocalclferol, in mg, from the difference between the absorbances at about 500 nm and 550 rim and from the declared content of C28H44O in cholecalciferol RS or of C28H44O in ergocalclferol RS, as appropriate. Calculate the percentage w/v of cholecalciferol or ergocalclferol taking 0.87 g as the value of the weight per ml of the injection: CALCIFEROL ORAL SOLUTION Calciferol Oral Drops; Calciferol Solution Calciferol Oral Solution is a solution of Cholecalciferol or Ergocalclferol in a suitable vegetable oil and may be prepared by warming to 40° a 1 % w/v suspension of Cholecalciferol or Ergocalclferol in a suitable vegetable oil, such as Arachis Oil, carbon dioxide being bubbled through it to facilitate solution, and adding a sufficient quantity of the oil to produce a solution containing the stated amount of Cholecalciferol or Ergocalclferol. Usual strength: 75 µg of Cholecalciferol or Ergocalclferol per ml. [Cholecalciferol or Ergocalclferol contains 40,000 Units of antirachitic activity (vitamin D) in each mg]. Description: Pale yellow, oily liquid, odour, slight but not rancid. Storage: Store in well-filled, well-closed, light-resistant containers in a cool place Labelling: The label states the number of Units of antirachitic activity (vitamin D) per ml. STANDARDSCalciferol Oral Solution contains not less than 85.0 per cent and not more than 120.0 per cent of the stated amount of cholecalciferol, C27H44O. or ergocalclferol, C28H44O. Identification: To 1 ml of a 20% v/v solution in ethanol free chloroform add 9 ml of antimony trichloride solution. The light absorption of the resulting solution exhibits a maximum at about 500 run, Appendix 5.5. Other requirements: Complies with the requirements,of tests stated under Oral Liquids. Assay: Carry out the following procedure in subdued light. Weigh accurately about 1.5 g, add 0.1 g of hydroqumone and 25 ml of 0.5M ethanohc potassium hydroxide, boil under a reflux condenser for 20 minutes, cool and add 50 ml of water. Extract with three quantities, each of 30 ml, of ether, wash the combined ether. extracts with 20 ml of water, then with 20 ml of 0.5M potassium hydroxide and finally with successive quantities, each of 20 ml, of water until the washings are no longer alkaline to phenolphthalem solution Filter the ether solution through absorbent cotton, wash with two quantities, each of 10 ml, of ether and evaporate the combined extracts and washings to dryness under oxygen free nitrogen by immersion in a water-bath at 50° Dissolve the residue in about 10 ml of hexane, transfer to a column (20 cm x 10 mm) packed with deactivated alumina and elute continuously with a 15 to 20% v/v solution of ether in hexane, using a flow rate of 1 to 2 ml per minute and collecting the fraction that contains the calciferol (identified conveniently by testing ahquots of successive 10-m1 fractions with antimony trichloride solution). Evaporate the solvent under oxygen free nitrogen at a temperature not exceeding 50° and dissolve the residue in 5 0 ml of ethanol free chloroform. Using duplicate 1.0-m1 portions of this solution add rapidly 9 ml of antimony trichloride solution and measure the absorbance of each solution at about 500 nm and 550 nm, 90 to 120 seconds after adding the reagent, Appendix 5.5. Repeat the operation using duplicate 1.0-m1 portions of a solution containing a known amount of cholecalciferol RS or ergocalclferol RS in ethanol free chloroform and beginning at the words "add rapidly 9 ml of antimony trichloride solution..... ". Calculate the content of cholecalciferol or ergocalclferol, in mg, from the difference between the absorbances at about 500 nm and 550 nm and from the declared content of C27H44O in cholecalciferol RS or of