method for thin-layer chromatography, Appendix 4. 6, using silica gel GF254 as the coating substance and a mixture of 60 volumes of chloroform

Carry out the method for thin-layer chromatography, Appendix 4. 6, using silica gel GF254 as the coating substance and a mixture of 60 volumes of chloroform, 10 volumes of ether and 10 volumes of glacial acetic acid as the mobile phase Apply separately to the plate 10 µl of each of the following solutions For solution (1) dissolve 0.2 g of the substance being examined in sufficient glacial acetic acid to produce 10 ml. For solution (2) dilute 1 ml of solution (1) to', 4 ml with glacial acetic acid For solution (3) dilute 1 ml of solution (1) to 200 ml with glacial acetic acid. For solution (4) dissolve 25 mg of albendazole RS in sufficient glacial acetic acid to produce 5 ml. After removal of the plate, allow it to dry in air and examine under ultra-violet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the principal spot. in the chromatogram obtained with solution (3) Heavy metals: Not more than 10 ppm, determined on 2.0 g by Method B, Appendix 3.12. .Sulphated ash: Not more than 0 2%, Appendix 3. 22. Loss on drying: Not more than 0.5%, determined on 1 g by drying in an oven at 105o for 4 hours, Appendix 8. 6. Assay. Weigh accurately about 0.5 g, dissolve in 80 ml of anhydrous glacial acetic acid and carry out Method B for non-aqueous titration, Appendix 3.45, using crystal violet solution as indicator. Perform a blank determination and make any necessary correction. Each ml of 0.1 M perchloric acid is equivalent to 0 02653 g of C12H15N3O2 SALBENDAZOLE swallowing. STANDARDSAIbendazole Tablets contain not less than 92.5 per cent and not more than 107 5 per cent of the stated amount of albendazole, C12H15N3O2Sldentification A Carry out the method for thin-layer chromatography, Appendix 4. 6, using silica gel GF254 as the coating substance and a mixture of 60 volumes of chloroform, 10 volumes of ether and 10 volumes of glacial acetic acid as the mobile phase apply separately to the plate 1 0 p.I of each of the following solutions. Prepare solution (1) in the following manner Add a quantity of the powdered tablets equivalent to 200 mg of Albendazole to 20 ml of a mixture of 1 S volumes of chloroform and 1 volume of formic acid, warm the suspension on a water-bath for 15 minutes, cool and filter. Dilute 10 ml of the filtrate with an equal volume of glacial acetic acid For solution (2) dissolve 25 mg of albendazole RS in sufficient glacial acetic acid to produce S ml. After removal of the plate, allow it tc -try in air and examine under ultra-violet light (254 nm). The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). B: Extract a quantity of the powdered tablets equivalent to 100 mg of Albendazole with 100 nil of 0.1 M methanohc hydrochloric acid, filter and dilute 1 ml of the filtrate to 100 ml with 0.1M sodium hydroxide. Absorbance of the resulting solution at the maximum at about 309 rim, about 0.74, Appendix 5.5. Other requirements: Comply with the requirements of tests stated under Tablets Assay: Weigh and powder 20 tablets Weigh accurately,a quantity of the powder equivalent to about 0 1 g of Albendazole, add about 150 nil 0.1 M methanohc hydrochloric acid, shake for 15 minutes and dilute to 250 0 ml with O. IM methanohc hydrochloric acid. Mix, filter and dilute 5.0 ml of the filtrate to 250.0 ml with O 1 M sodium hydroxide. Measure the absorbance of the resulting solution at the maximum at about 309 nm, Appendix 5.5. Calculate the content of C12H15N3O2S taking 742 as the value of A(1%, 1 cm) at the maximum at about 309 nm HUMAN ALBUMINHuman Normal Albumin; Human Albumin Solution Human Albumin is a sterile non-pyrogenic solution of the albumin component obtained from pooled human blood or from normal placentae frozen immediately after collection. It is obtained by fractionating source material such as blood, plasma, serum or placentae from healthy human donors and tested individually for the absence of hepatitis B surface antigen and HIV antibodies and complies with other tests and requirements prescribed by the appropriate national control authority Source material obtained from donors who do not meet all the requirements stated may be used provided that it has been demonstrated to the national control authority that the process of fractionation will remove any known agent capable of adversely affecting the health of subjects treated with the preparation. It may be prepared from pooled source materials by precipitation with organic solvents under controlled conditions of pH, ionic strength and temperature or by chromatography or by any other method which does not affect the integrity of the product and has been shown to yield consistently a product containing not less than 95% w/v of thetotal protein as albumin which is safe for intravenous injection. Residual organic solvent, if present, is removed by freeze-drying or other suitable treatment