w/v and 0.010% w/v respectively of the substance being examined. Solution (4) contains 0.10% w/v each of the substance being examined and prednisone RS. After removal the plate, allow it to dry in air until the odour of solvents is no longer detectable and examine under ultra-violet light (254 nm) Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) The test is not valid unless the chromatogram obtained with solution (4) shows two clearly separated principal spots. Sulphated ash: Not more than 0.1 %, Appendix 3.22 Loss on drying: Not more than 0.5%, determined on 1 g by drying at a pressure not exceeding 0.7 kPa for 3 hours, Appendix 8.6 Assay: Weigh accurately about 0.1 g and dissolve in sufficient aldehyde free ethanol to produce 200.0 ml. Dilute 5.0 ml of this solution with aldehyde free ethanol to 250.0 ml (test solution). Carry out the assay of steroids, Appendix 3.50, using belamethasone RS for preparing the standard solution BETAMETHASONE TABLETSUsual strengths. 0.5 mg; 1.0 mg. Storage: Store in well-closed, light-resistant containers STANDARDSEetamethasone Tablets contain not less than 90.0 per cent and not more Than 110.0 per cent of the stated amount of betamethasone, C22H29FO5. Identification. A : Powder a few tablets and extract with chloroform. Evaporate the extract to dryness. The residue complies with tests A, C and D described under Betamethasone.B'. The residue obtained in test A complies with the test for identification of steroids. Appendix 3.6, using solvent I and mcbile phase A At a fourth point apply to the plate 2ul of a mixture of equal volumes of solution (I) and a 0.25% w/v solution of dexamethasone RS in a mixture of 9 volumes of chloroform and 1 volume of methanol. The chromatogram obtained with this solution shows two closely running spots.Related substances :Transfer a quantity of the powdered tablets equivalent to .about 2 mg of Betamethasone to a glass-stoppered 50-m1 centrifuge tube. Pipette 20 ml of ethanol (95%) into the tube, shake for 2 minutes and allow to stand for 20 minutes with occasional shaking. Centrifuge the mixture for 5 minutes Pipette 10 ml of the clear supernatant liquid into a glass-stoppered tube and evaporate the ethanol on a water-bath with the aid of a current of air to about 0.5 ml, then evaporate wilhout heat to dryness. Pipette 1 ml of a mixture of 9 volumes of chloroform and 1 volume of methanol, insert the stopper and mix.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment