Appendix 3.50, using beclomethasone dipropionate RS for preparing the standard solution

STANDARDSBeclomelhasone Dipropionate contains not less Than 96.0 per cent and not more than 103.0 per cent of C28H37C10/, calculated with reference To the dried substance. Identification Test A may be omitted if tests B. C and D are carried out Tests B and 0 may be omitted If tests A and C are carried out. A :The infra-red absorption, spectrum, Appendix 5. 4. is concordant win the spectrum obtained from beclomethasone dipropionate RS.If the spectra are not concordant, prepare new spectra using 5% w/v solutions in chloroform IR. B; Complies with The lest for identification of steroid.. Appendix 3. 6. using solvent II and mobile phase D.C:Carry out the oxygen flask method, Appendix 3. 46, on 25 mg and use a mixture of 20 ml of water and 1 ml of I M sodium hydroxide as the absorbing liquid. The liquid gives reaction A of chlorides. Appendix 3. 1. D : Dissolve about 2 mg in 2 rnl of sulphuric acid with shaking; a deep reddish brown colour is produced within 5 minutes. Add the solution to 10 ml of water and mix; the colour is discharged and a clear solution is produced. Light absorption Dissolve 50 mg in sufficient ethanol (95%) to produce 100 ml and dilute 2 ml of this solution to 50 ml with the same solvent. Absorbance of the resulting solution at the maximum at about 238 run, between 0.57 and 0.6O, Appendix 5.5 Specific optical rotation Between +88* and +34° determined in a 1 % w/v solution in dioxan. Appendix 8.9 Related foreign steroids; Complies with the test for related foreign steroids. Method B. Appendix 3. 7, using as solution (3) a solution containing 0. 030% w/v of beclom ethasone 17-propionate RS in a mixture of 90 volumes of chloroform and 10 volumes of methanol.Sulphated ash Not more tharn0.1%. Appendix 3. 22 Loss on drying; Not more than 0.5%, determined on 1 g by drying in an oven at 105° for 3 hours. Appendix 8 6.Assay; Weigh accurately about 2 mg and dissolve in sufficient of dehydrated methanol to produce a solution containing 20 ug of Beclomethasone Dipropionate per ml. To 10 ml of the resulting solution add 10.0 ml of dehydrated methanol (test solution). Carry out The assay of steroids. Appendix 3.50, using beclomethasone dipropionate RS for preparing the standard solution BECLOMBTHASONE DIPROPIONATE INHALERBeclornethasone Inhaler; Beclomethasone Inhalation AerosolBeclomtlhasone Dipropionate Inhaler is a suspension of Beclornethasone Dipropionate in a suitable liquid in a suitable pressurised container .Usual strength; 50 ug m each metered dose. Storage Store in small, non-reactive, light-resistant metal aerosol containers with metered-dose valves and provided with oral inhalation actuators. Store in a cool, dry place Used, empty containers must also be protected from heat and direct sunlight. Labelling ;The label stales (1) the amount of active ingredient in the container, (2) the number of metered doses in the container. (3) the amount of active ingredient delivered per inhalation; (4) that the container should be shaken before use each nrne, (5) a warning that the container is pressurised and must be kept away from heat and direct sunlight and that it must not be punctured, broken or incinerated even when apparently empty. (6) Ihe warning "Keep out of reach of child ren'STANDARDSBeclomethasone Dipropionate Inhaler contains not less than 90.0 per cent and not more than 110.0 per cent of the slated amount of beclomethasone dipropionate, C28H37C107. in the container and delivers not less than 60.0 per cent and not more than 120.0 per cent of the stated amount per inhalation of beclomethasone dipropionate. C28H37C107, by actuation of the valve. Identification: Complies with the test for identification, of steroids. Appendix 3.6, using solvent II and mobile phase D. Apply separately to the plate 10 ul of each of the following solutions. For solution (1) remove Ihe actuator from the pressunsed container, shake the container for about 30 seconds and place it inverted into a small beaker containing 2 ml of a mixture of 9 volumes of chloroform and 1 volume of methanol. Discharge 40 deliveries below the surface of the liquid and use the resulting solution. Solution (2) is a 0.05% w/v solution of beclomethasone dipropionate RS in a mixture of 9 volumes of chloroform and 1 volume of methanol. Content of active ingredient delivered per spray: Complies with the requirement stated under Aerosols using 80 ml of 'dehydrated rnelhanol as solvent. Discharge 40 deliveries. keep the solution on a water-bath for 5 minutes to expel Ihe propetlants and then dilute to 100.0 ml with dehydrated methanol Other requirement;. Complies with Ihe requirements of lesls stated under Aerosols.Assay Remove the pressunsed container from the actuator and remove all labels and markings which may be present onthe container with a suitable solvent. Place the container in a plastic bag/ cool to at least 20° and then carefully pierce a small hole on the shoulder of the container.AllowThe propellants to evaporate (about 3 hours) and remove the top Wash the top and valve of Ihe opened can with dehydrated methanol.Transfer the contents of the container and the washings to a 100-m1 volumetric flask, dilute to volume with dehydrated methanol and mix. Dilute a suitable volume with dehydrated methanol to produce a solution containing 20 ug of Beclomethasone Dipropionate per ml.To 10.0 ml of the resulting solution add 10.0 ml of dehydrated methanol, 2.0 ml of blue tetrazohum solution and mix, add 2.0