OTOBRIGHT EAR DROPS SUNVET HEALTH CARE | IGHT EAR DROPS. ‘PO: SHAMBHUWALANAHAN, DISTRICT: SIRMOUR (HP. _ Ofloxacin, Beclomethasone Dipropionate,Clvimazole& Lignocane Hel Analytical method of Beclomethasone Dipropionate USP Beclomethasone Dipropi Beclomethasone Diproplonate: CyHyCI0, ---621.04 Pregna-t,4-diene-3,20-dione, S-chloro-11-hydroxy-16-methyl17.21-bia(1-oxopropoxy, (11®, 18% ‘9-Chioro-11F ,17,21-trinydroxy-16? -methylpregna- 4-diene-3,20-dione 17,21-dipropionate --.[5534- 09-8) Monohydrate $39.07. » Beclomethasone Dipropionate is anhydrous or contains one molecule of water of hydration. It contains not less than 97.0 percent and not more than 103.0 percent of C.H=:CIO,, calculated on the dried basis Packaging and storage— Preserve in wellclosed containers, USP Roforence standards‘ 11)— USP Beclomethasone Diprapionate RS USP Testosterone Propionate RS, Identitication, infared Absomption ‘1 Specific rotation ‘ 7815' : between +86" and +94: Test solution: 10 mg per rol, in dioxane. Loss on drying ' 731’ — Dry it at 105" for 3 hours: the anhydrous form loses not more than 0.5% of its weight; the monohydrate form loses between 2.8% and 3.8% of ts weight. esidue on is £ 281} : not more than 0.1%. Assay— “Mobile phaso— Prepare a suitable degassed solution of 3 volumes of acetonitrile in 2 volumes of ‘ater, such thatthe retention time of beclomethasone dipropionate is approximately 6 minutes and that of testosterone propionate is approximately 10 minutes. ‘intemal standard solution— Dissolve a suitable quantily of USP Testosterone Propionte RS, accurately welghed, in methanol to obtain a solution having a concentration of about 1.2 mg per miOTOBRIGHT EAR DROPS INVET HEALTH CARE Ici EARDROFS dy umRiacaniiue DSIRICESRMOUR GIF) _Oflsin telomanone Dap, Caine i ‘Standard preparation— Dissolve a sulable quantiy of USP Beclomethasone Digropionate RS, ‘ccurately weighed. in methane to obtain a solution having @ concentration of about 1.4 mg per mL. ‘Transfer 4.0 ml of this solution to a sultable val, end add 4.0 mL of Internal standard solution to obtain 2 solution having a known concentration of about 0.7 mg per ml. with respect to the Reference Standard and 0.6 mg per mL with respect to the internal standard. ‘Assay proparation— Weigh accurately about 70 mg of Beclomethasone Dipropionate, transfer to a 50- ‘mL volumetric flask, dilute with methanol fo volume, and mix, Transfer 4.0 mLof this solution to a ‘suitable vial, and add 4.0 ml. of Infernal stand solution. Procedure— Separately inject equal volumes (between § il and 25 iL) of the Assay preparation and the Stanord preparation into a high-performance iquid chromatograph (see Chromatcaraphy { 621") ‘operated at roam temperature, adusting the specimen size and other operating parameters such that the peak obtained with the internal standard in the Standard preparation is about 0.8 to 0.9 ful-scale. ‘Typically, the apparatus is ited with a 4-mm x 30-em eelumn that contains packing L1 and is equipped with an UV detector sapable of monitoring absorption at 254 nm, a suitable recorder, and a pump capable of operating at column pressure of up to 3800 psl. In a suitable chromatogram, the Coefficient of variation for fve replcata injections of the Standard preparation is not more than 3.0%. Calculate the quantity, in mg. of CaHCiO, in the portion of Beclomethasone Dipropionate taken by the formu: 10001.) In which Cis the concentration, in mg per mi, of USP Beclomethasone Dipropionate RS in the ‘Standard preparation; and Ry and R. are the peak height ratios of beclomethasone dipropionate to the intemal standard obtained from the Assay preparation and the Standard preparation, respectively ‘Auxiliary information— Staff Liaison : Danis K. Bempong, Ph.D., Senior Scientist Expert Committee: (MDPS05) Monograph Developmani-Pulmonary and Steroids USP30-NF25 Page 1487 Phone Number: 1-301-816-8143