(Ph. Eur. 11.6 update)<\/p>\n
Beclometasone Powder for Inhalation, pre-dispensed<\/p>\n
Action and use<\/strong><\/p>\n Glucocorticoid.<\/p>\n Beclometasone Inhalation Powder, pre-metered consists of Beclometasone Dipropionate or Beclometasone Dipropionate Monohydrate in microfine powder either alone or combined with a suitable carrier. The pre-metered unit is loaded into a dry-powder inhaler to generate an aerosol.<\/p>\n The inhalation powder, pre-metered complies with the requirements stated under Preparations for Inhalation and with the following requirements.<\/p>\n The size of aerosol particles to be inhaled is controlled so that a consistent portion is deposited in the lungs. The fine-particle characteristics of preparations for inhalation are determined using the method described in Appendix XII C7. Preparations for inhalation: Aerodynamic Assessment of Fine Particles. The test and limits should be agreed with the competent authority.<\/p>\n The water content is controlled to ensure the performance of the product as justified and authorised by the competent authority.<\/p>\n Content of beclometasone dipropionate, C28<\/sub>H37<\/sub>ClO7<\/sub><\/strong><\/p>\n When supplied as disks, 90.0 to 110.0% of the stated amount per pre-metered unit. When supplied as capsules, 80.0 to 120.0% of the stated amount per pre-metered unit.<\/p>\n A. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n B. Disperse a quantity of powder, containing the equivalent of 200 \u03bcg of beclometasone dipropionate in 5 mL of 1M sodium hydroxide in a 25 mL conical flask. Add three drops of copper sulfate solution and shake. A precipitate may form which dissolves to give a clear blue solution. Heat the solution to boiling; a red precipitate is produced.<\/p>\n C. For products containing lactose disperse 0.25 g of the powder for inhalation in 5 mL of water. Add 5 mL of 6M ammonia and heat in a water-bath at 80\u00b0 for 10 minutes. An orange-red colour is produced.<\/p>\n Complies with the requirements stated under Inhalation Powders using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Collect single doses of the preparation being examined using the procedure described under Inhalation Powders, Uniformity of delivered dose and dissolve the collected dose in sufficient of a mixture of 45 volumes of water and 55 volumes of acetonitrile to produce a solution containing the equivalent of 0.00005% w\/v of beclometasone dipropionate.<\/p>\n (2) Dilute 10 mL of a solution containing 0.0005% w\/v of beclometasone dipropionate BPCRS in methanol to 100 mL with a mixture of 45 volumes of water and 55 volumes of acetonitrile.<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octylsilyl silica gel for chromatography (5 \u03bcm) (Lichrospher 60 RP-select B is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.3 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 240 nm.<\/p>\n (f) Inject 100 \u03bcL of each solution.<\/p>\n 25 volumes of water and 75 volumes of methanol.<\/p>\n Calculate the content of beclometasone dipropionate, C28<\/sub>H37<\/sub>ClO7<\/sub>, per delivered dose using the declared content of C28<\/sub>H37<\/sub>ClO7 <\/sub>in beclometasone dipropionate BPCRS. Repeat the procedure as described for pre-metered systems under Inhalation Powders, Uniformity of delivered dose.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dissolve a quantity of the mixed contents of 20 units containing the equivalent of 1.2 mg of beclometasone dipropionate in the mobile phase and dilute to 5 mL with the mobile phase.<\/p>\n (2) Dilute 1 volume of solution (1) to 100 volumes with the mobile phase.<\/p>\n (3) 0.0040% w\/v each of beclometasone 17-propionate BPCRS and beclometasone 21-propionate BPCRS in the mobile phase.<\/p>\n (4) Dilute 1 volume of solution (2) to 20 volumes with the mobile phase.<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Lichrosorb RP18 or Lichrospher RP18 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 254 nm.<\/p>\n (f) Inject 100 \u03bcL of each solution.<\/p>\n (g) For solutions (1) and (2) allow the chromatography to proceed for twice the retention time of the principal peak.<\/p>\n Dilute 60 volumes of acetonitrile to 100 volumes with water.<\/p>\n When the chromatograms are recorded under the prescribed conditions, the retention time for beclometasone 17-propionate is about 6 minutes, for beclometasone 21-propionate, about 7 minutes and for beclometasone dipropionate, about 13 minutes.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to beclometasone 17-propionate and beclometasone 21-propionate is at least 1.4. If necessary adjust the concentration of acetonitrile in the mobile phase.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%);<\/p>\n not more than one such secondary peak has an area greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n the sum of the areas of all the secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).<\/p>\n Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.05%).<\/p>\n Weigh and powder the contents of 20 pre-dispensed units. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dissolve a quantity of the mixed contents of the pre-dispensed unit in sufficient of the mobile phase to produce a solution containing the equivalent of 0.001% w\/v of beclometasone dipropionate.<\/p>\n (2) 0.001% w\/v of beclometasone dipropionate BPCRS in the mobile phase.<\/p>\n (3) 0.001% w\/v each of beclometasone 17-propionate BPCRS and beclometasone 21-propionate BPCRS in the mobile phase.<\/p>\n The chromatographic conditions described under Related substances may be used.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to beclometasone 17-propionate and beclometasone 21-propionate is at least 1.4. If necessary adjust the concentration of acetonitrile in the mobile phase.<\/p>\n Calculate the content of C28<\/sub>H37<\/sub>ClO7 <\/sub>using the declared content of C28<\/sub>H37<\/sub>ClO7 <\/sub>in beclometasone dipropionate BPCRS.<\/p>\n The quantity of active ingredient is stated in terms of the equivalent amount of beclometasone dipropionate.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) Beclometasone Powder for Inhalation, pre-dispensed Action and use Glucocorticoid. DEFINITION Beclometasone Inhalation Powder, pre-metered consists of Beclometasone Dipropionate or Beclometasone Dipropionate Monohydrate in microfine powder either alone or combined with a suitable carrier. The pre-metered unit is loaded into a dry-powder inhaler to generate an aerosol. The inhalation powder, pre-metered complies…<\/p>\n","protected":false},"author":5,"featured_media":6206,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-6202","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6202","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=6202"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6202\/revisions"}],"predecessor-version":[{"id":6214,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6202\/revisions\/6214"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/6206"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=6202"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=6202"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=6202"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
PRODUCTION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Uniformity of delivered dose<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
DETERMINATION OF CONTENT<\/h4>\n
Related substances<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
SYSTEM SUITABILITY<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
LABELLING<\/h2>\n