Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Anticholinergic.<\/p>\n Glycopyrronium Bromide Oral Solution is a solution of Glycopyrronium Bromide in a suitable flavoured vehicle.<\/p>\n The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Where appropriate, the oral solution also complies with the requirements stated under Unlicensed Medicines.<\/em><\/p>\n Content of glycopyrronium bromide, C19<\/sub>H28<\/sub>BrNO3<\/sub><\/strong><\/p>\n 90.0 to 110.0% of the stated amount.<\/p>\n A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in water.<\/p>\n (1) Dilute a volume of the oral solution, if necessary, to produce a solution containing 0.01% w\/v of Glycopyrronium Bromide.<\/p>\n (2) 0.01% w\/v of glycopyrronium bromide BPCRS.<\/p>\n (3) Equal volumes of solutions (1) and (2).<\/p>\n (a) Use as the coating silica gel (Merck silica gel 60 plates are suitable).<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 30 \u00b5L of each solution.<\/p>\n (d) Develop the plate to 15 cm.<\/p>\n (e) After removal of the plate, dry in air, spray with a solution containing 10 volumes of potassium iodide solution, 10 volumes of potassium iodobismuthate solution, 12 volumes of glacial acetic acid and 67 volumes of water.<\/p>\n 20 volumes of glacial acetic acid, 20 volumes of water and 60 volumes of butan-1-ol.<\/p>\n The test is not valid unless the chromatogram obtained with solution (3) appears as a single, compact spot.<\/p>\n The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n B. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the principal peak in the chromatogram obtained with solution (2).<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/p>\n (1) Dilute a quantity of the oral solution, if necessary, to produce a solution containing 0.01% w\/v of Glycopyrronium Bromide.<\/p>\n (2) 0.01% w\/v of glycopyrronium bromide BPCRS.<\/p>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (3 \u00b5m) (Inertsil ODS-3 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 215 nm.<\/p>\n (f) Inject 20 \u00b5L of each solution.<\/p>\n Dissolve 0.25 g of sodium heptanesulfonate in 615 mL of a 0.163% w\/v solution of anhydrous sodium sulfate; add 3 mL of a 0.515% w\/v solution of sulfuric acid, 150 mL of methanol R2 and 235 mL of acetonitrile R1.<\/p>\n The Assay is not valid unless the symmetry factor of the principal peak in the chromatogram obtained with solution (2) is between 0.8 and 2.0.<\/p>\n Calculate the content of C19<\/sub>H28<\/sub>BrNO3<\/sub> in the oral solution using the declared content of C19<\/sub>H28<\/sub>BrNO3<\/sub> in glycopyrronium bromide BPCRS.<\/p>\n Glycopyrronium Bromide Oral Solution should be protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Anticholinergic. DEFINITION Glycopyrronium Bromide Oral Solution is a solution of Glycopyrronium Bromide in a suitable flavoured vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Where appropriate, the oral solution also complies with the requirements stated under…<\/p>\n","protected":false},"author":5,"featured_media":16216,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-16213","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\/16213","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=16213"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16213\/revisions"}],"predecessor-version":[{"id":16218,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16213\/revisions\/16218"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16216"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16213"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16213"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16213"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
CONFIRMATION<\/h3>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
STORAGE<\/h2>\n