Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
General Notices<\/p>\n
Action and use<\/p>\n
Skeletal muscle relaxant.<\/p>\n
Baclofen Oral Solution is a solution of Baclofen in a suitable aqueous vehicle.<\/p>\n
The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n
Content of baclofen, C10H12ClNO2<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in a mixture of 35 volumes of acetonitrile and 65 volumes of water.<\/p>\n (1) Dilute a volume of the oral solution containing 5 mg of Baclofen to 100 mL.<\/p>\n (2) 0.005% w\/v of baclofen BPCRS.<\/p>\n (a) Use as the coating silica gel G.<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 5 \u03bcL of each solution.<\/p>\n (d) Develop the plate to 10 cm.<\/p>\n (e) After removal of the plate, dry in air.<\/p>\n (f) Place an evaporating dish containing 4 mL of water, 1 mL of 7M hydrochloric acid and 0.5 g of potassium permanganate in a chromatography tank, close the tank and allow to stand for 2 minutes. Place the plate in the tank, close the tank and leave the plate in contact with the vapour for 1 minute.<\/p>\n (g) After removal of the plate, place it in a current of cold air until an area of coating below the line of application shows only a faint blue colour on the addition of 0.05 mL of potassium iodide and starch solution. Spray the plate with potassium iodide and starch solution and examine in daylight.<\/p>\n 20 volumes of glacial acetic acid, 20 volumes of water and 80 volumes of butan-1-ol.<\/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 chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n Impurity A<\/strong><\/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 weighed quantity of the oral solution containing 5 mg of Baclofen to 50 mL.<\/p>\n (2) 0.0002% w\/v of baclofen impurity A EPCRS.<\/p>\n (3) 0.01% w\/v of baclofen BPCRS, 0.0003% w\/v of propyl 4-hydroxybenzoate, 0.0003% w\/v of methyl 4-hydroxybenzoate and 0.0002% w\/v of baclofen impurity A EPCRS.<\/p>\n The chromatographic conditions described under Assay may be used.<\/p>\n 5 g of sodium dodecyl sulfate in a mixture of 5 mL of orthophosphoric acid and 650 mL of water and diluted to 1000 mL with acetonitrile R1.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to methyl-4-hydroxybenzoate and impurity A (lactam) and between the peaks due to impurity A and propyl-4-hydroxybenzoate is at least 5.0.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (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 weighed quantity of the oral solution containing 5 mg of Baclofen to 50 mL.<\/p>\n (2) 0.01% w\/v of baclofen BPCRS.<\/p>\n (3) 0.01% w\/v of baclofen BPCRS, 0.0003% w\/v of propyl 4-hydroxybenzoate and 0.0002% w\/v of baclofen impurity A EPCRS.<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatograph (10 \u03bcm) (Nucleosil C18 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.5 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 218 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n 5 g of sodium dodecyl sulfate in a mixture of 5 mL of orthophosphoric acid and 650 mL of water and diluting to 1000 mL with acetonitrile R1.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity A and propyl-4-hydroxybenzoate is at least 5.0.<\/p>\n Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C10H12ClNO2, weight in volume, using the declared content of C10H12ClNO2 in baclofen BPCRS.<\/p>\n Baclofen Oral Solution should be stored below 25\u00b0 and protected from light. It should not be refrigerated.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Action and use Skeletal muscle relaxant. DEFINITION Baclofen Oral Solution is a solution of Baclofen in a suitable aqueous vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of baclofen, C10H12ClNO2 95.0 to 105.0% of the stated…<\/p>\n","protected":false},"author":5,"featured_media":3849,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-3847","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\/3847","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=3847"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/3847\/revisions"}],"predecessor-version":[{"id":5744,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/3847\/revisions\/5744"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/3849"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=3847"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=3847"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=3847"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
CONFIRMATION<\/h3>\n
TESTS<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
LIMITS<\/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