{"id":6484,"date":"2025-09-30T15:35:53","date_gmt":"2025-09-30T08:35:53","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=6484"},"modified":"2025-09-30T15:35:53","modified_gmt":"2025-09-30T08:35:53","slug":"caffeine-citrate-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/caffeine-citrate-oral-solution\/","title":{"rendered":"Caffeine Citrate Oral Solution"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p>Action and use<\/p>\n<p>Respiratory and central nervous system stimulant.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Caffeine Citrate Oral Solution is a solution of caffeine citrate, prepared by the interaction of Caffeine and Citric Acid Monohydrate, in a suitable aqueous vehicle. Sodium citrate may also be present.<\/p>\n<p>The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n<p>Content of caffeine citrate, C<sub>8<\/sub>H<sub>10<\/sub>N<sub>4<\/sub>O<sub>2<\/sub>,C<sub>6<\/sub>H<sub>8<\/sub>O<sub>7<\/sub><br \/>\n95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A.\u2003Carry out the method for thin-layer chromatography, Appendix III A, using the following solution preparing a mixture containing 2 volumes of methanol and 3 volumes of dichloromethane.<br \/>\n(1)\u2003Dilute a volume of the oral solution containing the equivalent of 10 mg of caffeine to 100 mL.<br \/>\n(2)\u20030.01% w\/v of caffeine BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a)\u2003Use as the coating silica gel F254.<br \/>\n(b)\u2003Use the mobile phase as described below.<br \/>\n(c)\u2003Apply 10 \u00b5L of each solution.<br \/>\n(d)\u2003Develop the plate to 15 cm.<br \/>\n(e)\u2003After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>1 volume of concentrated ammonia, 3 volumes of acetone, 3 volumes of dichloromethane and 4 volumes of butan-1-ol.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>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<p>B.\u2003In the Assay, the chromatogram obtained with solution (1) shows a principal peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<p>C.\u2003Yields the reaction characteristic of citrates, Appendix VI.<\/p>\n<p><strong>Related substances<\/strong><\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in water.<\/p>\n<p>(1)\u2003Dilute a volume of the oral solution containing the equivalent of 50 mg caffeine to 250 mL and filter through a 0.45-\u00b5m filter.<br \/>\n(2)\u2003Dilute 1 volume of solution (1) to 100 volumes and dilute 1 volume of the resulting solution to 5 volumes.<br \/>\n(3)\u20030.02% w\/v each of theobromine, 1,7-dimethyl-3,7-dihydro-1H-purine-2,6-dione (impurity F), theophylline BPCRS and caffeine BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a)\u2003Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u00b5m) (Waters C18 is suitable).<br \/>\n(b)\u2003Use isocratic elution and the mobile phase described below.<br \/>\n(c)\u2003Use a flow rate of 1 mL per minute.<br \/>\n(d)\u2003Use an ambient column temperature.<br \/>\n(e)\u2003Use a detection wavelength of 275 nm.<br \/>\n(f)\u2003Inject 10 \u00b5L of each solution.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>4 volumes of tetrahydrofuran, 5 volumes of acetonitrile and 191 volumes of 0.01M anhydrous sodium acetate, previously adjusted to pH 4.5 with glacial acetic acid.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, the chromatogram obtained with solution (3) has 4 distinct peaks and the resolution between the peaks due to theophylline and caffeine is at least 6.0.<\/p>\n<h3>LIMITS<\/h3>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n<p>the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).<\/p>\n<p>Disregard any peak with an area less than 0.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in water.<\/p>\n<p>(1)\u2003Dilute a volume of the oral solution containing the equivalent of 50 mg caffeine to 250 mL and filter through a 0.45-\u00b5m filter.<br \/>\n(2)\u20030.02% w\/v of caffeine BPCRS.<br \/>\n(3)\u20030.02% w\/v each of theobromine, 1,7-dimethyl-3,7-dihydro-1H-purine-2,6-dione, theophylline BPCRS and caffeine BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Related substances may be used.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, the chromatogram obtained with solution (3) has 4 distinct peaks and the resolution between the peaks due to theophylline and caffeine is at least 6.0.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C8H10N4O2,C6H8O7 in the oral solution using the declared content of C8H10N4O2 in caffeine BPCRS.<br \/>\nEach mg of C8H10N4O2 is equivalent to 1.989 mg of C8H10N4O2,C6H8O7<\/p>\n<h2>LABELLING<\/h2>\n<p>The quantity of active ingredient is stated in terms of the amount of caffeine citrate and the equivalent amount of caffeine.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include impurities A, B, C, D and F listed under Caffeine.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Respiratory and central nervous system stimulant. DEFINITION Caffeine Citrate Oral Solution is a solution of caffeine citrate, prepared by the interaction of Caffeine and Citric Acid Monohydrate, in a suitable aqueous vehicle. Sodium citrate may also be present. The oral solution complies with the requirements&#8230;<\/p>\n","protected":false},"author":5,"featured_media":6503,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-6484","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\/6484","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=6484"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6484\/revisions"}],"predecessor-version":[{"id":6511,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6484\/revisions\/6511"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/6503"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=6484"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=6484"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=6484"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}