{"id":21153,"date":"2025-10-28T09:56:35","date_gmt":"2025-10-28T02:56:35","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=21153"},"modified":"2025-10-28T09:56:35","modified_gmt":"2025-10-28T02:56:35","slug":"rivastigmine-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/rivastigmine-oral-solution\/","title":{"rendered":"Rivastigmine Oral Solution"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Cholinesterase inhibitor; treatment of dementia in Alzheimer&#8217;s disease and Parkinson&#8217;s disease.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Rivastigmine Oral Solution contains Rivastigmine Hydrogen Tartrate in a suitable vehicle.<\/p>\n<p>The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n<h3>Content of rivastigmine, C<sub>14<\/sub>H<sub>22<\/sub>N<sub>2<\/sub>O<sub>2<\/sub><\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n<p>(1) Shake a volume of the oral solution containing the equivalent of 18 mg of rivastigmine with 25 mL of methanol. Add sufficient methanol to produce 50 mL and filter (a 0.45-\u03bcm Nylon filter is suitable).<\/p>\n<p>(2) 0.058% w\/v of rivastigmine hydrogen tartrate BPCRS in methanol.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use as the coating silica gel F254 (Merck silica gel 60 F254 plates are suitable).<\/p>\n<p>(b) Use the mobile phase as described below.<\/p>\n<p>(c) Apply 10 \u03bcL of each solution.<\/p>\n<p>(d) Develop the plate to 15 cm.<\/p>\n<p>(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n<p>MOBILE PHASE<\/p>\n<p>2 volumes of formic acid, 5 volumes of water, 30 volumes of methanol and 70 volumes of dichloromethane.<\/p>\n<p>CONFIRMATION<\/p>\n<p>The principal spot in the chromatogram obtained with solution (1) is similar in position and size to that in the chromatogram obtained with solution (2).<\/p>\n<p>B. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in the mobile phase. Prepare the solutions immediately before use and protect from light.<\/p>\n<p>(1) Shake a volume of the oral solution containing the equivalent of 25 mg of rivastigmine with 15 mL and add sufficient mobile phase to produce 50 mL.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes. Dilute 1 volume of the resulting solution to 5 volumes.<\/p>\n<p>(3) 0.1% w\/v of rivastigmine for system suitability EPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped polar-embedded octadecylsilyl amorphous organosilica polymer for chromatography (5 \u03bcm) (XTerra RP C18 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 1.0 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 217 nm.<\/p>\n<p>(f) Inject 10 \u03bcL of each solution.<\/p>\n<p>(g) Allow the chromatography to proceed for 3.5 times the retention time of rivastigmine.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>28 volumes of acetonitrile R1 and 72 volumes of 0.01M sodium heptanesulfonate, adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to rivastigmine (retention time about 7 minutes) are: impurity A, about 0.5; impurity B, about 0.7 and impurity C, about 2.5.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity A and impurity B is at least 7.0.<\/p>\n<p>LIMITS<\/p>\n<p>Identify any peak corresponding to impurity C in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and multiply the area of this peak by a correction factor of 0.6.<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peak corresponding to impurity A is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n<p>the area of any other 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 all the 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 half 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 prepared in the mobile phase and protected from light.<\/p>\n<p>(1) Shake a weighed quantity of the oral solution containing the equivalent of 10 mg of rivastigmine with 50 mL of mobile phase. Add sufficient mobile phase to produce 100 mL.<\/p>\n<p>(2) 0.016% w\/v of rivastigmine hydrogen tartrate BPCRS.<\/p>\n<p>(3) 0.1% w\/v of rivastigmine for system suitability EPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic conditions described under Related substances may be used.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity A and impurity B is at least 7.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C<sub>14<\/sub>H<sub>22<\/sub>N<sub>2<\/sub>O<sub>2<\/sub>, weight in volume, using the declared content of C<sub>18<\/sub>H<sub>28<\/sub>N<sub>2<\/sub>O<sub>8<\/sub> in rivastigmine hydrogen tartrate BPCRS. Each mg of C<sub>18<\/sub>H<sub>28<\/sub>N<sub>2<\/sub>O<sub>8<\/sub><br \/>\nis equivalent to 0.6251 mg of C<sub>14<\/sub>H<sub>22<\/sub>N<sub>2<\/sub>O<sub>2<\/sub><\/p>\n<h2>STORAGE<\/h2>\n<p>Rivastigmine Oral Solution should be protected from light. It should not be refrigerated or allowed to freeze.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include impurities A, B and C listed under Rivastigmine Hydrogen Tartrate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Cholinesterase inhibitor; treatment of dementia in Alzheimer&#8217;s disease and Parkinson&#8217;s disease. DEFINITION Rivastigmine Oral Solution contains Rivastigmine Hydrogen Tartrate in a suitable vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of rivastigmine, C14H22N2O2 95.0 to 105.0% of the stated amount. IDENTIFICATION A&#8230;.<\/p>\n","protected":false},"author":2,"featured_media":21170,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21153","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\/21153","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=21153"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21153\/revisions"}],"predecessor-version":[{"id":21172,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21153\/revisions\/21172"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21170"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21153"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21153"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21153"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}