{"id":18801,"date":"2025-10-24T10:06:07","date_gmt":"2025-10-24T03:06:07","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=18801"},"modified":"2025-11-15T16:43:49","modified_gmt":"2025-11-15T09:43:49","slug":"nicotine-nasal-spray","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nicotine-nasal-spray\/","title":{"rendered":"Nicotine Nasal Spray"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Central nervous system stimulant; nicotine replacement therapy.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Nicotine Nasal Spray is a solution of Nicotine containing suitable buffering agents in a suitable container fitted with a suitable nasal delivery system.<\/p>\n<p>The nasal spray complies with the requirements stated under Nasal Preparations and with the following requirements.<\/p>\n<h3>Content of nicotine, C<sub>10<\/sub>H<sub>14<\/sub>N<sub>2<\/sub><\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<p>Carry out all of the following procedures protected from light.<\/p>\n<h2>CHARACTERISTICS<\/h2>\n<p>Colourless or brownish solution.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>To a volume of the nasal spray containing 20 mg of Nicotine add 5 mL of chloroform, dissolve with the aid of ultrasound and centrifuge for 10 minutes. Cool the mixture, add two 3-mL quantities of 0.5M hydrochloric acid and mix carefully. Centrifuge the mixture for 10 minutes. Transfer 5 mL of the aqueous layer to a separating funnel and add sufficient 0.5M sodium hydroxide to obtain a pH of 10.5, add 3 mL of chloroform, shake and retain the chloroform layer. The infrared absorption spectrum of the solution, Appendix II A, is concordant with the reference spectrum of nicotine (RS 452).<\/p>\n<h2>TESTS<\/h2>\n<h3>Acidity or alkalinity<\/h3>\n<p>pH, 6.7 to 7.3, Appendix V L.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 0.2M potassium dihydrogen orthophosphate adjusted to pH 2.0 with orthophosphoric acid (solvent A).<\/p>\n<p>(1) Dilute a volume of the nasal spray containing 20 mg of Nicotine to 50 mL with solvent A and mix.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n<p>(3) Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n<p>(4) 0.04% w\/v of nicotine impurity standard BPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped polar-embedded octadecylsilyl amorphous organosilica polymer (3.5 \u03bcm) (Waters XBridge is suitable) fitted with a guard column (3 cm \u00d7 4.6 mm) packed with the same material.<\/p>\n<p>(b) Use gradient 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 254 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>Mobile phase A: Add 25 volumes of 1M acetic acid to 1000 volumes of water, add 6.2 volumes of 18M ammonia and adjust the pH to 10 with 18M ammonia.<\/p>\n<p>Mobile phase B: acetonitrile.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-18815\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Nasal-Spray-1-300x163.jpg\" alt=\"Nicotine Nasal Spray\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Nasal-Spray-1-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Nasal-Spray-1-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Nasal-Spray-1-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Nasal-Spray-1.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>In the chromatogram obtained with solution (4):<\/p>\n<p>identify the peaks due to cotinine, myosmine, cis-nicotine-1\u2032-oxide and trans-nicotine-1\u2032-oxide.<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>Identify any peak corresponding to cis-nicotine-1\u2032-oxide and multiply the area of this peak by a correction factor of 1.5;<\/p>\n<p>identify any peak corresponding to trans-nicotine-1\u2032-oxide and multiply the area of this peak by a correction factor of 1.5.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between trans-nicotine-1\u2032-oxide and cotinine is at least 2.0.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peak corresponding to cotinine is not greater than 0.6 times the area of the principal peak in the chromatogram obtained with solution (2) (0.6%);<\/p>\n<p>the area of any peak corresponding to myosmine is not greater than 0.7 times the area of the principal peak in the chromatogram obtained with solution (2) (0.7%);<\/p>\n<p>the area of any peak corresponding to cis-nicotine-1\u2032-oxide is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (3.0%);<\/p>\n<p>the area of any peak corresponding to trans-nicotine-1\u2032-oxide is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (3.0%);<\/p>\n<p>the area of any other secondary peak is not greater than 0.2 times 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 other secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);<\/p>\n<p>the sum of the areas of all the secondary peaks is not greater than five times the area of the principal peak in the chromatogram obtained with solution (2) (5.0%).<\/p>\n<p>Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 0.2M potassium dihydrogen orthophosphate, the pH of which is adjusted to 2.0 with orthophosphoric acid (solvent A).<\/p>\n<p>(1) To a volume of the nasal spray containing 20 mg of Nicotine add 50 mL of solvent A and mix. Dilute 1 volume of the resulting solution to 10 volumes.<\/p>\n<p>(2) 0.0124% w\/v of nicotine ditartrate dihydrate BPCRS in solvent A<\/p>\n<p>(3) 0.04% w\/v of nicotine impurity standard BPCRS in solvent A.<\/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 (4), the resolution between trans-nicotine-1\u2032-oxide and cotinine is at least 2.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the total content of C<sub>10<\/sub>H<sub>14<\/sub>N<sub>2<\/sub> in the nasal spray using the declared content of C<sub>10<\/sub>H<sub>14<\/sub>N<sub>2<\/sub> in nicotine ditartrate dihydrate BPCRS. Each mg of C<sub>10<\/sub>H<sub>14<\/sub>N<sub>2<\/sub> is equivalent to 3.074 mg of C<sub>10<\/sub>H<sub>14<\/sub>N<sub>2<\/sub>,C<sub>8<\/sub>H<sub>12<\/sub>O<sub>12<\/sub>,2H<sub>2<\/sub>O.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed under Nicotine.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Central nervous system stimulant; nicotine replacement therapy. DEFINITION Nicotine Nasal Spray is a solution of Nicotine containing suitable buffering agents in a suitable container fitted with a suitable nasal delivery system. The nasal spray complies with the requirements stated under Nasal Preparations and with the following requirements. Content of nicotine, C10H14N2 95.0&#8230;<\/p>\n","protected":false},"author":2,"featured_media":18816,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-18801","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\/18801","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=18801"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18801\/revisions"}],"predecessor-version":[{"id":32198,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18801\/revisions\/32198"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/18816"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=18801"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=18801"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=18801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}