{"id":18794,"date":"2025-10-24T09:53:05","date_gmt":"2025-10-24T02:53:05","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=18794"},"modified":"2025-10-24T10:05:46","modified_gmt":"2025-10-24T03:05:46","slug":"nicotine-inhalation-cartridges","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nicotine-inhalation-cartridges\/","title":{"rendered":"Nicotine Inhalation Cartridges"},"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 Inhalation Cartridges are nicotine-impregnated plugs for use with a suitable mouthpiece.<\/p>\n<p>The inhalation cartridges comply with the requirements stated under Oromucosal 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>IDENTIFICATION<\/h2>\n<p>To a quantity of cartridges containing 20 mg of Nicotine add 10 mL of chloroform, extract with the aid of ultrasound, centrifuge for 10 minutes and filter through a 0.7-\u03bcm glass filter. Cool the mixture, add two 3-mL quantities of 0.5M hydrochloric acid and mix carefully. Centrifuge 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<br \/>\n(RS 452).<\/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 in 0.2M potassium dihydrogen orthophosphate adjusted to pH 2.0 with orthophosphoric acid (solvent A).<\/p>\n<p>(1) To a quantity of cartridges containing 20 mg of Nicotine add 50 mL of solvent A, extract with the aid of ultrasound and filter through a 0.7-\u03bcm glass filter.<\/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-18799\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Inhalation-Cartridges-300x163.jpg\" alt=\"Nicotine Inhalation Cartridges\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Inhalation-Cartridges-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Inhalation-Cartridges-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Inhalation-Cartridges-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nicotine-Inhalation-Cartridges.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 the peaks due to cotinine and trans-nicotine-1\u2032-oxide 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 0.6 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 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 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 secondary peaks is not greater than 5 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 adjusted to pH 2.0 with orthophosphoric acid (solvent A).<\/p>\n<p>(1) To a quantity of cartridges 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.<\/p>\n<p>(3) 0.004% 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 (3), the resolution between the peaks due to cotinine and trans-nicotine-1\u2032-oxide is at least 2.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the total content of nicotine, C<sub>10<\/sub>H<sub>14<\/sub>N<sub>2<\/sub>, in the cartridges 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 Inhalation Cartridges are nicotine-impregnated plugs for use with a suitable mouthpiece. The inhalation cartridges comply with the requirements stated under Oromucosal Preparations and with the following requirements. Content of nicotine, C10H14N2 95.0 to 105.0% of the stated amount. Carry out all of the&#8230;<\/p>\n","protected":false},"author":2,"featured_media":18798,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175,1],"tags":[],"class_list":["post-18794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs","category-volumes-1-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18794","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=18794"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18794\/revisions"}],"predecessor-version":[{"id":18824,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18794\/revisions\/18824"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/18798"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=18794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=18794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=18794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}