Adrenoceptor agonist + local anaesthetic.<\/p>\n
DEFINITION<\/h2>\n
Adrenaline and Cocaine Intranasal Solution contains Adrenaline Acid Tartrate and Cocaine Hydrochloride in a suitable vehicle.<\/p>\n
The intranasal solution complies with the requirements stated under Nasal Preparations and with the following requirements. Where appropriate, the intranasal solution also complies with the requirements stated under Unlicensed Medicines.<\/p>\n
Content of adrenaline, C9<\/sub>H13<\/sub>NO3<\/sub><\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n Content of cocaine hydrochloride, C17<\/sub>H21<\/sub>NO4<\/sub>,HCl<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A. In the Assay for adrenaline, the principal peak in the chromatogram obtained with solution (1) has the same retention time as that in the chromatogram obtained with solution (2).<\/p>\n B. In the Assay for cocaine hydrochloride, the principal peak in the chromatogram obtained with solution (1) has the same retention time as that in the chromatogram obtained with solution (2).<\/p>\n C. To 10 ml of the intranasal solution add 2 mL of a 10% w\/v solution of disodium hydrogen orthophosphate and sufficient iodinated potassium iodide solution to produce a brown colour and remove excess iodine by adding 0.1M sodium thiosulfate drop wise. A red colour is produced.<\/p>\n D. Yields reaction A characteristic of chlorides, Appendix VI.<\/p>\n pH, 2.0 to 4.0, Appendix V L.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dilute a volume of the intranasal solution with sufficient mobile phase to produce a solution containing 0.04% w\/v of Cocaine Hydrochloride.<\/p>\n (2) 0.0008% w\/v of benzoylecgonine hydrate in the mobile phase.<\/p>\n (3) 0.0008% w\/v of benzoic acid in the mobile phase.<\/p>\n (4) 0.0008% w\/v of each of benzoylecgonine hydrate and benzoic acid in solution (1).<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (10 \u03bcm) (Partisil 10 ODS is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 240 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n 1 volume of 9M perchloric acid, 35 volumes of methanol and 64 volumes of water.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks corresponding to benzoylecgonine and benzoic acid is at least 2.0.<\/p>\n LIMITS<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to benzoylecgonine is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2%);<\/p>\n the area of any peak corresponding to benzoic acid is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (2%).<\/p>\n The total impurity content is not greater than 2%.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dilute a suitable volume of the intranasal solution with sufficient mobile phase to produce a solution containing the equivalent of 0.011% w\/v of adrenaline.<\/p>\n (2) 0.02% w\/v of adrenaline acid tartrate BPCRS in the mobile phase.<\/p>\n (3) 0.02% w\/v of adrenaline acid tartrate BPCRS and 0.02% w\/v of noradrenaline acid tartrate in the mobile phase.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \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 2 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 205 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n Dissolve 4.0 g of tetramethylammonium hydrogen sulfate, 1.1 g of sodium heptanesulfonate and 2 mL of 0.1M disodium edetate in a mixture of 950 mL of water and 50 mL of methanol and adjust the pH to 3.5 with 1M sodium hydroxide.<\/p>\n SYSTEM SUITABILITY<\/p>\n The assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 2.0.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of C9<\/sub>H13<\/sub>NO3<\/sub> in the intranasal solution from the chromatograms obtained and using the declared content of C9<\/sub>H13<\/sub>NO3<\/sub> in adrenaline acid tartrate BPCRS.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dilute a volume of the intranasal solution containing 40 mg of Cocaine Hydrochloride with sufficient water to produce 100 mL.<\/p>\n (2) 0.04% w\/v of cocaine hydrochloride BPCRS in water.<\/p>\n (3) 0.0008% w\/v of each of benzoylecgonine hydrate and benzoic acid in solution (1).<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (10 \u03bcm) (Partisil 10 ODS is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 240 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n 1 volume of 9M perchloric acid, 35 volumes of methanol and 64 volumes of water.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to benzoylecgonine and benzoic acid is at least 2.0.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of C17<\/sub>H21<\/sub>NO4<\/sub>,HCl in the intranasal solution from the chromatograms obtained and using the declared content of C17<\/sub>H21<\/sub>NO4<\/sub>,HCl in cocaine hydrochloride BPCRS.<\/p>\n Adrenaline and Cocaine Intranasal Solution should be protected from light.<\/p>\n The quantity of adrenaline acid tartrate is stated in terms of the equivalent amount of adrenaline (epinephrine).<\/p>\n The impurities limited by the requirements of this monograph include:<\/p>\n <\/p>\n 1. Benzoylecgonine,<\/p>\n <\/p>\n 2. Benzoic acid.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Adrenoceptor agonist + local anaesthetic. DEFINITION Adrenaline and Cocaine Intranasal Solution contains Adrenaline Acid Tartrate and Cocaine Hydrochloride in a suitable vehicle. The intranasal solution complies with the requirements stated under Nasal Preparations and with the following requirements. Where appropriate, the intranasal solution also complies…<\/p>\n","protected":false},"author":5,"featured_media":2710,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-2619","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\/2619","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=2619"}],"version-history":[{"count":8,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2619\/revisions"}],"predecessor-version":[{"id":5317,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2619\/revisions\/5317"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/2710"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=2619"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=2619"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=2619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Acidity<\/h3>\n
Related substances (for cocaine hydrochloride)<\/h3>\n
ASSAY<\/h2>\n
For adrenaline<\/h3>\n
For cocaine hydrochloride<\/h3>\n
STORAGE<\/h2>\n
LABELLING<\/h2>\n
IMPURITIES<\/h3>\n
![\"Benzoylecgonine\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Benzoylecgonine-0.jpg\")
<\/p>\n![\"Benzoic](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Benzoic-acid-0.jpg\")
<\/p>\n