{"id":16911,"date":"2025-10-21T13:57:28","date_gmt":"2025-10-21T06:57:28","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16911"},"modified":"2025-10-21T13:57:28","modified_gmt":"2025-10-21T06:57:28","slug":"isoprenaline-hydrochloride","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/isoprenaline-hydrochloride\/","title":{"rendered":"Isoprenaline Hydrochloride"},"content":{"rendered":"

(Ph. Eur. monograph 1332)<\/em><\/p>\n

C11<\/sub>H18<\/sub>ClNO3<\/sub> 247.7 51-30-9<\/p>\n

Action and use<\/strong><\/p>\n

Adrenoceptor agonist.<\/p>\n

Preparation<\/strong><\/p>\n

Isoprenaline Injection<\/p>\n

DEFINITION<\/h2>\n

(1RS)-1-(3,4-Dihydroxyphenyl)-2-[(1-methylethyl)amino]ethanol hydrochloride.<\/p>\n

Content<\/h3>\n

98.0 per cent to 101.5 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\n

Freely soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in methylene chloride.<\/p>\n

IDENTIFICATION<\/h2>\n

First identification: B, C, E.<\/p>\n

Second identification: A, C, D, E.<\/p>\n

A. Melting point (2.2.14): 165 \u00b0C to 170 \u00b0C, with decomposition.<\/p>\n

B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison: isoprenaline hydrochloride CRS.<\/p>\n

C. Optical rotation (see Tests).<\/p>\n

D. To 0.1 mL of solution S (see Tests) add 0.05 mL of ferric chloride solution R1 and 0.9 mL of water R. A green colour is produced. Add dropwise sodium hydrogen carbonate solution R. The colour becomes blue and then red.<\/p>\n

E. To 0.5 mL of solution S add 1.5 mL of water R. The solution gives reaction (a) of chlorides (2.3.1).<\/p>\n

TESTS<\/h2>\n

Prepare the solutions immediately before use.<\/p>\n

Solution S<\/h3>\n

Dissolve 2.5 g in carbon dioxide-free water R and dilute to 25.0 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n

Solution S is clear (2.2.1) and not more intensely coloured than reference solution B7 or BY7 (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/h3>\n

4.3 to 5.5.<\/p>\n

Mix 5 mL of solution S and 5 mL of carbon dioxide-free water R.<\/p>\n

Optical rotation (2.2.7)<\/h3>\n

-0.10\u00b0 to + 0.10\u00b0, determined on solution S.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29).<\/p>\n

Test solution: Dissolve 50.0 mg of the substance to be examined in the mobile phase and dilute to 10.0 mL with the mobile phase.<\/p>\n

Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 5.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n

Reference solution (b): Dissolve 2.5 mg of orciprenaline sulfate CRS in the mobile phase and dilute to 100 mL with the mobile phase.<\/p>\n

Reference solution (c): To 5 mL of reference solution (a) add 5 mL of reference solution (b).<\/p>\n

Reference solution (d): Dissolve 6.0 mg of isoprenaline impurity A CRS in the mobile phase and dilute to 50.0 mL with the mobile phase. Dilute 10.0 mL of the solution to 50.0 mL with the mobile phase.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.125 m, \u00d8 = 4.0 mm;<\/p>\n

\u2014 stationary phase: octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n

Mobile phase: methanol R, 11.5 g\/L solution of phosphoric acid R (5:95 V\/V).<\/p>\n

Flow rate: 1.0 mL\/min.<\/p>\n

Detection: Spectrophotometer at 280 nm.<\/p>\n

Injection: 20 \u03bcL.<\/p>\n

Run time: 7 times the retention time of isoprenaline.<\/p>\n

Identification of impurities: Use the chromatogram obtained with reference solution (d) to identify the peak due to impurity A; use the chromatogram obtained with reference solution (b) to identify the peak due to orciprenaline.<\/p>\n

Relative retention: With reference to isoprenaline (retention time = about 4 min): orciprenaline = about 1.5; impurity A = about 1.8. If necessary, adjust the concentration of methanol in the mobile phase.<\/p>\n

System suitability: Reference solution (c):<\/p>\n

\u2014 resolution: minimum 3.0 between the peaks due to isoprenaline and orciprenaline.<\/p>\n

Limits:<\/p>\n

\u2014 impurity A: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (d) (0.5 per cent);<\/p>\n

\u2014 unspecified impurities: for each impurity, not more than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n

\u2014 total: maximum 1.0 per cent;<\/p>\n

\u2014 disregard limit: 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n

Loss on drying (2.2.32)<\/h3>\n

Maximum 1.0 per cent, determined on 1.000 g by drying in vacuo at 15-25 \u00b0C for 4 h.<\/p>\n

Sulfated ash (2.4.14)<\/h3>\n

Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n

In order to avoid overheating in the reaction medium, mix thoroughly throughout and stop the titration immediately after the end-point has been reached.<\/p>\n

Dissolve 0.150 g in 10 mL of anhydrous formic acid R and add 50 mL of acetic anhydride R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n

1 mL of 0.1 M perchloric acid is equivalent to 24.77 mg of C11<\/sub>H18<\/sub>ClNO3<\/sub>.<\/p>\n

STORAGE<\/h2>\n

In an airtight container, protected from light.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities A.<\/p>\n

\"Isoprenaline<\/p>\n

A. 1-(3,4-dihydroxyphenyl)-2-[(1-methylethyl)amino]ethanone.<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 1332) C11H18ClNO3 247.7 51-30-9 Action and use Adrenoceptor agonist. Preparation Isoprenaline Injection DEFINITION (1RS)-1-(3,4-Dihydroxyphenyl)-2-[(1-methylethyl)amino]ethanol hydrochloride. Content 98.0 per cent to 101.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Freely soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. IDENTIFICATION First…<\/p>\n","protected":false},"author":4,"featured_media":16928,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-16911","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16911","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=16911"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16911\/revisions"}],"predecessor-version":[{"id":16938,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16911\/revisions\/16938"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16928"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16911"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16911"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16911"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}