{"id":29068,"date":"2025-11-10T14:22:38","date_gmt":"2025-11-10T07:22:38","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=29068"},"modified":"2025-11-10T14:23:52","modified_gmt":"2025-11-10T07:23:52","slug":"salbutamol","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/salbutamol\/","title":{"rendered":"Salbutamol"},"content":{"rendered":"

(Ph. Eur. monograph 0529)<\/p>\n

C_{13<\/sub>H_{21<\/sub>NO_{3\u00a0<\/sub> \u00a0 \u00a0 \u00a0239.3\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 18559-94-9<\/p>\n}}}

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

Beta2-adrenoceptor agonist; bronchodilator.<\/p>\n

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

Salbutamol Pressurised Inhalation<\/p>\n

DEFINITION<\/h2>\n
4-[(1RS)-2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol.<\/p>\n
Content<\/h3>\n
98.0 per cent to 101.0 per cent (dried substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Sparingly soluble in water, soluble in ethanol (96 per cent), very slightly soluble or practically insoluble in methylene chloride.<\/p>\n
mp<\/h3>\n
About 155 \u00b0C, with decomposition.<\/p>\n
IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: salbutamol CRS.<\/p>\n
TESTS<\/h2>\n
Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution BY_{5<\/sub> (2.2.2, Method II).\\<\/p>\n}
Dissolve 0.5 g in methanol R and dilute to 25 mL with the same solvent.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29). Protect the solutions from light.<\/p>\n
Test solution: Dissolve 20.0 mg of the substance to be examined in mobile phase A and dilute to 50.0 mL with mobile phase A.<\/p>\n
Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with mobile phase A. Dilute 1.0 mL of this solution to 10.0 mL with mobile phase A.<\/p>\n
Reference solution (b): Dissolve 2 mg of salbutamol for peak identification CRS (containing impurities C, F, N, O and P) in 5 mL of mobile phase A.<\/p>\n
Reference solution (c): Using sonication, dissolve the contents of a vial of salbutamol impurity J CRS in 1 mL of the test solution.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: end-capped solid core octylsilyl silica gel for<\/p>\n
chromatography R (2.7 \u03bcm);<\/p>\n
\u2014 temperature: 30 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: dissolve 3.45 g of sodium dihydrogen phosphate monohydrate R in about 900 mL of water for chromatography R and add 0.5 mL of triethylamine R; adjust to pH 3.0 with dilute phosphoric acid R and dilute to 1000 mL with water for chromatography R;<\/p>\n
\u2014 mobile phase B: methanol R, acetonitrile R (35:65 V\/V);<\/p>\n\n\n\n\n\n\n\n\n
Time<\/strong>
\n(min)<\/strong><\/td>\n Mobile phase A<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n Mobile phase B<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 5<\/td>\n 95<\/td>\n 5<\/td>\n<\/tr>\n
5 – 25<\/td>\n 95 \u2192 70<\/td>\n 5 \u2192 30<\/td>\n<\/tr>\n
25 – 27<\/td>\n 70<\/td>\n 30<\/td>\n<\/tr>\n
27 – 30<\/td>\n 70 \u2192 10<\/td>\n 30 \u2192 90<\/td>\n<\/tr>\n
30 – 35<\/td>\n 10<\/td>\n 90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.0 mL\/min.<\/p>\n
Detection: Spectrophotometer at 273 nm.<\/p>\n
Injection: 20 \u03bcL.<\/p>\n
Identification of impurities: Use the chromatogram supplied with salbutamol for peak identification CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities C, F, N, O and P; use the chromatogram obtained with reference solution (c) to identify the peak due to impurity J.<\/p>\n
Relative retention: With reference to salbutamol (retention time = about 5 min): impurity J = about 0.92; impurity C = about 2.3; impurity N (isomer 1) = about 2.84; impurity N (isomer 2) = about 2.86; impurity P = about 2.91; impurity F = about 3.03; impurity O = about 3.07.<\/p>\n
System suitability:<\/p>\n
\u2014 resolution: minimum 1.5 between the peaks due to impurities F and O in the chromatogram obtained with reference solution (b);<\/p>\n
\u2014 peak-to-valley ratio: minimum 2.0, where H_{p<\/sub> = height above the baseline of the peak due to impurity J and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to salbutamol in the chromatogram obtained with reference solution (c); minimum 2.0, where H_{p<\/sub> = height above the baseline of the peak due to impurity N (isomer 1) and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity N (isomer 2) in the chromatogram obtained with reference solution (b); minimum 2.0, where H_{p <\/sub>= height above the baseline of the peak due to impurity N (isomer 2) and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity P in the chromatogram
\nobtained with reference solution (b).<\/p>\n}}}}}}
Calculation of percentage contents:<\/p>\n
\u2014 for each impurity, use the concentration of salbutamol in reference solution (a).<\/p>\n
Limits:<\/p>\n
\u2014 impurities C, O: for each impurity, maximum 0.3 per cent;<\/p>\n
\u2014 impurity P: maximum 0.2 per cent;<\/p>\n
\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n
\u2014 total: maximum 1.0 per cent;<\/p>\n
\u2014 reporting threshold: 0.05 per cent.<\/p>\n
Boron<\/h3>\n
Maximum 50 ppm.<\/p>\n
Test solution: To 50 mg of the substance to be examined add 5 mL of a solution containing 13 g\/L of anhydrous sodium carbonate R and 17 g\/L of potassium carbonate R. Evaporate to dryness on a water-bath and dry at 120 \u00b0C. Ignite the residue rapidly until the organic matter has been destroyed, allow to cool and add 0.5 mL of water R and 3.0 mL of a
\nfreshly prepared 1.25 g\/L solution of curcumin R in glacial acetic acid R. Warm gently to effect solution, allow to cool and add 3.0 mL of a mixture prepared by adding 5 mL of sulfuric acid R, slowly and with stirring, to 5 mL of glacial acetic acid R. Mix and allow to stand for 30 min. Dilute to 100.0 mL with ethanol (96 per cent) R, filter and use the filtrate.<\/p>\n
Reference solution: Dissolve 0.572 g of boric acid R in 1000.0 mL of water R. Dilute 1.0 mL of the solution to 100.0 mL with water R. To 2.5 mL of this solution add 5 mL of a solution containing 13 g\/L of anhydrous sodium carbonate R and 17 g\/L of potassium carbonate R, and treat this mixture in the same manner as the test solution.<\/p>\n
Measure the absorbance (2.2.25) of the test solution and of the reference solution at the absorption maximum at about 555 nm. The absorbance of the test solution is not greater than that of the reference solution.<\/p>\n
Loss on drying (2.2.32)<\/h4>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n
Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Dissolve 0.200 g in 30 mL of anhydrous acetic acid 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 23.93 mg of C_{13<\/sub>H_{21<\/sub>NO_{3<\/sub>.<\/p>\n}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities C, O, P.<\/p>\n
Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) A, B, D, E, F, G, H, I, J, K, L, M, N, Q.<\/p>\n
$\"Salbutamol$ <\/p>\n
A. 4-[(1RS)-2-(tert-butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
B. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
C. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-methylphenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
D. 5-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-hydroxybenzaldehyde,<\/p>\n
$\"Salbutamol$ <\/p>\n
E. 4-[(1RS)-2-[benzyl(tert-butyl)amino]-1-hydroxyethyl]-2-(hydroxymethyl)phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
F. 2,2\u2032-[oxybis(methylene)]bis[4-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]phenol],<\/p>\n
$\"Salbutamol$ <\/p>\n
G. 2-[benzyl(tert-butyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethan-1-one,<\/p>\n
$\"Salbutamol$ <\/p>\n
H. 4-[2-(tert-butylamino)ethyl]-2-methylphenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
I. (1RS)-1-[4-(benzyloxy)-3-(hydroxymethyl)phenyl]-2-(tert-butylamino)ethan-1-ol,<\/p>\n
$\"Salbutamol$ <\/p>\n
J. 2-(tert-butylamino)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethan-1-one (salbutamone),<\/p>\n
$\"Salbutamol$ <\/p>\n
K. 2-(tert-butylamino)-1-[3-chloro-4-hydroxy-5-(hydroxymethyl)phenyl]ethan-1-one,<\/p>\n
$\"Salbutamol$ <\/p>\n
L. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-chloro-6-(hydroxymethyl)phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
M. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-(methoxymethyl)phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
N. 4-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]-2-[[5-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]-2-hydroxyphenyl]methyl]-6-(hydroxymethyl)phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
O. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-(ethoxymethyl)phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
P. 4-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]-2-[[(2\u039e)-2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethoxy]methyl]phenol,<\/p>\n
$\"Salbutamol$ <\/p>\n
Q. 4-hydroxy-3-(hydroxymethyl)benzaldehyde.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 0529) C13H21NO3\u00a0 \u00a0 \u00a0 \u00a0239.3\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 18559-94-9 Action and use Beta2-adrenoceptor agonist; bronchodilator. Preparation Salbutamol Pressurised Inhalation DEFINITION 4-[(1RS)-2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol. Content 98.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, soluble in ethanol (96 per cent), very…<\/p>\n","protected":false},"author":2,"featured_media":29111,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29068","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\/29068","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=29068"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29068\/revisions"}],"predecessor-version":[{"id":29113,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29068\/revisions\/29113"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29111"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29068"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29068"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29068"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time<\/strong> \n(min)<\/strong><\/td>\n	Mobile phase A<\/strong> \n(per cent V\/V)<\/strong><\/td>\n	Mobile phase B<\/strong> \n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 5<\/td>\n	95<\/td>\n	5<\/td>\n<\/tr>\n
5 – 25<\/td>\n	95 \u2192 70<\/td>\n	5 \u2192 30<\/td>\n<\/tr>\n
25 – 27<\/td>\n	70<\/td>\n	30<\/td>\n<\/tr>\n
27 – 30<\/td>\n	70 \u2192 10<\/td>\n	30 \u2192 90<\/td>\n<\/tr>\n
30 – 35<\/td>\n	10<\/td>\n	90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 1.0 mL\/min.<\/p>\n Detection: Spectrophotometer at 273 nm.<\/p>\n Injection: 20 \u03bcL.<\/p>\n Identification of impurities: Use the chromatogram supplied with salbutamol for peak identification CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities C, F, N, O and P; use the chromatogram obtained with reference solution (c) to identify the peak due to impurity J.<\/p>\n Relative retention: With reference to salbutamol (retention time = about 5 min): impurity J = about 0.92; impurity C = about 2.3; impurity N (isomer 1) = about 2.84; impurity N (isomer 2) = about 2.86; impurity P = about 2.91; impurity F = about 3.03; impurity O = about 3.07.<\/p>\n System suitability:<\/p>\n \u2014 resolution: minimum 1.5 between the peaks due to impurities F and O in the chromatogram obtained with reference solution (b);<\/p>\n \u2014 peak-to-valley ratio: minimum 2.0, where H_{p<\/sub> = height above the baseline of the peak due to impurity J and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to salbutamol in the chromatogram obtained with reference solution (c); minimum 2.0, where H_{p<\/sub> = height above the baseline of the peak due to impurity N (isomer 1) and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity N (isomer 2) in the chromatogram obtained with reference solution (b); minimum 2.0, where H_{p <\/sub>= height above the baseline of the peak due to impurity N (isomer 2) and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity P in the chromatogram \nobtained with reference solution (b).<\/p>\n}}}}}} Calculation of percentage contents:<\/p>\n \u2014 for each impurity, use the concentration of salbutamol in reference solution (a).<\/p>\n Limits:<\/p>\n \u2014 impurities C, O: for each impurity, maximum 0.3 per cent;<\/p>\n \u2014 impurity P: maximum 0.2 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 1.0 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Boron<\/h3>\n Maximum 50 ppm.<\/p>\n Test solution: To 50 mg of the substance to be examined add 5 mL of a solution containing 13 g\/L of anhydrous sodium carbonate R and 17 g\/L of potassium carbonate R. Evaporate to dryness on a water-bath and dry at 120 \u00b0C. Ignite the residue rapidly until the organic matter has been destroyed, allow to cool and add 0.5 mL of water R and 3.0 mL of a \nfreshly prepared 1.25 g\/L solution of curcumin R in glacial acetic acid R. Warm gently to effect solution, allow to cool and add 3.0 mL of a mixture prepared by adding 5 mL of sulfuric acid R, slowly and with stirring, to 5 mL of glacial acetic acid R. Mix and allow to stand for 30 min. Dilute to 100.0 mL with ethanol (96 per cent) R, filter and use the filtrate.<\/p>\n Reference solution: Dissolve 0.572 g of boric acid R in 1000.0 mL of water R. Dilute 1.0 mL of the solution to 100.0 mL with water R. To 2.5 mL of this solution add 5 mL of a solution containing 13 g\/L of anhydrous sodium carbonate R and 17 g\/L of potassium carbonate R, and treat this mixture in the same manner as the test solution.<\/p>\n Measure the absorbance (2.2.25) of the test solution and of the reference solution at the absorption maximum at about 555 nm. The absorbance of the test solution is not greater than that of the reference solution.<\/p>\n Loss on drying (2.2.32)<\/h4>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n Sulfated ash (2.4.14)<\/h4>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n ASSAY<\/h2>\n Dissolve 0.200 g in 30 mL of anhydrous acetic acid 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 23.93 mg of C_{13<\/sub>H_{21<\/sub>NO_{3<\/sub>.<\/p>\n}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\n Specified impurities C, O, P.<\/p>\n Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) A, B, D, E, F, G, H, I, J, K, L, M, N, Q.<\/p>\n $\"Salbutamol$ <\/p>\n A. 4-[(1RS)-2-(tert-butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol,<\/p>\n $\"Salbutamol$ <\/p>\n B. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]phenol,<\/p>\n $\"Salbutamol$ <\/p>\n C. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-methylphenol,<\/p>\n $\"Salbutamol$ <\/p>\n D. 5-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-hydroxybenzaldehyde,<\/p>\n $\"Salbutamol$ <\/p>\n E. 4-[(1RS)-2-[benzyl(tert-butyl)amino]-1-hydroxyethyl]-2-(hydroxymethyl)phenol,<\/p>\n $\"Salbutamol$ <\/p>\n F. 2,2\u2032-[oxybis(methylene)]bis[4-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]phenol],<\/p>\n $\"Salbutamol$ <\/p>\n G. 2-[benzyl(tert-butyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethan-1-one,<\/p>\n $\"Salbutamol$ <\/p>\n H. 4-[2-(tert-butylamino)ethyl]-2-methylphenol,<\/p>\n $\"Salbutamol$ <\/p>\n I. (1RS)-1-[4-(benzyloxy)-3-(hydroxymethyl)phenyl]-2-(tert-butylamino)ethan-1-ol,<\/p>\n $\"Salbutamol$ <\/p>\n J. 2-(tert-butylamino)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethan-1-one (salbutamone),<\/p>\n $\"Salbutamol$ <\/p>\n K. 2-(tert-butylamino)-1-[3-chloro-4-hydroxy-5-(hydroxymethyl)phenyl]ethan-1-one,<\/p>\n $\"Salbutamol$ <\/p>\n L. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-chloro-6-(hydroxymethyl)phenol,<\/p>\n $\"Salbutamol$ <\/p>\n M. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-(methoxymethyl)phenol,<\/p>\n $\"Salbutamol$ <\/p>\n N. 4-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]-2-[[5-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]-2-hydroxyphenyl]methyl]-6-(hydroxymethyl)phenol,<\/p>\n $\"Salbutamol$ <\/p>\n O. 4-[(1RS)-2-(tert-butylamino)-1-hydroxyethyl]-2-(ethoxymethyl)phenol,<\/p>\n $\"Salbutamol$ <\/p>\n P. 4-[(1\u039e)-2-(tert-butylamino)-1-hydroxyethyl]-2-[[(2\u039e)-2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethoxy]methyl]phenol,<\/p>\n $\"Salbutamol$ <\/p>\n Q. 4-hydroxy-3-(hydroxymethyl)benzaldehyde.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 0529) C13H21NO3\u00a0 \u00a0 \u00a0 \u00a0239.3\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 18559-94-9 Action and use Beta2-adrenoceptor agonist; bronchodilator. Preparation Salbutamol Pressurised Inhalation DEFINITION 4-[(1RS)-2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol. Content 98.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, soluble in ethanol (96 per cent), very…<\/p>\n","protected":false},"author":2,"featured_media":29111,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29068","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\/29068","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=29068"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29068\/revisions"}],"predecessor-version":[{"id":29113,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29068\/revisions\/29113"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29111"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29068"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29068"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29068"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n98.0 per cent to 101.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nWhite or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\nSparingly soluble in water, soluble in ethanol (96 per cent), very slightly soluble or practically insoluble in methylene chloride.<\/p>\n

mp<\/h3>\nAbout 155 \u00b0C, with decomposition.<\/p>\n

IDENTIFICATION<\/h2>\nInfrared absorption spectrophotometry (2.2.24).<\/p>\nComparison: salbutamol CRS.<\/p>\n

TESTS<\/h2>\n

Appearance of solution<\/h3>\nThe solution is clear (2.2.1) and not more intensely coloured than reference solution BY5<\/sub> (2.2.2, Method II).\\<\/p>\nDissolve 0.5 g in methanol R and dilute to 25 mL with the same solvent.<\/p>\n

Loss on drying (2.2.32)<\/h4>\nMaximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\nMaximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\nDissolve 0.200 g in 30 mL of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n1 mL of 0.1 M perchloric acid is equivalent to 23.93 mg of C13<\/sub>H21<\/sub>NO3<\/sub>.<\/p>\n

STORAGE<\/h2>\nProtected from light.<\/p>\n

Content<\/h3>\n
98.0 per cent to 101.0 per cent (dried substance).<\/p>\n

Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\n
Sparingly soluble in water, soluble in ethanol (96 per cent), very slightly soluble or practically insoluble in methylene chloride.<\/p>\n

mp<\/h3>\n
About 155 \u00b0C, with decomposition.<\/p>\n

IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: salbutamol CRS.<\/p>\n

Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution BY_{5<\/sub> (2.2.2, Method II).\\<\/p>\n}
Dissolve 0.5 g in methanol R and dilute to 25 mL with the same solvent.<\/p>\n

Loss on drying (2.2.32)<\/h4>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n
Dissolve 0.200 g in 30 mL of anhydrous acetic acid 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 23.93 mg of C_{13<\/sub>H_{21<\/sub>NO_{3<\/sub>.<\/p>\n}}}

STORAGE<\/h2>\n
Protected from light.<\/p>\n