{"id":11900,"date":"2025-10-10T10:40:46","date_gmt":"2025-10-10T03:40:46","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=11900"},"modified":"2025-10-10T10:40:46","modified_gmt":"2025-10-10T03:40:46","slug":"desipramine-hydrochloride","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/desipramine-hydrochloride\/","title":{"rendered":"Desipramine Hydrochloride"},"content":{"rendered":"

(Ph. Eur. monograph 0481)<\/p>\n

C_{18<\/sub>H_{23<\/sub>ClN_{2<\/sub>\u00a0 \u00a0302.8\u00a0 \u00a058-28-6<\/p>\n}}}

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

Monoamine reuptake inhibitor; tricyclic antidepressant.<\/p>\n

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

Desipramine Tablets<\/p>\n

DEFINITION<\/h2>\n
3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1-amine hydrochloride.<\/p>\n
Content<\/h3>\n
99.0 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 and in anhydrous ethanol, practically insoluble in heptane.<\/p>\n
mp<\/h3>\n
About 214 \u00b0C.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: desipramine hydrochloride CRS.<\/p>\n
B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Dissolve 1.25 g in carbon dioxide-free water R, warming to not more than 30 \u00b0C if necessary, and dilute to 25 mL with the same solvent.<\/p>\n
Appearance of solution<\/h3>\n
Solution S, examined immediately after preparation, is not more intensely coloured than reference solution BY6 (2.2.2, Method II).<\/p>\n
Acidity or alkalinity<\/h3>\n
To 10 mL of solution S add 0.1 mL of methyl red solution R and 0.3 mL of 0.01 M sodium hydroxide. The solution is yellow.<\/p>\n
Not more than 0.5 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator to red.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Buffer solution: Dissolve 5.2 g of dipotassium hydrogen phosphate R in 1000 mL of water for chromatography R, add<\/p>\n
1 mL of triethylamine R and adjust to pH 6.4 with phosphoric acid R.<\/p>\n
Test solution: Dissolve 50.0 mg of the substance to be examined in mobile phase A and dilute to 100.0 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 5 mg of imipramine hydrochloride R (impurity A) in mobile phase A and dilute to 100 mL with mobile phase A. Mix 1 mL of the solution and 9 mL of the test solution, and dilute to 100 ml with mobile phase A.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n
\u2014 temperature: 60 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: methanol R, acetonitrile R, buffer solution (11:14:75 V\/V\/V);<\/p>\n
\u2014 mobile phase B: methanol R, acetonitrile R, buffer solution (28:34:38 V\/V\/V);<\/p>\n\n\n\n\n\n\n
Time<\/strong><\/p>\n
(min)<\/strong><\/td>\n
Mobile phase A<\/strong><\/p>\n
(per cent V\/V)<\/strong><\/td>\n
Mobile phase B<\/strong><\/p>\n
(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 2<\/td>\n 85<\/td>\n 15<\/td>\n<\/tr>\n
2 – 37<\/td>\n \u00a085 \u2192 0<\/td>\n 15 \u2192 100<\/td>\n<\/tr>\n
37 – 52<\/td>\n 0<\/td>\n 100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.4 mL\/min.<\/p>\n
Detection: Spectrophotometer at 254 nm.<\/p>\n
Injection: 40 \u03bcL.<\/p>\n
Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity A.<\/p>\n
Relative retention: With reference to desipramine (retention time = about 19 min): impurity A = about 1.7.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 resolution: minimum 25 between the peaks due to desipramine and impurity A.<\/p>\n
Calculation of percentage contents:<\/p>\n
\u2014 for each impurity, use the concentration of desipramine hydrochloride in reference solution (a).<\/p>\n
Limits:<\/p>\n
\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n
\u2014 total: maximum 0.5 per cent;<\/p>\n
\u2014 reporting threshold: 0.05 per cent.<\/p>\n
Loss on drying (2.2.32)<\/h3>\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)<\/h3>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Dissolve 0.250 g in a mixture of 5 mL of 0.01 M hydrochloric acid and 50 mL of ethanol (96 per cent) R. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.<\/p>\n
1 mL of 0.1 M sodium hydroxide is equivalent to 30.28 mg of C_{18<\/sub>H_{23<\/sub>ClN_{2<\/sub>.<\/p>\n}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\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.<\/p>\n
$\"Desipramine$ <\/p>\n
A. 3-(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine (imipramine).<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 0481) C18H23ClN2\u00a0 \u00a0302.8\u00a0 \u00a058-28-6 Action and use Monoamine reuptake inhibitor; tricyclic antidepressant. Preparation Desipramine Tablets DEFINITION 3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1-amine hydrochloride. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water and in anhydrous ethanol, practically insoluble in heptane. mp About 214…<\/p>\n","protected":false},"author":4,"featured_media":11916,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-11900","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\/11900","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=11900"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/11900\/revisions"}],"predecessor-version":[{"id":11920,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/11900\/revisions\/11920"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/11916"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=11900"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=11900"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=11900"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time<\/strong><\/p>\n (min)<\/strong><\/td>\n	Mobile phase A<\/strong><\/p>\n (per cent V\/V)<\/strong><\/td>\n	Mobile phase B<\/strong><\/p>\n (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 2<\/td>\n	85<\/td>\n	15<\/td>\n<\/tr>\n
2 – 37<\/td>\n	\u00a085 \u2192 0<\/td>\n	15 \u2192 100<\/td>\n<\/tr>\n
37 – 52<\/td>\n	0<\/td>\n	100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 1.4 mL\/min.<\/p>\n Detection: Spectrophotometer at 254 nm.<\/p>\n Injection: 40 \u03bcL.<\/p>\n Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity A.<\/p>\n Relative retention: With reference to desipramine (retention time = about 19 min): impurity A = about 1.7.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 25 between the peaks due to desipramine and impurity A.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 for each impurity, use the concentration of desipramine hydrochloride in reference solution (a).<\/p>\n Limits:<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.5 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Loss on drying (2.2.32)<\/h3>\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)<\/h3>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n ASSAY<\/h2>\n Dissolve 0.250 g in a mixture of 5 mL of 0.01 M hydrochloric acid and 50 mL of ethanol (96 per cent) R. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 30.28 mg of C_{18<\/sub>H_{23<\/sub>ClN_{2<\/sub>.<\/p>\n}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\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.<\/p>\n $\"Desipramine$ <\/p>\n A. 3-(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine (imipramine).<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 0481) C18H23ClN2\u00a0 \u00a0302.8\u00a0 \u00a058-28-6 Action and use Monoamine reuptake inhibitor; tricyclic antidepressant. Preparation Desipramine Tablets DEFINITION 3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1-amine hydrochloride. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water and in anhydrous ethanol, practically insoluble in heptane. mp About 214…<\/p>\n","protected":false},"author":4,"featured_media":11916,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-11900","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\/11900","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=11900"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/11900\/revisions"}],"predecessor-version":[{"id":11920,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/11900\/revisions\/11920"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/11916"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=11900"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=11900"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=11900"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n99.0 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 and in anhydrous ethanol, practically insoluble in heptane.<\/p>\n

mp<\/h3>\nAbout 214 \u00b0C.<\/p>\n

IDENTIFICATION<\/h2>\nA. Infrared absorption spectrophotometry (2.2.24).<\/p>\nComparison: desipramine hydrochloride CRS.<\/p>\nB. It gives reaction (a) of chlorides (2.3.1).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\nDissolve 1.25 g in carbon dioxide-free water R, warming to not more than 30 \u00b0C if necessary, and dilute to 25 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\nSolution S, examined immediately after preparation, is not more intensely coloured than reference solution BY6 (2.2.2, Method II).<\/p>\n

Acidity or alkalinity<\/h3>\nTo 10 mL of solution S add 0.1 mL of methyl red solution R and 0.3 mL of 0.01 M sodium hydroxide. The solution is yellow.<\/p>\nNot more than 0.5 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator to red.<\/p>\n

Loss on drying (2.2.32)<\/h3>\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)<\/h3>\nMaximum 0.1 per cent, determined on 1.0 g.<\/p>\n

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

Content<\/h3>\n
99.0 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 and in anhydrous ethanol, practically insoluble in heptane.<\/p>\n

mp<\/h3>\n
About 214 \u00b0C.<\/p>\n

IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: desipramine hydrochloride CRS.<\/p>\n
B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n

Solution S<\/h3>\n
Dissolve 1.25 g in carbon dioxide-free water R, warming to not more than 30 \u00b0C if necessary, and dilute to 25 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n
Solution S, examined immediately after preparation, is not more intensely coloured than reference solution BY6 (2.2.2, Method II).<\/p>\n

Acidity or alkalinity<\/h3>\n
To 10 mL of solution S add 0.1 mL of methyl red solution R and 0.3 mL of 0.01 M sodium hydroxide. The solution is yellow.<\/p>\n
Not more than 0.5 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator to red.<\/p>\n

Loss on drying (2.2.32)<\/h3>\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)<\/h3>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

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