{"id":26726,"date":"2025-11-06T09:53:53","date_gmt":"2025-11-06T02:53:53","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26726"},"modified":"2025-11-06T09:53:53","modified_gmt":"2025-11-06T02:53:53","slug":"perphenazine","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/perphenazine\/","title":{"rendered":"Perphenazine"},"content":{"rendered":"

(Ph. Eur. monograph 0629)<\/em><\/p>\n

C_{21<\/sub>H_{26<\/sub>ClN_{3<\/sub>OS 404.0 58-39-9<\/p>\n}}}

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

Dopamine receptor antagonist; neuroleptic.<\/p>\n

DEFINITION<\/h2>\n
2-[4-[3-(2-Chloro-10H-phenothiazin-10-yl)propyl]piperazin-1-yl]ethanol.<\/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 yellowish-white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). It dissolves in dilute solutions of hydrochloric acid.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Melting point (2.2.14): 96 \u00b0C to 100 \u00b0C.<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: perphenazine CRS.<\/p>\n
TESTS<\/h2>\n
Appearance of solution<\/h3>\n
The solution is clear (2.2.1).<\/p>\n
Dissolve 0.20 g in 10 mL of methanol R.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29). Prepare the solutions immediately before use. Carry out the test protected from light.<\/p>\n
Test solution: Dissolve 20 mg of the substance to be examined in mobile phase A and dilute to 10.0 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 perphenazine for system suitability CRS (containing impurities A and B) in 1.0 mL of mobile phase A.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: spherical base-deactivated octylsilyl silica gel for chromatography R (4 \u03bcm);<\/p>\n
\u2014 temperature: 30 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: mix 35 volumes of acetonitrile R and 65 volumes of a 7 g\/L solution of sodium dihydrogen phosphate R;<\/p>\n
\u2014 mobile phase B: acetonitrile R;<\/p>\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 100<\/td>\n 0<\/td>\n<\/tr>\n
5 – 10<\/td>\n 100 \u2192 80<\/td>\n 0 \u2192 20<\/td>\n<\/tr>\n
10 – 33<\/td>\n 80 \u2192 30<\/td>\n 20 \u2192 70<\/td>\n<\/tr>\n
33 – 48<\/td>\n 30 \u2192 100<\/td>\n 70 \u2192 0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.3 mL\/min.<\/p>\n
Detection: Spectrophotometer at 245 nm.<\/p>\n
Injection: 10 \u03bcL.<\/p>\n
Identification of impurities: Use the chromatogram supplied with perphenazine for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and B.<\/p>\n
Relative retention: With reference to perphenazine (retention time = about 12 min): impurity A = about 0.3; impurity B = about 0.8.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 resolution: minimum 4.0 between the peaks due to impurity B and perphenazine.<\/p>\n
Limits:<\/p>\n
\u2014 correction factor: for the calculation of content, multiply the peak area of impurity A by 0.6;<\/p>\n
\u2014 impurity A: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent);<\/p>\n
\u2014 impurity B: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent);<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n
\u2014 total: not more than 10 times the area of the principal peak in the chromatogram obtained with reference solution (a) (1.0 per cent);<\/p>\n
\u2014 disregard limit: 0.5 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 0.5 per cent, determined on 1.000 g by drying in vacuo at 65 \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
Dissolve 0.150 g in 25 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 20.20 mg of C_{21<\/sub>H_{26<\/sub>ClN_{3<\/sub>OS.<\/p>\n}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities A, B.<\/p>\n
$\"Perphenazine$ <\/p>\n
A. 2-[4-[3-(2-chloro-5-oxido-10H-phenothiazin-10-yl)propyl]piperazin-1-yl]ethanol,<\/p>\n
$\"Perphenazine$ <\/p>\n
B. 2-[4-[3-(10H-phenothiazin-10-yl)propyl]piperazin-1-yl]ethanol.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 0629) C21H26ClN3OS 404.0 58-39-9 Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION 2-[4-[3-(2-Chloro-10H-phenothiazin-10-yl)propyl]piperazin-1-yl]ethanol. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or yellowish-white, crystalline powder. Solubility Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). It dissolves in dilute solutions of…<\/p>\n","protected":false},"author":4,"featured_media":26753,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26726","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\/26726","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=26726"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26726\/revisions"}],"predecessor-version":[{"id":26758,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26726\/revisions\/26758"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26753"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26726"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26726"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26726"}],"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	100<\/td>\n	0<\/td>\n<\/tr>\n
5 – 10<\/td>\n	100 \u2192 80<\/td>\n	0 \u2192 20<\/td>\n<\/tr>\n
10 – 33<\/td>\n	80 \u2192 30<\/td>\n	20 \u2192 70<\/td>\n<\/tr>\n
33 – 48<\/td>\n	30 \u2192 100<\/td>\n	70 \u2192 0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 1.3 mL\/min.<\/p>\n Detection: Spectrophotometer at 245 nm.<\/p>\n Injection: 10 \u03bcL.<\/p>\n Identification of impurities: Use the chromatogram supplied with perphenazine for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and B.<\/p>\n Relative retention: With reference to perphenazine (retention time = about 12 min): impurity A = about 0.3; impurity B = about 0.8.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 4.0 between the peaks due to impurity B and perphenazine.<\/p>\n Limits:<\/p>\n \u2014 correction factor: for the calculation of content, multiply the peak area of impurity A by 0.6;<\/p>\n \u2014 impurity A: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent);<\/p>\n \u2014 impurity B: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n \u2014 total: not more than 10 times the area of the principal peak in the chromatogram obtained with reference solution (a) (1.0 per cent);<\/p>\n \u2014 disregard limit: 0.5 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 0.5 per cent, determined on 1.000 g by drying in vacuo at 65 \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 Dissolve 0.150 g in 25 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 20.20 mg of C_{21<\/sub>H_{26<\/sub>ClN_{3<\/sub>OS.<\/p>\n}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\n Specified impurities A, B.<\/p>\n $\"Perphenazine$ <\/p>\n A. 2-[4-[3-(2-chloro-5-oxido-10H-phenothiazin-10-yl)propyl]piperazin-1-yl]ethanol,<\/p>\n $\"Perphenazine$ <\/p>\n B. 2-[4-[3-(10H-phenothiazin-10-yl)propyl]piperazin-1-yl]ethanol.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 0629) C21H26ClN3OS 404.0 58-39-9 Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION 2-[4-[3-(2-Chloro-10H-phenothiazin-10-yl)propyl]piperazin-1-yl]ethanol. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or yellowish-white, crystalline powder. Solubility Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). It dissolves in dilute solutions of…<\/p>\n","protected":false},"author":4,"featured_media":26753,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26726","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\/26726","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=26726"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26726\/revisions"}],"predecessor-version":[{"id":26758,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26726\/revisions\/26758"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26753"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26726"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26726"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26726"}],"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 yellowish-white, crystalline powder.<\/p>\n

Solubility<\/h3>\nPractically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). It dissolves in dilute solutions of hydrochloric acid.<\/p>\n

IDENTIFICATION<\/h2>\nA. Melting point (2.2.14): 96 \u00b0C to 100 \u00b0C.<\/p>\nB. Infrared absorption spectrophotometry (2.2.24).<\/p>\nComparison: perphenazine CRS.<\/p>\n

TESTS<\/h2>\n

Appearance of solution<\/h3>\nThe solution is clear (2.2.1).<\/p>\nDissolve 0.20 g in 10 mL of methanol R.<\/p>\n

Loss on drying (2.2.32)<\/h3>\nMaximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 65 \u00b0C for 4 h.<\/p>\n

Sulfated ash (2.4.14)<\/h3>\nMaximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\nDissolve 0.150 g in 25 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 20.20 mg of C21<\/sub>H26<\/sub>ClN3<\/sub>OS.<\/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 yellowish-white, crystalline powder.<\/p>\n

Solubility<\/h3>\n
Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). It dissolves in dilute solutions of hydrochloric acid.<\/p>\n

IDENTIFICATION<\/h2>\n
A. Melting point (2.2.14): 96 \u00b0C to 100 \u00b0C.<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: perphenazine CRS.<\/p>\n

Appearance of solution<\/h3>\n
The solution is clear (2.2.1).<\/p>\n
Dissolve 0.20 g in 10 mL of methanol R.<\/p>\n

Loss on drying (2.2.32)<\/h3>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 65 \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
Dissolve 0.150 g in 25 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 20.20 mg of C_{21<\/sub>H_{26<\/sub>ClN_{3<\/sub>OS.<\/p>\n}}}

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