{"id":31399,"date":"2025-11-13T15:20:51","date_gmt":"2025-11-13T08:20:51","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=31399"},"modified":"2025-11-13T15:20:51","modified_gmt":"2025-11-13T08:20:51","slug":"vindesine-sulfate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/vindesine-sulfate\/","title":{"rendered":"Vindesine Sulfate"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

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

Vinca alkaloid cytotoxic.<\/p>\n

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

Vindesine Injection<\/p>\n

DEFINITION<\/h2>\n
3-(Carbamoyl)-O4-deacetyl-3-de(methoxycarbonyl)vincaleukoblastine sulfate.<\/p>\n
Content<\/strong><\/p>\n
96.0 per cent to 103.0 per cent (anhydrous substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, amorphous, hygroscopic substance.<\/p>\n
Solubility<\/h3>\n
Freely soluble in water and in methanol, practically insoluble in cyclohexane.<\/p>\n
IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison\u00a0 Ph. Eur. reference spectrum of vindesine sulfate.<\/p>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Dissolve 50 mg in carbon dioxide-free water R and dilute to 10 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 Y7 (2.2.2, Method I).<\/p>\n
pH (2.2.3)<\/strong><\/p>\n
3.5 to 5.5 for solution S.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29). Keep the solutions in iced water before use.<\/p>\n
Test solution\u00a0 Dissolve 10.0 mg of the substance to be examined in water R and dilute to 10.0 mL with the same solvent.<\/p>\n
Reference solution (a) Dilute 1.0 mL of the test solution to 50.0 mL with water R. Dilute 1.0 mL of this solution to 10.0 mL with water R.<\/p>\n
Reference solution (b) Dissolve 1.0 mg of desacetylvinblastine CRS in water R, add 1.0 mL of the test solution and dilute to 50.0 mL with water R.<\/p>\n
Reference solution (c) In order to prepare impurity A in situ, dissolve 0.2 g of the substance to be examined in dilute hydrogen peroxide solution R and dilute to 20.0 mL with the same solvent. Dilute 2.0 mL of the solution to 10.0 mL with water R. Inject the solution within 1 h of preparation.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: 1.5 per cent V\/V solution of diethylamine R adjusted to pH 7.4 with phosphoric acid R;<\/p>\n
\u2014 mobile phase B: methanol R;<\/p>\n\n\n\n\n\n\n
Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 40<\/td>\n 49<\/td>\n 51<\/td>\n<\/tr>\n
40 – 49<\/td>\n 49 \u2192 30<\/td>\n 51 \u2192 70<\/td>\n<\/tr>\n
49 – 60<\/td>\n 30<\/td>\n 70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate\u00a0 2 mL\/min.<\/p>\n
Detection\u00a0 Spectrophotometer at 270 nm.<\/p>\n
Injection\u00a0 200 \u00b5L.<\/p>\n
Identification of impurities Use the chromatogram obtained with reference solution (c) to identify the peak due to impurity A.<\/p>\n
Relative retention\u00a0 With reference to vindesine (retention time = about 25 min): impurity A = about 0.2.<\/p>\n
System suitability\u00a0 Reference solution (b):<\/p>\n
\u2014 the retention time of vindesine is less than 40 min;<\/p>\n
\u2014 resolution: minimum 2.0 between the peaks due to vindesine and desacetylvinblastine;<\/p>\n
\u2014 symmetry factor: maximum 2.0 for the peak due to vindesine.<\/p>\n
Limits:<\/p>\n
\u2014 impurity A: not more than 2.5 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 0.5 times 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 4 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.8 per cent);<\/p>\n
\u2014 disregard limit: 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n
Water (2.5.32)<\/strong><\/p>\n
Maximum 5.0 per cent, determined on 50.0 mg using the evaporation technique at 150 \u00b0C; weigh the sample in an inert atmosphere and carry out a blank test.<\/p>\n
ASSAY<\/h2>\n
Liquid chromatography (2.2.29). Keep the solutions in iced water before use.<\/p>\n
Test solution\u00a0 Dissolve 5.0 mg of the substance to be examined in water R and dilute to 10.0 mL with the same solvent.<\/p>\n
Reference solution (a) Dissolve and dilute the entire contents of a vial of vindesine sulfate CRS with water R to yield a concentration of approximately 0.50 mg\/mL.<\/p>\n
Reference solution (b)\u00a0 Add 1.0 mg of desacetylvinblastine CRS to 2.0 mL of reference solution (a).<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n
Mobile phase\u00a0 Mix 38 volumes of a 1.5 per cent V\/V solution of diethylamine R, previously adjusted to pH 7.4 with phosphoric acid R, and 62 volumes of methanol R.<\/p>\n
Flow rate 1 mL\/min.<\/p>\n
Detection\u00a0 Spectrophotometer at 270 nm.<\/p>\n
Injection\u00a0 20 \u00b5L.<\/p>\n
System suitability\u00a0 Reference solution (b):<\/p>\n
\u2014 resolution: minimum 1.5 between the peaks due to vindesine and desacetylvinblastine;<\/p>\n
\u2014 symmetry factor: maximum 2.0 for the peak due to vindesine;<\/p>\n
\u2014 repeatability: maximum relative standard deviation of 1.5 per cent for the peak due to vindesine after 5 injections.<\/p>\n
Calculate the percentage content of C_{43<\/sub>H_{57<\/sub>N_{5<\/sub>O_{11<\/sub>S taking into account the assigned content of vindesine sulfate CRS.<\/p>\n}}}}
STORAGE<\/h2>\n
In an airtight, high-density polyethylene container with a high-density polyethylene cap, at a temperature of -50 \u00b0C or below. If the substance is sterile, store in a sterile, airtight, tamper-evident container.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities\u00a0 A.<\/em><\/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) B, C.<\/em><\/p>\n
A. 3-(carbamoyl)-O4-deacetyl-3-de(methoxycarbonyl)vincaleukoblastine N6\u2032-oxide (vindesine N3-oxide),<\/p>\n
B. vincaleukoblastine (vinblastine),<\/p>\n
C. O4-deacetyl-23-demethoxy-23-hydrazinylvincaleukoblastine (deacetylvinblastine hydrazide).<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Vinca alkaloid cytotoxic. Preparation Vindesine Injection DEFINITION 3-(Carbamoyl)-O4-deacetyl-3-de(methoxycarbonyl)vincaleukoblastine sulfate. Content 96.0 per cent to 103.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, amorphous, hygroscopic substance. Solubility Freely soluble in water and in methanol, practically insoluble in cyclohexane. IDENTIFICATION Infrared absorption spectrophotometry (2.2.24)….<\/p>\n","protected":false},"author":5,"featured_media":31400,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31399","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\/31399","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=31399"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31399\/revisions"}],"predecessor-version":[{"id":31403,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31399\/revisions\/31403"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31400"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31399"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31399"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31399"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (min)<\/strong><\/td>\n	Mobile phase A (per cent V\/V)<\/strong><\/td>\n	Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 40<\/td>\n	49<\/td>\n	51<\/td>\n<\/tr>\n
40 – 49<\/td>\n	49 \u2192 30<\/td>\n	51 \u2192 70<\/td>\n<\/tr>\n
49 – 60<\/td>\n	30<\/td>\n	70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate\u00a0 2 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 270 nm.<\/p>\n Injection\u00a0 200 \u00b5L.<\/p>\n Identification of impurities Use the chromatogram obtained with reference solution (c) to identify the peak due to impurity A.<\/p>\n Relative retention\u00a0 With reference to vindesine (retention time = about 25 min): impurity A = about 0.2.<\/p>\n System suitability\u00a0 Reference solution (b):<\/p>\n \u2014 the retention time of vindesine is less than 40 min;<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to vindesine and desacetylvinblastine;<\/p>\n \u2014 symmetry factor: maximum 2.0 for the peak due to vindesine.<\/p>\n Limits:<\/p>\n \u2014 impurity A: not more than 2.5 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 0.5 times 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 4 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.8 per cent);<\/p>\n \u2014 disregard limit: 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n Water (2.5.32)<\/strong><\/p>\n Maximum 5.0 per cent, determined on 50.0 mg using the evaporation technique at 150 \u00b0C; weigh the sample in an inert atmosphere and carry out a blank test.<\/p>\n ASSAY<\/h2>\n Liquid chromatography (2.2.29). Keep the solutions in iced water before use.<\/p>\n Test solution\u00a0 Dissolve 5.0 mg of the substance to be examined in water R and dilute to 10.0 mL with the same solvent.<\/p>\n Reference solution (a) Dissolve and dilute the entire contents of a vial of vindesine sulfate CRS with water R to yield a concentration of approximately 0.50 mg\/mL.<\/p>\n Reference solution (b)\u00a0 Add 1.0 mg of desacetylvinblastine CRS to 2.0 mL of reference solution (a).<\/p>\n Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n Mobile phase\u00a0 Mix 38 volumes of a 1.5 per cent V\/V solution of diethylamine R, previously adjusted to pH 7.4 with phosphoric acid R, and 62 volumes of methanol R.<\/p>\n Flow rate 1 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 270 nm.<\/p>\n Injection\u00a0 20 \u00b5L.<\/p>\n System suitability\u00a0 Reference solution (b):<\/p>\n \u2014 resolution: minimum 1.5 between the peaks due to vindesine and desacetylvinblastine;<\/p>\n \u2014 symmetry factor: maximum 2.0 for the peak due to vindesine;<\/p>\n \u2014 repeatability: maximum relative standard deviation of 1.5 per cent for the peak due to vindesine after 5 injections.<\/p>\n Calculate the percentage content of C_{43<\/sub>H_{57<\/sub>N_{5<\/sub>O_{11<\/sub>S taking into account the assigned content of vindesine sulfate CRS.<\/p>\n}}}} STORAGE<\/h2>\n In an airtight, high-density polyethylene container with a high-density polyethylene cap, at a temperature of -50 \u00b0C or below. If the substance is sterile, store in a sterile, airtight, tamper-evident container.<\/p>\n IMPURITIES<\/h2>\n Specified impurities\u00a0 A.<\/em><\/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) B, C.<\/em><\/p>\n A. 3-(carbamoyl)-O4-deacetyl-3-de(methoxycarbonyl)vincaleukoblastine N6\u2032-oxide (vindesine N3-oxide),<\/p>\n B. vincaleukoblastine (vinblastine),<\/p>\n C. O4-deacetyl-23-demethoxy-23-hydrazinylvincaleukoblastine (deacetylvinblastine hydrazide).<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Vinca alkaloid cytotoxic. Preparation Vindesine Injection DEFINITION 3-(Carbamoyl)-O4-deacetyl-3-de(methoxycarbonyl)vincaleukoblastine sulfate. Content 96.0 per cent to 103.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, amorphous, hygroscopic substance. Solubility Freely soluble in water and in methanol, practically insoluble in cyclohexane. IDENTIFICATION Infrared absorption spectrophotometry (2.2.24)….<\/p>\n","protected":false},"author":5,"featured_media":31400,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31399","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\/31399","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=31399"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31399\/revisions"}],"predecessor-version":[{"id":31403,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31399\/revisions\/31403"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31400"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31399"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31399"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31399"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Appearance<\/h3>\nWhite or almost white, amorphous, hygroscopic substance.<\/p>\n

Solubility<\/h3>\nFreely soluble in water and in methanol, practically insoluble in cyclohexane.<\/p>\n

IDENTIFICATION<\/h2>\nInfrared absorption spectrophotometry (2.2.24).<\/p>\nComparison\u00a0 Ph. Eur. reference spectrum of vindesine sulfate.<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\nDissolve 50 mg in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\nSolution S is clear (2.2.1) and not more intensely coloured than reference solution Y7 (2.2.2, Method I).<\/p>\npH (2.2.3)<\/strong><\/p>\n3.5 to 5.5 for solution S.<\/p>\n

STORAGE<\/h2>\nIn an airtight, high-density polyethylene container with a high-density polyethylene cap, at a temperature of -50 \u00b0C or below. If the substance is sterile, store in a sterile, airtight, tamper-evident container.<\/p>\n

Appearance<\/h3>\n
White or almost white, amorphous, hygroscopic substance.<\/p>\n

Solubility<\/h3>\n
Freely soluble in water and in methanol, practically insoluble in cyclohexane.<\/p>\n

IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison\u00a0 Ph. Eur. reference spectrum of vindesine sulfate.<\/p>\n

Solution S<\/h3>\n
Dissolve 50 mg in carbon dioxide-free water R and dilute to 10 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 Y7 (2.2.2, Method I).<\/p>\n
pH (2.2.3)<\/strong><\/p>\n
3.5 to 5.5 for solution S.<\/p>\n

STORAGE<\/h2>\n
In an airtight, high-density polyethylene container with a high-density polyethylene cap, at a temperature of -50 \u00b0C or below. If the substance is sterile, store in a sterile, airtight, tamper-evident container.<\/p>\n