Vinca alkaloid cytotoxic.<\/p>\n
Preparation <\/strong><\/p>\n Vincristine Injection<\/p>\n Methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-6-formyl-5-hydroxy-8- methoxy-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate sulfate.<\/p>\n Content<\/strong><\/p>\n 95.0 per cent to 104.0 per cent (dried substance).<\/p>\n White or slightly yellowish, crystalline powder, very hygroscopic.<\/p>\n Freely soluble in water, slightly soluble in ethanol (96 per cent).<\/p>\n Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 Ph. Eur. reference spectrum of vincristine sulfate.<\/p>\n Dissolve 50.0 mg in carbon dioxide-free water R and dilute to 10.0 mL with the same solvent. Keep the solution in iced water to carry out the test for related substances.<\/p>\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 4.5.<\/p>\n Dilute 2 mL of solution S to 10 mL with carbon dioxide-free water R.<\/p>\n Liquid chromatography (2.2.29). Keep the solutions in iced water before use. Test solution Dilute 1.0 mL of solution S to 5.0 mL with water R.<\/p>\n Reference solution (a) Dissolve the contents of a vial of vincristine sulfate CRS in 5.0 mL of water R to obtain a concentration of 1.0 mg\/mL.<\/p>\n Reference solution (b)\u00a0 Dissolve 1.0 mg of vinblastine sulfate CRS in 1.0 mL of reference solution (a).<\/p>\n Reference solution (c) Dilute 1.0 mL of the test solution to 50.0 mL with water R. Reference solution (d) Dilute 1.0 mL of reference solution (c) to 20.0 mL with water R.<\/p>\n Precolumn:<\/p>\n \u2014 stationary phase: octylsilyl silica gel for chromatography R. Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.6 mm,<\/p>\n \u2014 stationary phase: octylsilyl 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 7.5 with phosphoric acid R,<\/p>\n \u2014 mobile phase B: methanol R,<\/p>\n Flow rate\u00a0 2 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 297 nm.<\/p>\n Injection\u00a0 20 \u00b5L.<\/p>\n System suitability\u00a0 Reference solution (b):<\/p>\n \u2014 resolution: minimum 4 between the peaks due to vincristine and vinblastine.<\/p>\n Limits:<\/p>\n \u2014 any impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (2.0 per cent),<\/p>\n \u2014 total: not more than 2.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (5.0 per cent),<\/p>\n \u2014 disregard limit: area of the peak in the chromatogram obtained with reference solution (d) (0.1 per cent).<\/p>\n Maximum 12.0 per cent, determined on 3 mg by thermogravimetry (2.2.34). Heat the substance to be examined to 200 \u00b0C increasing the temperature by 5 \u00b0C\/min, under a current of nitrogen for chromatography R, at a flow rate of 40 mL\/min.<\/p>\n Liquid chromatography (2.2.29) as described in the test for related substances, with the following modifications.<\/p>\n Mobile phase\u00a0 Mix 30 volumes of a 1.5 per cent V\/V solution of diethylamine R adjusted to pH 7.5 with phosphoric acid R and 70 volumes of methanol R. Flow rate 1.0 mL\/min.<\/p>\n Calculate the percentage content of C46<\/sub>H58<\/sub>N4<\/sub>O14<\/sub>S using the chromatogram obtained with reference solution (a) and the declared content of vincristine sulfate CRS.<\/p>\n In an airtight, glass container, protected from light, at a temperature not exceeding -20 \u00b0C. If the substance is sterile, store in a sterile, airtight, tamper-evident glass container.<\/p>\n Specified impurities\u00a0 A, B, C, D, H.<\/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) E, F, G.<\/em><\/p>\n A. methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(5R,7S,9S)-5-ethyl-5,6-dihydroxy-9- (methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-6-formyl-5-hydroxy-8- methoxy-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate (3\u2032-hydroxy-VCR),<\/p>\n B. methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(5R,7S,9S)-5-ethyl-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-6-formyl-5-hydroxy-8- methoxy-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate (4\u2032-deoxyvincristine),<\/p>\n C. methyl (3aR,4R,5S,5aR,10bS,13aR)-4-(acetyloxy)-3a-ethyl-9-[(5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-5-hydroxy-8-methoxy- 3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate (N-desmethylvinblastine),<\/p>\n D. methyl (3aR,4R,5S,5aR,10bR,13aR)-3a-ethyl-9-[(5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10- octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-6-formyl-4,5-dihydroxy-8-methoxy-3a,4,5,5a,6,11,12,13a-\u00a0 octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate (deacetylvincristine),<\/p>\n E. methyl (3aR,4R,5S,5aR,10bR,13aR)-3a-ethyl-9-[(5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10- octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-4,5-dihydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate (deacetylvinblastine),<\/p>\n F. methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(1aS,11S,13S,13aR)-1a-ethyl-11- (methoxycarbonyl)-1a,4,5,10,11,12,13,13a-octahydro-2H-3,13-methano-oxireno[9,10]azacycloundecino[5,4-b]indol-11- yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate (leurosine),<\/p>\n G. methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(1aS,11S,13S,13aR)-1a-ethyl-11- (methoxycarbonyl)-1a,4,5,10,11,12,13,13a-octahydro-2H-3,13-methano-oxireno[9,10]azacycloundecino[5,4-b]indol-11- yl]-6-formyl-5-hydroxy-8-methoxy-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate (formylleurosine),<\/p>\n H. vinblastine.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Vinca alkaloid cytotoxic. Preparation Vincristine Injection DEFINITION Methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-6-formyl-5-hydroxy-8- methoxy-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate sulfate. Content 95.0 per cent to 104.0 per cent (dried substance). CHARACTERS Appearance White or slightly yellowish, crystalline powder, very hygroscopic. Solubility Freely soluble in water, slightly soluble in ethanol (96 per cent). IDENTIFICATION Infrared…<\/p>\n","protected":false},"author":5,"featured_media":31137,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31136","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\/31136","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=31136"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31136\/revisions"}],"predecessor-version":[{"id":31171,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31136\/revisions\/31171"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31137"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
Related substances<\/h3>\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 \n 0 – 12<\/td>\n 38<\/td>\n 62<\/td>\n<\/tr>\n \n 12 – 27<\/td>\n 38 \u2192 8<\/td>\n 62 \u2192 92<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Loss on drying<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Vincristine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Vincristine-Sulfate-British-Pharmacopoeia-2025-1.jpg\")
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<\/p>\n