{"id":22223,"date":"2025-10-29T17:01:33","date_gmt":"2025-10-29T10:01:33","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22223"},"modified":"2025-10-29T17:01:33","modified_gmt":"2025-10-29T10:01:33","slug":"vindesine-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/vindesine-injection\/","title":{"rendered":"Vindesine Injection"},"content":{"rendered":"<p>Vindesine Sulphate for Injection<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Vinca alkaloid cytotoxic.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Vindesine Injection is a sterile solution of Vindesine Sulfate in a suitable liquid. It is prepared by dissolving Vindesine Sulfate for Injection in the requisite volume of a suitable diluent in accordance with the manufacturer\u2019s instructions.<\/p>\n<p>The injection complies with the requirements stated under Parenteral Preparations.<\/p>\n<h2>STORAGE<\/h2>\n<p>Vindesine Injection should be used immediately after preparation but, in any case, within the period recommended by the manufacturer when prepared and stored strictly in accordance with the manufacturer\u2019s instructions.<\/p>\n<h2>VINDESINE SULFATE FOR INJECTION<\/h2>\n<h2>DEFINITION<\/h2>\n<p>Vindesine Sulfate for Injection is a sterile material consisting of a mixture of one part by weight of Vindesine Sulfate and five parts by weight of a suitable carrier with or without other excipients. It is supplied in a sealed container.<\/p>\n<p>The contents of the sealed container comply with the requirements for Powders for Injections or Infusions stated under Parenteral Preparations and with the following requirements.<\/p>\n<h3>Content of vindesine sulfate, C<sub>43<\/sub>H<sub>55<\/sub>N<sub>5<\/sub>O<sub>7<\/sub>,H<sub>2<\/sub>SO<sub>4<\/sub><\/h3>\n<p>90.0 to 105.0% of the stated amount of anhydrous vindesine sulfate.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in methanol.<\/p>\n<p>(1) Dissolve a quantity of the contents of the injection in sufficient methanol to produce a solution containing the equivalent of 0.20% w\/v of anhydrous vindesine sulfate.<\/p>\n<p>(2) 0.20% w\/v of vindesine sulfate EPCRS.<\/p>\n<p>(3) 0.20% w\/v each of vinblastine sulfate EPCRS, vincristine sulfate EPCRS and vindesine sulfate EPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use as the coating silica gel GF254.<\/p>\n<p>(b) Use the mobile phase as described below.<\/p>\n<p>(c) Apply 10 \u03bcL of each solution.<\/p>\n<p>(d) Develop the plate to 15 cm.<\/p>\n<p>(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n<p>MOBILE PHASE<\/p>\n<p>5 volumes of diethylamine, 5 volumes of methanol and 90 volumes of chloroform.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless the chromatogram obtained with solution (3) shows three clearly separated spots.<\/p>\n<p>CONFIRMATION<\/p>\n<p>The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n<p>B. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<p>C. Yields the reactions characteristic of sulfates, Appendix VI.<\/p>\n<h2>TESTS<\/h2>\n<h3>Clarity of solution<\/h3>\n<p>Dissolve the contents of a sealed container in 10 mL of carbon dioxide-free water. The solution is clear, Appendix IV A.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in water. Keep the solutions in ice before use.<\/p>\n<p>(1) To a quantity of injection add sufficient water to produce a solution expected to contain 0.10% w\/v of anhydrous Vindesine Sulfate.<\/p>\n<p>2) Dilute 1 volume of solution (1) to 50 volumes.<\/p>\n<p>(3) Dissolve 1 mg of desacetylvinblastine EPCRS in water, add 1 mL of solution (1) and dilute to 50 mL.<\/p>\n<p>(4) Dilute 1 volume of solution (2) to 20 volumes.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Jones Apex ODS is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 2 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 270 nm.<\/p>\n<p>(f) Inject 200 \u03bcL of each solution.<\/p>\n<p>(g) Maintain the final concentration of the mobile phase until the total run time is twice the retention time of the principal peak in the chromatogram obtained with solution (1).<\/p>\n<p>MOBILE PHASE<\/p>\n<p>Mobile phase A: A 1.5% v\/v solution of diethylamine adjusted to pH 7.4 with orthophosphoric acid.<\/p>\n<p>Mobile phase B: methanol.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-22233\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Vindesine-Injection-1-300x163.jpg\" alt=\"Vindesine Injection\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Vindesine-Injection-1-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Vindesine-Injection-1-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Vindesine-Injection-1-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Vindesine-Injection-1.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n<p>the retention time of vindesine is less than 40 minutes;<\/p>\n<p>the symmetry factor of the vindesine peak is not more than 2.0;<\/p>\n<p>the resolution factor between the peaks due to vindesine and desacetylvinblastine is at least 2.0.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with the solution (1):<\/p>\n<p>the area of any secondary peak is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (3%);<\/p>\n<p>the sum of the areas of any such peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (5%).<\/p>\n<p>Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n<h4>Uniformity of content<\/h4>\n<p>The content of anhydrous vindesine sulfate in each of 10 individual containers as determined in the Assay is not less than 90.0% and not more than 110.0% of the average except that in one container the content may be not less than 80.0% and not more than 120.0% of the average.<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Keep the solutions in ice before use.<\/p>\n<p>(1) Dissolve the contents of a sealed container in water and add sufficient water to produce a solution containing the equivalent of 0.05% w\/v of anhydrous vindesine sulfate.<\/p>\n<p>(2) Dissolve and dilute the entire contents of a vial of vindesine sulfate EPCRS with water to yield a concentration of approximately 0.05% w\/v.<\/p>\n<p>(3) Add 2 mL of solution (2) to 1 mg of desacetylvinblastine EPCRS.<\/p>\n<p>CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Jones Apex ODS is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 1 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 270 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>38 volumes of a 1.5% v\/v solution of diethylamine, previously adjusted to pH 7.4 with orthophosphoric acid, and 62 volumes of methanol.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The assay is not valid unless:<\/p>\n<p>the resolution factor between the peaks corresponding to vindesine sulfate and desacetylvinblastine sulfate is greater than 1.5;<\/p>\n<p>the symmetry factor of the vindesine peak is not more than 2.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of vindesine sulfate, C<sub>43<\/sub>H<sub>55<\/sub>N<sub>5<\/sub>O<sub>7<\/sub>,H<sub>2<\/sub>SO<sub>4<\/sub>, in the container using the declared content of C<sub>43<\/sub>H<sub>55<\/sub>N<sub>5<\/sub>O<sub>7<\/sub>,H<sub>2<\/sub>SO<sub>4<\/sub><br \/>\nin vindesine sulfate EPCRS. Repeat the procedure with a further nine containers. Calculate the average content of C<sub>43<\/sub>H<sub>55<\/sub>N<sub>5<\/sub>O<sub>7<\/sub>,H<sub>2<\/sub>SO<sub>4<\/sub>\u00a0per container from the 10 individual results obtained.<\/p>\n<h2>STORAGE<\/h2>\n<p>Vindesine Sulfate for Injection should be stored at a temperature of 2\u00b0 to 8\u00b0.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed in the monograph for Vindesine Sulfate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vindesine Sulphate for Injection Action and use Vinca alkaloid cytotoxic. DEFINITION Vindesine Injection is a sterile solution of Vindesine Sulfate in a suitable liquid. It is prepared by dissolving Vindesine Sulfate for Injection in the requisite volume of a suitable diluent in accordance with the manufacturer\u2019s instructions. The injection complies with the requirements stated under&#8230;<\/p>\n","protected":false},"author":2,"featured_media":22234,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22223","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22223","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=22223"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22223\/revisions"}],"predecessor-version":[{"id":22236,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22223\/revisions\/22236"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22234"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22223"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22223"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}