Tioconazole Cutaneous Solution<\/p>\n
Action and use<\/strong><\/p>\n Antifungal.<\/p>\n Tioconazole Nail Solution is a cutaneous solution. It contains Tioconazole in a suitable vehicle.<\/p>\n The nail solution complies with the requirements stated under Liquids for Cutaneous Application and with the following requirements.<\/p>\n Content of tioconazole, C16<\/sub>H13<\/sub>Cl3<\/sub>N2<\/sub>OS<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1) Dilute a quantity of the nail solution containing 28 mg of Tioconazole to 10 mL with methanol.<\/p>\n (2) 0.28% w\/v solution of tioconazole BPCRS in methanol.<\/p>\n (a) Use as the coating silica gel 60 F254 (Merck silica gel 60 F254 plates are suitable).<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 10 \u03bcL of each solution.<\/p>\n (d) Develop the plate to 15 cm.<\/p>\n (e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n The upper layer obtained from a mixture of 40 volumes of glacial acetic acid, 40 volumes of water and 80 volumes 4- methylpentan-2-one.<\/p>\n 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 B. In the test for Related substances, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (5).<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/p>\n (1) Dilute a quantity of the nail solution containing 20 mg of Tioconazole to 10 mL.<\/p>\n (2) Dilute 1 volume of solution (1) to 10 volumes.<\/p>\n (3) Dilute 1 volume of solution (2) to 20 volumes.<\/p>\n (4) 0.20% w\/v of tioconazole impurity standard BPCRS.<\/p>\n (5) 0.02% w\/v of tioconazole BPCRS.<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil ODS is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.0 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 218 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n 1 volume of 0.005M tetrabutylammonium dihydrogen orthophosphate adjusted to pH 7.4 with 2M ammonia and 4 volumes of methanol.<\/p>\n The test is not valid unless the chromatogram obtained with solution (4) closely resembles the reference chromatogram supplied with tioconazole impurity standard BPCRS.<\/p>\n In the chromatogram obtained with solution (1): the areas of any peaks corresponding to tioconazole impurities A, B and C are not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.5% of each).<\/p>\n Carry out Method I for non-aqueous titration, Appendix VIII A, using a quantity of the nail solution containing 0.28 g of Tioconazole. Each mL of 0.1M perchloric acid VS is equivalent to 38.77 mg of C16<\/sub>H13<\/sub>Cl3<\/sub>N2<\/sub>OS. Determine the weight per mL of the nail solution, Appendix V G, and calculate the content of C16<\/sub>H13<\/sub>Cl3<\/sub>N2<\/sub>OS, weight in volume.<\/p>\n","protected":false},"excerpt":{"rendered":" Tioconazole Cutaneous Solution Action and use Antifungal. DEFINITION Tioconazole Nail Solution is a cutaneous solution. It contains Tioconazole in a suitable vehicle. The nail solution complies with the requirements stated under Liquids for Cutaneous Application and with the following requirements. Content of tioconazole, C16H13Cl3N2OS 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out…<\/p>\n","protected":false},"author":4,"featured_media":21308,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21306","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\/21306","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=21306"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21306\/revisions"}],"predecessor-version":[{"id":21310,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21306\/revisions\/21310"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21308"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21306"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21306"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
CONFIRMATION<\/h4>\n
TESTS<\/h2>\n
Related substances<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
SYSTEM SUITABILITY<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n