\u200b\u200b\u200b\u200b\u200b\u200b\u200bEdition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Diazoxide Tablets<\/p>\n
General Notices<\/p>\n
Action and use\u00a0<\/strong><\/p>\n Vasodilator; treatment of hypertension.<\/p>\n Diazoxide Tablets contain Diazoxide.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n Content of diazoxide, C8<\/sub>H7<\/sub>ClN2<\/sub>O2<\/sub>S<\/strong><\/p>\n 92.5 to 107.5% of the stated amount.<\/p>\n Shake a quantity of the powdered tablets containing 0.2 g of Diazoxide with 50 mL of absolute ethanol, filter and evaporate the filtrate to dryness at a pressure of 2 kPa. The residue complies with the following tests.<\/p>\n A.\u2003The light absorption, Appendix II B, in the range 230 to 350 nm of a 0.001% w\/v solution in 0.1M sodium hydroxide exhibits a maximum only at 280 nm.<\/p>\n B.\u2003Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (1)\u20030.02% w\/v of the residue in methanol.<\/p>\n (2)\u20030.02% w\/v of diazoxide EPCRS in methanol.<\/p>\n (a)\u2003Use silica gel GF254 as the coating.<\/p>\n (b)\u2003Use the mobile phase as described below.<\/p>\n (c)\u2003Apply 20 \u00b5L of each solution.<\/p>\n (d)\u2003Develop the plate to 15 cm.<\/p>\n (e)\u2003After removal of the plate, dry in air until the solvent has evaporated, examine under ultraviolet light (254 nm) and then treat the plate by Method I and examine again.<\/p>\n 20 volumes of acetone, 30 volumes of ether, and 50 volumes of toluene.<\/p>\n The principal spot in the chromatogram obtained with solution (1) corresponds in colour and intensity to that in the chromatogram obtained with solution (2).<\/p>\n Related substances\u00a0<\/strong><\/p>\n Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1)\u2003Shake a quantity of the powdered tablets containing 0.75 g of Diazoxide with 40 mL of 0.1M sodium hydroxide for 30 minutes, filter and dilute the filtrate to 50 mL with 0.1M sodium hydroxide.<\/p>\n (2)\u2003Dilute 1 volume of solution (1) to 200 volumes with 0.1M sodium hydroxide.<\/p>\n (a)\u2003Use a TLC silica gel GF254 plate.<\/p>\n (b)\u2003Use the mobile phase as described below.<\/p>\n (c)\u2003Apply 5 \u00b5L of each solution.<\/p>\n (d)\u2003Develop the plate to 15 cm.<\/p>\n (e)\u2003After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n 7 volumes of 18M ammonia, 25 volumes of methanol and 68 volumes of chloroform.<\/p>\n Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%).<\/p>\n Weigh and powder 20 tablets. To a quantity of the powder containing 50 mg of Diazoxide add 70 mL of methanol, shake for 1 hour, add sufficient methanol to produce 100 mL, mix and filter. Dilute 5 mL of the filtrate to 250 mL with 0.1M sodium hydroxide and measure the absorbance of the resulting solution at the maximum at 280 nm, Appendix II B. Calculate the content of C8<\/sub>H7<\/sub>ClN2<\/sub>O2<\/sub>S taking 585 as the value of A(1%, 1 cm) at the maximum at 280 nm.<\/p>\n","protected":false},"excerpt":{"rendered":" \u200b\u200b\u200b\u200b\u200b\u200b\u200bEdition: BP 2025 (Ph. Eur. 11.6 update) Diazoxide Tablets General Notices Action and use\u00a0 Vasodilator; treatment of hypertension. DEFINITION Diazoxide Tablets contain Diazoxide. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of diazoxide, C8H7ClN2O2S 92.5 to 107.5% of the stated amount. IDENTIFICATION Shake a quantity of the powdered…<\/p>\n","protected":false},"author":5,"featured_media":17183,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-17182","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\/17182","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=17182"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17182\/revisions"}],"predecessor-version":[{"id":17194,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17182\/revisions\/17194"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17183"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17182"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17182"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17182"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
CONFIRMATION<\/h3>\n
TESTS<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
LIMITS<\/h3>\n
ASSAY<\/h2>\n