Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Diazoxide Injection<\/p>\n
General Notices<\/p>\n
Action and use\u00a0<\/strong><\/p>\n Vasodilator; treatment of hypertension.<\/p>\n Diazoxide Injection is a sterile solution of Diazoxide in Water for Injections, prepared with the aid of Sodium Hydroxide. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n Content of diazoxide, C8<\/sub>H7<\/sub>ClN2<\/sub>O2<\/sub>S\u00a0<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A colourless solution.<\/p>\n To a volume containing 0.3 g of Diazoxide add 2 mL of 2M hydrochloric acid, stir, filter the precipitate and wash the filter thoroughly with water until the filtrate is free from acid. The precipitate, after drying at 105\u00b0, complies with the following tests.<\/p>\n A.\u2003The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of diazoxide (RS 094). B.\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 C.\u2003Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (1)\u2003Use the injection, diluted if necessary, with methanol to contain 0.02% w\/v of Diazoxide. (2)\u20030.02% w\/v of diazoxide EPCRS in methanol.<\/p>\n (a)\u2003Use as the coating silica gel GF254.<\/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, allow it to 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 position and colour to that in the chromatogram obtained with solution (2).<\/p>\n pH, 11.2 to 11.9, Appendix V L.<\/p>\n Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1)\u2003Use the injection diluted, if necessary, with 0.1M sodium hydroxide to contain 1.5% w\/v of Diazoxide. (2)\u2003Dilute 1 volume of solution (1) to 200 volumes with 0.1M sodium hydroxide.<\/p>\n (a)\u2003Use as the coating silica gel GF254.<\/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, allow it to 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 To a volume containing 75 mg of Diazoxide add sufficient 0.1M sodium hydroxide to produce 500 mL. Dilute 5 mL to 100 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 Diazoxide Injection should be protected from light.\u00a0\u200b\u200b\u200b\u200b\u200b\u200b\u200b<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Diazoxide Injection General Notices Action and use\u00a0 Vasodilator; treatment of hypertension. DEFINITION Diazoxide Injection is a sterile solution of Diazoxide in Water for Injections, prepared with the aid of Sodium Hydroxide. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of…<\/p>\n","protected":false},"author":5,"featured_media":17180,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-16881","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\/16881","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=16881"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16881\/revisions"}],"predecessor-version":[{"id":17188,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16881\/revisions\/17188"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17180"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16881"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16881"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16881"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERISTICS<\/h2>\n
IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
CONFIRMATION<\/h3>\n
TESTS<\/h2>\n
Alkalinity<\/h3>\n
Related substances<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n