(Ph. Eur. 11.6 update)<\/p>\n
NOTE: This monograph has been developed to cover unlicensed formulations.<\/p>\n
Action and use<\/strong><\/p>\n Skeletal muscle relaxant.<\/p>\n Dantrolene Oral Suspension is a suspension of Dantrolene Sodium in a suitable flavoured vehicle.<\/p>\n The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements. Where appropriate, the oral suspension also complies with the requirements stated under Unlicensed Medicines.<\/p>\n Content of dantrolene sodium, C14<\/sub>H9<\/sub>N4<\/sub>NaO5<\/sub>,3 1\u20442H2O<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n Shake the oral suspension vigorously before carrying out the following tests.<\/p>\n A. Shake a quantity of the oral suspension containing 0.1 g of Dantrolene Sodium with sufficient 0.01M sodium hydroxide to produce 100 mL, dilute 1 mL to 100 mL with 0.01M sodium hydroxide, filter and use the filtrate. The light absorption, Appendix II B, in the range 230 nm to 350 nm, of the final solution, exhibits a maximum at 314 nm.<\/p>\n B. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n pH, 4.5 to 5.5, Appendix V L.<\/p>\n Complies with the requirements stated under Unlicensed Medicines, Oral Suspensions. Use a volume of the oral suspension containing one dose.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dissolve a quantity of the oral suspension containing 50 mg of Dantrolene Sodium in 20 mL of tetrahydrofuran and 2 mL of glacial acetic acid and dilute with sufficient absolute ethanol to produce 100 mL.<\/p>\n (2) Dilute 1 mL of solution (1) to 100 mL with absolute ethanol.<\/p>\n (3) Dissolve 5 mg of dantrolene sodium BPCRS and 0.1 g of theophylline BPCRS in 20 mL of tetrahydrofuran and 2 mL of glacial acetic acid and dilute with sufficient absolute ethanol to produce 100 mL. Dilute 10 mL of the resulting solution to\u00a0 100 mL with absolute ethanol.<\/p>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with silica gel for chromatography (5 \u03bcm) (Zorbax Sil is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Adjust the flow rate of the mobile phase so that the retention time of the peak corresponding to dantrolene sodium is about 8 minutes.<\/p>\n (d) Use a column temperature of 30\u00b0.<\/p>\n (e) Use a detection wavelength of 300 nm.<\/p>\n (f) Inject 10 \u03bcL of each solution.<\/p>\n (g) For solution (1) allow the chromatography to proceed for at least twice the retention time of the principal peak.<\/p>\n 9 volumes of absolute ethanol, 10 volumes of glacial acetic acid and 90 volumes of hexane.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to theophylline and dantrolene is at least 6.0.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the total area of all the secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%).<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Add 50 mL of dimethylformamide to a weighed quantity of the oral suspension containing 60 mg of Dantrolene Sodium and dilute 1 volume of this solution to 100 volumes with the mobile phase.<\/p>\n (2) Dilute 1 volume of a 0.12% w\/v solution of dantrolene sodium BPCRS in dimethylformamide to 100 volumes with the mobile phase.<\/p>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with spherical particles of silica, 5 \u03bcm in diameter, the surface of which has been modified with chemically-bonded nitrile groups (Spherisorb CN is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 262 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n 15 volumes of acetonitrile and 85 volumes of a phosphate buffer pH 6.8 prepared by dissolving 11.88 g of disodium hydrogen orthophosphate and 9.08 g of potassium dihydrogen orthophosphate in 1000 mL of water.<\/p>\n Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of C14<\/sub>H9<\/sub>N4<\/sub>NaO5<\/sub>,3 1\u20442H2O, weight in volume, using the declared content of C14<\/sub>H9<\/sub>N4<\/sub>NaO5<\/sub> in dantrolene sodium BPCRS. Each mg of C14<\/sub>H9<\/sub>N4<\/sub>NaO5<\/sub> is equivalent to 1.1873 mg of C14<\/sub>H9<\/sub>N4<\/sub>NaO5<\/sub>,3 1\u20442H2O.<\/p>\n Dantrolene Oral Suspension should be protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) NOTE: This monograph has been developed to cover unlicensed formulations. Action and use Skeletal muscle relaxant. DEFINITION Dantrolene Oral Suspension is a suspension of Dantrolene Sodium in a suitable flavoured vehicle. The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements. Where appropriate, the oral…<\/p>\n","protected":false},"author":5,"featured_media":12778,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-12775","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\/12775","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=12775"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12775\/revisions"}],"predecessor-version":[{"id":12786,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12775\/revisions\/12786"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/12778"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=12775"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=12775"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=12775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Acidity<\/h3>\n
Dissolution<\/h3>\n
Related substances<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
SYSTEM SUITABILITY<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
STORAGE<\/h2>\n