{"id":8950,"date":"2025-10-04T11:40:20","date_gmt":"2025-10-04T04:40:20","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=8950"},"modified":"2025-10-04T11:41:19","modified_gmt":"2025-10-04T04:41:19","slug":"dantrolene-sodium","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/dantrolene-sodium\/","title":{"rendered":"Dantrolene Sodium"},"content":{"rendered":"

C_{14<\/sub>H_{9<\/sub>N_{4<\/sub>NaO_{5<\/sub>,3^{1<\/sup>\u2044_{2<\/sub>H_{2<\/sub>O\u00a0 \u00a0 \u00a0399.3\u00a0 \u00a0 \u00a024868-20-0<\/p>\n}}}}}}}

Action and use<\/strong><\/p>\n

Skeletal muscle relaxant.<\/p>\n

Preparation<\/strong><\/p>\n

Dantrolene Oral Suspension<\/p>\n

DEFINITION<\/h2>\n
Dantrolene Sodium is 1-(5-p-nitrophenylfurfurylideneamino)hydantoin sodium. It contains not less than 98.0% and not more than 102.0% of C_{14<\/sub>H_{9<\/sub>N_{4<\/sub>NaO_{5<\/sub>, calculated with reference to the anhydrous substance.<\/p>\n}}}}
CHARACTERISTICS<\/h2>\n
A yellowish-orange to orange crystalline powder.<\/p>\n
Very slightly soluble in water; slightly soluble in ethanol (96%); sparingly soluble in methanol; practically insoluble in acetone.<\/p>\n
IDENTIFICATION<\/h2>\n
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of dantrolene sodium (RS422).<\/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
C. To 0.1 g of the substance being examined add 20 mL of water and 2 drops of acetic acid, shake well and filter. The filtrate yields the reactions characteristic of sodium salts, Appendix VI.<\/p>\n
TESTS<\/h2>\n
Alkalinity<\/h3>\n
Shake 0.7 g in 10 mL of water for 5 minutes and centrifuge. To 5 mL of the supernatant add 45 mL of water and 3 drops of phenolphthalein solution R1 and 0.1 mL of 0.1M hydrochloric acid VS. A red colour is not produced.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dissolve 50 mg of the substance being examined 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. Further dilute 10 mL of this solution to 100 mL with absolute ethanol.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\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
MOBILE PHASE<\/h4>\n
9 volumes of absolute ethanol, 10 volumes of glacial acetic acid and 90 volumes of hexane.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks
\ncorresponding to theophylline and dantrolene is at least 6.<\/p>\n
LIMITS<\/h4>\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
Water<\/h4>\n
14.5 to 17.0% w\/w, Appendix IX C. Use 0.2 g<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dissolve 60 mg of the substance being examined in 50 mL of dimethylformamide and dilute 1 volume of the resulting solution to 100 volumes with the mobile phase.
\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
CHROMATOGRAPHIC CONDITIONS<\/h3>\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
MOBILE PHASE<\/h3>\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
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{14<\/sub>H_{9<\/sub>N_{4<\/sub>NaO_{5<\/sub> in the substance being examined using the declared content of C_{14<\/sub>H_{9<\/sub>N_{4<\/sub>NaO_{5<\/sub> in dantrolene sodium BPCRS.<\/p>\n","protected":false},"excerpt":{"rendered":"}}}}}}}}
C14H9N4NaO5,31\u20442H2O\u00a0 \u00a0 \u00a0399.3\u00a0 \u00a0 \u00a024868-20-0 Action and use Skeletal muscle relaxant. Preparation Dantrolene Oral Suspension DEFINITION Dantrolene Sodium is 1-(5-p-nitrophenylfurfurylideneamino)hydantoin sodium. It contains not less than 98.0% and not more than 102.0% of C14H9N4NaO5, calculated with reference to the anhydrous substance. CHARACTERISTICS A yellowish-orange to orange crystalline powder. Very slightly soluble in water; slightly soluble…<\/p>\n","protected":false},"author":3,"featured_media":8953,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-8950","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/8950","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=8950"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/8950\/revisions"}],"predecessor-version":[{"id":8965,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/8950\/revisions\/8965"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/8953"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=8950"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=8950"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=8950"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

CHARACTERISTICS<\/h2>\nA yellowish-orange to orange crystalline powder.<\/p>\nVery slightly soluble in water; slightly soluble in ethanol (96%); sparingly soluble in methanol; practically insoluble in acetone.<\/p>\n

TESTS<\/h2>\n

Alkalinity<\/h3>\nShake 0.7 g in 10 mL of water for 5 minutes and centrifuge. To 5 mL of the supernatant add 45 mL of water and 3 drops of phenolphthalein solution R1 and 0.1 mL of 0.1M hydrochloric acid VS. A red colour is not produced.<\/p>\n

MOBILE PHASE<\/h4>\n9 volumes of absolute ethanol, 10 volumes of glacial acetic acid and 90 volumes of hexane.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks\ncorresponding to theophylline and dantrolene is at least 6.<\/p>\n

LIMITS<\/h4>\nIn the chromatogram obtained with solution (1):<\/p>\nthe 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

Water<\/h4>\n14.5 to 17.0% w\/w, Appendix IX C. Use 0.2 g<\/p>\n

MOBILE PHASE<\/h3>\n15 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

CHARACTERISTICS<\/h2>\n
A yellowish-orange to orange crystalline powder.<\/p>\n
Very slightly soluble in water; slightly soluble in ethanol (96%); sparingly soluble in methanol; practically insoluble in acetone.<\/p>\n

Alkalinity<\/h3>\n
Shake 0.7 g in 10 mL of water for 5 minutes and centrifuge. To 5 mL of the supernatant add 45 mL of water and 3 drops of phenolphthalein solution R1 and 0.1 mL of 0.1M hydrochloric acid VS. A red colour is not produced.<\/p>\n

MOBILE PHASE<\/h4>\n
9 volumes of absolute ethanol, 10 volumes of glacial acetic acid and 90 volumes of hexane.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks
\ncorresponding to theophylline and dantrolene is at least 6.<\/p>\n

LIMITS<\/h4>\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

Water<\/h4>\n
14.5 to 17.0% w\/w, Appendix IX C. Use 0.2 g<\/p>\n

MOBILE PHASE<\/h3>\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