{"id":30863,"date":"2025-11-12T15:49:58","date_gmt":"2025-11-12T08:49:58","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=30863"},"modified":"2025-11-12T15:49:58","modified_gmt":"2025-11-12T08:49:58","slug":"ursodoxicoltaurine-dihydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/ursodoxicoltaurine-dihydrate\/","title":{"rendered":"Ursodoxicoltaurine Dihydrate"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

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

Bile acid derivative; prevention and treatment of gallstone formation.<\/p>\n

DEFINITION<\/h2>\n
2-(3\u03b1,7\u03b2-Dihydroxy-5\u03b2-cholan-24-amido)ethane-1-sulfonic acid dihydrate.<\/p>\n
Content<\/strong><\/p>\n
98.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, microcrystalline powder.<\/p>\n
Solubility<\/h3>\n
Very slightly soluble in water, freely soluble in ethanol (96 per cent), soluble in acetone, slightly soluble in methylene chloride.<\/p>\n
IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison\u00a0 ursodoxicoltaurine dihydrate CRS.<\/p>\n
TESTS<\/h2>\n
Specific optical rotation (2.2.7)<\/strong><\/p>\n
+ 35.5 to + 37.5.<\/p>\n
Dissolve 0.500 g in water R and dilute to 25.0 mL with the same solvent. To improve dissolution, the solution may be heated to about 60 \u00b0C and then cooled to about 20 \u00b0C.<\/p>\n
Impurity C<\/h3>\n
Thin-layer chromatography (2.2.27).<\/p>\n
Solvent mixture\u00a0 anhydrous ethanol R, water R (50:50 V\/V).<\/p>\n
Test solution Dissolve 1.000 g of the substance to be examined in 8 mL of the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n
Reference solution Dissolve 10 mg of taurine CRS (impurity C) in the solvent mixture and dilute to 5.0 mL with the solvent mixture. Dilute 1.0 mL of the solution to 10.0 mL with the solvent mixture.<\/p>\n
Plate\u00a0 TLC silica gel F254 plate R.<\/p>\n
Mobile phase methanol R, water R, anhydrous ethanol R (40:40:80 V\/V\/V). Application 10 \u00b5L.<\/p>\n
Development\u00a0 Over 3\/4 of the plate.<\/p>\n
Drying\u00a0 In an oven at 130 \u00b0C.<\/p>\n
Detection\u00a0 Spray with ninhydrin solution R4 and heat in an oven at 130 \u00b0C for at least 10 min.<\/p>\n
Limit:<\/p>\n
\u2014 impurity C: any spot due to impurity C is not more intense than the principal spot in the chromatogram obtained with the reference solution (0.2 per cent).<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Solvent mixture\u00a0 water R, anhydrous ethanol R (20:80 V\/V).<\/p>\n
Test solution (a) Dissolve 0.100 g of the substance to be examined in 8 mL of the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n
Test solution (b)\u00a0 Dilute 1.0 mL of test solution (a) to 20.0 mL with the solvent mixture.<\/p>\n
Reference solution (a) Dilute 1.0 mL of test solution (a) to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n
Reference solution (b)\u00a0 Dissolve 10.0 mg of ursodoxicoltaurine impurity A CRS in the solvent mixture and dilute to 10.0 mL with the solvent mixture. Dilute 1.0 mL of the solution to 20.0 mL with the solvent mixture.<\/p>\n
Reference solution (c) Dissolve 5 mg of ursodoxicoltaurine for impurity B identification CRS in the solvent mixture and dilute to 0.5 mL with the solvent mixture.<\/p>\n
Reference solution (d) Dissolve 5.0 mg of ursodoxicoltaurine dihydrate CRS in the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m);<\/p>\n
\u2014 temperature: 35 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: dissolve 1.36 g of potassium dihydrogen phosphate R in 1000 mL of water for chromatography R and adjust to pH 3.0 with phosphoric acid R;<\/p>\n
\u2014 mobile phase B: acetonitrile R1;<\/p>\n\n\n\n\n\n\n\n\n
Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 5<\/td>\n 70<\/td>\n 30<\/td>\n<\/tr>\n
5 – 14<\/td>\n 70 \u2192 47<\/td>\n 30 \u2192 53<\/td>\n<\/tr>\n
14 – 22<\/td>\n 47 \u2192 45<\/td>\n 53 \u2192 55<\/td>\n<\/tr>\n
22 – 23<\/td>\n 45 \u2192 30<\/td>\n 55 \u2192 70<\/td>\n<\/tr>\n
23 – 27<\/td>\n 30<\/td>\n 70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate\u00a0 1.2 mL\/min.<\/p>\n
Detection\u00a0 Spectrophotometer at 195 nm.<\/p>\n
Autosampler\u00a0 Set at 10 \u00b0C.<\/p>\n
Injection\u00a0 10 \u00b5L of test solution (a) and reference solutions (a), (b) and (c).<\/p>\n
Identification of impurities\u00a0 Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity A; use the chromatogram supplied with ursodoxicoltaurine for impurity B identification CRS and the chromatogram obtained with reference solution (c) to identify the peak due to impurity B.<\/p>\n
Relative retention With reference to ursodoxicoltaurine (retention time = about 9 min): impurity B = about 1.7; impurity A = about 2.0.<\/p>\n
System suitability\u00a0 Reference solution (c):<\/p>\n
\u2014 resolution: minimum 5.0 between the peaks due to ursodoxicoltaurine and impurity B.<\/p>\n
Calculation of percentage contents:<\/p>\n
\u2014 for impurity A, use the concentration of impurity A in reference solution (b);<\/p>\n
\u2014 for impurities other than A, use the concentration of ursodoxicoltaurine dihydrate in reference solution (a).<\/p>\n
Limits:<\/p>\n
\u2014 impurities A and B: for each impurity, maximum 0.5 per cent;<\/p>\n
\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n
\u2014 total: maximum 1.5 per cent;<\/p>\n
\u2014 reporting threshold: 0.05 per cent.<\/p>\n
Water (2.5.12)<\/strong><\/p>\n
6.0 per cent to 8.0 per cent, determined on 0.200 g.<\/p>\n
Sulfated ash (2.4.14)<\/strong><\/p>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Liquid chromatography (2.2.29) as described in the test for related substances with the following modifications.<\/p>\n
Injection\u00a0 5 \u00b5L of test solution (b) and reference solution (d).<\/p>\n
System suitability\u00a0 Reference solution (d):<\/p>\n
\u2014 symmetry factor: maximum 2.5 for the peak due to ursodoxicoltaurine.<\/p>\n
Calculate the percentage content of C_{26<\/sub>H_{45<\/sub>NO_{6<\/sub>S taking into account the assigned content of ursodoxicoltaurine dihydrate CRS.<\/p>\n}}}
IMPURITIES<\/h2>\n
Specified impurities\u00a0 A, B, C.<\/em><\/p>\n
A. 3\u03b1,7\u03b2-dihydroxy-5\u03b2-cholan-24-oic acid (ursodeoxycholic acid),<\/p>\n
B. 2-(3\u03b1,7\u03b1-dihydroxy-5\u03b2-cholan-24-amido)ethane-1-sulfonic acid (taurochenodeoxycholic acid),<\/p>\n
C. 2-aminoethane-1-sulfonic acid (taurine).<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Bile acid derivative; prevention and treatment of gallstone formation. DEFINITION 2-(3\u03b1,7\u03b2-Dihydroxy-5\u03b2-cholan-24-amido)ethane-1-sulfonic acid dihydrate. Content 98.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, microcrystalline powder. Solubility Very slightly soluble in water, freely soluble in ethanol (96 per cent), soluble…<\/p>\n","protected":false},"author":5,"featured_media":30864,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-30863","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\/30863","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=30863"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30863\/revisions"}],"predecessor-version":[{"id":30872,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30863\/revisions\/30872"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/30864"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=30863"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=30863"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=30863"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (min)<\/strong><\/td>\n	Mobile phase A (per cent V\/V)<\/strong><\/td>\n	Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 5<\/td>\n	70<\/td>\n	30<\/td>\n<\/tr>\n
5 – 14<\/td>\n	70 \u2192 47<\/td>\n	30 \u2192 53<\/td>\n<\/tr>\n
14 – 22<\/td>\n	47 \u2192 45<\/td>\n	53 \u2192 55<\/td>\n<\/tr>\n
22 – 23<\/td>\n	45 \u2192 30<\/td>\n	55 \u2192 70<\/td>\n<\/tr>\n
23 – 27<\/td>\n	30<\/td>\n	70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate\u00a0 1.2 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 195 nm.<\/p>\n Autosampler\u00a0 Set at 10 \u00b0C.<\/p>\n Injection\u00a0 10 \u00b5L of test solution (a) and reference solutions (a), (b) and (c).<\/p>\n Identification of impurities\u00a0 Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity A; use the chromatogram supplied with ursodoxicoltaurine for impurity B identification CRS and the chromatogram obtained with reference solution (c) to identify the peak due to impurity B.<\/p>\n Relative retention With reference to ursodoxicoltaurine (retention time = about 9 min): impurity B = about 1.7; impurity A = about 2.0.<\/p>\n System suitability\u00a0 Reference solution (c):<\/p>\n \u2014 resolution: minimum 5.0 between the peaks due to ursodoxicoltaurine and impurity B.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 for impurity A, use the concentration of impurity A in reference solution (b);<\/p>\n \u2014 for impurities other than A, use the concentration of ursodoxicoltaurine dihydrate in reference solution (a).<\/p>\n Limits:<\/p>\n \u2014 impurities A and B: for each impurity, maximum 0.5 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 1.5 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Water (2.5.12)<\/strong><\/p>\n 6.0 per cent to 8.0 per cent, determined on 0.200 g.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n ASSAY<\/h2>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modifications.<\/p>\n Injection\u00a0 5 \u00b5L of test solution (b) and reference solution (d).<\/p>\n System suitability\u00a0 Reference solution (d):<\/p>\n \u2014 symmetry factor: maximum 2.5 for the peak due to ursodoxicoltaurine.<\/p>\n Calculate the percentage content of C_{26<\/sub>H_{45<\/sub>NO_{6<\/sub>S taking into account the assigned content of ursodoxicoltaurine dihydrate CRS.<\/p>\n}}} IMPURITIES<\/h2>\n Specified impurities\u00a0 A, B, C.<\/em><\/p>\n A. 3\u03b1,7\u03b2-dihydroxy-5\u03b2-cholan-24-oic acid (ursodeoxycholic acid),<\/p>\n B. 2-(3\u03b1,7\u03b1-dihydroxy-5\u03b2-cholan-24-amido)ethane-1-sulfonic acid (taurochenodeoxycholic acid),<\/p>\n C. 2-aminoethane-1-sulfonic acid (taurine).<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Bile acid derivative; prevention and treatment of gallstone formation. DEFINITION 2-(3\u03b1,7\u03b2-Dihydroxy-5\u03b2-cholan-24-amido)ethane-1-sulfonic acid dihydrate. Content 98.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, microcrystalline powder. Solubility Very slightly soluble in water, freely soluble in ethanol (96 per cent), soluble…<\/p>\n","protected":false},"author":5,"featured_media":30864,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-30863","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\/30863","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=30863"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30863\/revisions"}],"predecessor-version":[{"id":30872,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30863\/revisions\/30872"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/30864"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=30863"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=30863"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=30863"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Appearance<\/h3>\nWhite or almost white, microcrystalline powder.<\/p>\n

Solubility<\/h3>\nVery slightly soluble in water, freely soluble in ethanol (96 per cent), soluble in acetone, slightly soluble in methylene chloride.<\/p>\n

IDENTIFICATION<\/h2>\nInfrared absorption spectrophotometry (2.2.24).<\/p>\nComparison\u00a0 ursodoxicoltaurine dihydrate CRS.<\/p>\n

TESTS<\/h2>\nSpecific optical rotation (2.2.7)<\/strong><\/p>\n+ 35.5 to + 37.5.<\/p>\nDissolve 0.500 g in water R and dilute to 25.0 mL with the same solvent. To improve dissolution, the solution may be heated to about 60 \u00b0C and then cooled to about 20 \u00b0C.<\/p>\n

Appearance<\/h3>\n
White or almost white, microcrystalline powder.<\/p>\n

Solubility<\/h3>\n
Very slightly soluble in water, freely soluble in ethanol (96 per cent), soluble in acetone, slightly soluble in methylene chloride.<\/p>\n

IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison\u00a0 ursodoxicoltaurine dihydrate CRS.<\/p>\n

TESTS<\/h2>\n
Specific optical rotation (2.2.7)<\/strong><\/p>\n
+ 35.5 to + 37.5.<\/p>\n
Dissolve 0.500 g in water R and dilute to 25.0 mL with the same solvent. To improve dissolution, the solution may be heated to about 60 \u00b0C and then cooled to about 20 \u00b0C.<\/p>\n