{"id":21288,"date":"2025-10-28T11:44:44","date_gmt":"2025-10-28T04:44:44","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=21288"},"modified":"2025-10-29T08:39:35","modified_gmt":"2025-10-29T01:39:35","slug":"solifenacin-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/solifenacin-oral-solution\/","title":{"rendered":"Solifenacin Oral Solution"},"content":{"rendered":"

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

Muscarinic M_{3<\/sub> receptor antagonist; anticholinergic.<\/p>\n}

DEFINITION<\/h2>\n
Solifenacin Oral Solution is a solution of Solifenacin Succinate in a suitable flavoured vehicle.
\nThe oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n
Content of solifenacin succinate, C_{27<\/sub>H_{32<\/sub>N_{2<\/sub>O_{6<\/sub><\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with solutions (1) and (2) with a diode array detector in the range of 210 to 400 nm.<\/p>\n
The UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant with that of the peak in the chromatogram obtained with solution (2);<\/p>\n
the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following freshly prepared solutions.<\/p>\n
Solution A: 20 volumes of acetonitrile R1 and 30 volumes of 0.1M hydrochloric acid.<\/p>\n
(1) To a quantity of the oral solution containing 6 mg of Solifenacin Succinate add 30 mL of solution A, shake and dilute to 50 mL with solution A.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes with solution A. Further dilute 1 volume of this solution to 5 volumes with solution A.<\/p>\n
(3) To 10 mg of solifenacin succinate BPCRS add 1 mL of hydrogen peroxide (30%), 5 mL of 0.1M sodium hydroxide, 10 mL of water and 5 mL of acetonitrile. Stir uncovered for 10 minutes (generation of impurity I). Add 1 volume of this solution to 2.5 volumes of solution (1) and dilute to 25 volumes with solution A.<\/p>\n
(4) 0.1% w\/v of solifenacin succinate impurity standard BPCRS (containing impurities A and 1) in solution A.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (3.5 \u03bcm) (Waters XTerra MS C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/p>\n
(e) Use an autosampler temperature of 5\u00b0.<\/p>\n
(f) Use a detection wavelength of 210 nm.<\/p>\n
(g) Inject 15 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
Mobile phase A: 20 volume of acetonitrile R1 and 80 volumes of a 0.05M ammonium dihydrogen orthophosphate solution previously adjusted to pH 2.4 with orthophosphoric acid.<\/p>\n
Mobile phase B: Acetonitrile R1.<\/p>\n\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/strong><\/td>\n Mobile phase A (% v\/v)<\/strong><\/td>\n Mobile phase B (% v\/v)<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-25<\/td>\n 95-90<\/td>\n 5-10<\/td>\n linear gradient<\/td>\n<\/tr>\n
25-40<\/td>\n 90-75<\/td>\n 10-25<\/td>\n linear gradient<\/td>\n<\/tr>\n
40-41<\/td>\n 75-50<\/td>\n 25-50<\/td>\n linear gradient<\/td>\n<\/tr>\n
41-65<\/td>\n 50<\/td>\n 50<\/td>\n isocratic<\/td>\n<\/tr>\n
65-66<\/td>\n 50-95<\/td>\n 50-5<\/td>\n linear gradient<\/td>\n<\/tr>\n
66-75<\/td>\n 95<\/td>\n 5<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to solifenacin and impurity I is at least 2.0.<\/p>\n
CALCULATION OF IMPURITIES<\/p>\n
For each impurity, use the concentration of solifenacin succinate in solution (2).<\/p>\n
For the reporting threshold, use the concentration of solifenacin succinate in solution (2).<\/p>\n
For peak identification, use solutions (3) and (4).<\/p>\n
Solifenacin succinate retention time: about 26 minutes.<\/p>\n
Relative retention: impurity A, about 0.2; impurity 1, about 0.5; impurity I, about 1.1.<\/p>\n
Correction factor: impurity A, multiply by 0.7.<\/p>\n
LIMITS<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 0.2%;<\/p>\n
\u2014 total impurities: not more than 0.5%;<\/p>\n
\u2014 reporting threshold: 0.1%.<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions freshly prepared in solution A.<\/p>\n
(1) To a weighed amount of the oral solution containing 6 mg of Solifenacin Succinate, add in 30 mL, shake and dilute to produce 50 mL. Dilute 1 volume of this solution to 10 volumes.<\/p>\n
(2) 0.0012% w\/v of solifenacin succinate BPCRS.<\/p>\n
(3) 0.0012% w\/v of solifenacin succinate BPCRS and 0.00024% w\/v of propyl 4-hydroxybenzoate.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl amorphous organosilica polymer for chromatography (3.5 \u03bcm) (Waters XTerra MS C18 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 a column temperature of 40\u00b0.<\/p>\n
(e) Use an autosampler temperature of 5\u00b0.<\/p>\n
(f) Use a detection wavelength of 210 nm.<\/p>\n
(g) Inject 25 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
30 volumes of acetonitrile R1 and 70 volumes of a 0.05M ammonium dihydrogen orthophosphate solution previously adjusted to pH 2.4 with orthophosphoric acid.<\/p>\n
When the chromatograms are recorded under the prescribed conditions the retention time of the solifenacin is about 11 minutes.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to solifenacin and propyl 4-hydroxybenzoate is at least 1.5.<\/p>\n
DETERMINATION OF CONTENT<\/p>\n
Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C_{27<\/sub>H_{32<\/sub>N_{2<\/sub>O_{6<\/sub>, weight in volume, using the declared content of C_{27<\/sub>H_{32<\/sub>N_{2<\/sub>O_{6<\/sub> in solifenacin succinate BPCRS.<\/p>\n}}}}}}}}
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include impurity I listed under Solifenacin Succinate and:<\/p>\n
$\"Solifenacin$ <\/p>\n
1. (+)-(R)-quinuclidin-3-yl [2-(2-benzoylphenyl)ethyl]carbamate<\/p>\n","protected":false},"excerpt":{"rendered":"
Action and use Muscarinic M3 receptor antagonist; anticholinergic. DEFINITION Solifenacin Oral Solution is a solution of Solifenacin Succinate in a suitable flavoured vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of solifenacin succinate, C27H32N2O6 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay,…<\/p>\n","protected":false},"author":2,"featured_media":21297,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21288","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\/21288","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=21288"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21288\/revisions"}],"predecessor-version":[{"id":21715,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21288\/revisions\/21715"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21297"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21288"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21288"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21288"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/strong><\/td>\n	Mobile phase A (% v\/v)<\/strong><\/td>\n	Mobile phase B (% v\/v)<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-25<\/td>\n	95-90<\/td>\n	5-10<\/td>\n	linear gradient<\/td>\n<\/tr>\n
25-40<\/td>\n	90-75<\/td>\n	10-25<\/td>\n	linear gradient<\/td>\n<\/tr>\n
40-41<\/td>\n	75-50<\/td>\n	25-50<\/td>\n	linear gradient<\/td>\n<\/tr>\n
41-65<\/td>\n	50<\/td>\n	50<\/td>\n	isocratic<\/td>\n<\/tr>\n
65-66<\/td>\n	50-95<\/td>\n	50-5<\/td>\n	linear gradient<\/td>\n<\/tr>\n
66-75<\/td>\n	95<\/td>\n	5<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to solifenacin and impurity I is at least 2.0.<\/p>\n CALCULATION OF IMPURITIES<\/p>\n For each impurity, use the concentration of solifenacin succinate in solution (2).<\/p>\n For the reporting threshold, use the concentration of solifenacin succinate in solution (2).<\/p>\n For peak identification, use solutions (3) and (4).<\/p>\n Solifenacin succinate retention time: about 26 minutes.<\/p>\n Relative retention: impurity A, about 0.2; impurity 1, about 0.5; impurity I, about 1.1.<\/p>\n Correction factor: impurity A, multiply by 0.7.<\/p>\n LIMITS<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.2%;<\/p>\n \u2014 total impurities: not more than 0.5%;<\/p>\n \u2014 reporting threshold: 0.1%.<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions freshly prepared in solution A.<\/p>\n (1) To a weighed amount of the oral solution containing 6 mg of Solifenacin Succinate, add in 30 mL, shake and dilute to produce 50 mL. Dilute 1 volume of this solution to 10 volumes.<\/p>\n (2) 0.0012% w\/v of solifenacin succinate BPCRS.<\/p>\n (3) 0.0012% w\/v of solifenacin succinate BPCRS and 0.00024% w\/v of propyl 4-hydroxybenzoate.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl amorphous organosilica polymer for chromatography (3.5 \u03bcm) (Waters XTerra MS C18 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 a column temperature of 40\u00b0.<\/p>\n (e) Use an autosampler temperature of 5\u00b0.<\/p>\n (f) Use a detection wavelength of 210 nm.<\/p>\n (g) Inject 25 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n 30 volumes of acetonitrile R1 and 70 volumes of a 0.05M ammonium dihydrogen orthophosphate solution previously adjusted to pH 2.4 with orthophosphoric acid.<\/p>\n When the chromatograms are recorded under the prescribed conditions the retention time of the solifenacin is about 11 minutes.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to solifenacin and propyl 4-hydroxybenzoate is at least 1.5.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C_{27<\/sub>H_{32<\/sub>N_{2<\/sub>O_{6<\/sub>, weight in volume, using the declared content of C_{27<\/sub>H_{32<\/sub>N_{2<\/sub>O_{6<\/sub> in solifenacin succinate BPCRS.<\/p>\n}}}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include impurity I listed under Solifenacin Succinate and:<\/p>\n $\"Solifenacin$ <\/p>\n 1. (+)-(R)-quinuclidin-3-yl [2-(2-benzoylphenyl)ethyl]carbamate<\/p>\n","protected":false},"excerpt":{"rendered":" Action and use Muscarinic M3 receptor antagonist; anticholinergic. DEFINITION Solifenacin Oral Solution is a solution of Solifenacin Succinate in a suitable flavoured vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of solifenacin succinate, C27H32N2O6 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay,…<\/p>\n","protected":false},"author":2,"featured_media":21297,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21288","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\/21288","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=21288"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21288\/revisions"}],"predecessor-version":[{"id":21715,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21288\/revisions\/21715"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21297"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21288"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21288"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21288"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}