{"id":19248,"date":"2025-10-24T16:23:35","date_gmt":"2025-10-24T09:23:35","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19248"},"modified":"2025-10-24T16:28:05","modified_gmt":"2025-10-24T09:28:05","slug":"oxybutynin-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/oxybutynin-oral-solution\/","title":{"rendered":"Oxybutynin Oral Solution"},"content":{"rendered":"

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

Anticholinergic.<\/p>\n

DEFINITION<\/h2>\n
Oxybutynin Oral Solution contains Oxybutynin Hydrochloride in a suitable vehicle.<\/p>\n
The oral solution complies with the requirements stated under Oral Liquids and with the following requirements<\/p>\n
Content of oxybutynin hydrochloride, C_{22<\/sub>H_{31<\/sub>NO_{3<\/sub>, HCl<\/strong><\/p>\n}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
To a quantity of the oral solution containing 25 mg of Oxybutynin Hydrochloride add sufficient 2M sodium hydroxide to adjust to pH 12.0 and extract with four 20-mL quantities of\u00a0 hexane. Filter the collected hexane layers through anhydrous sodium sulfate (Whatman GF\/C is suitable). Evaporate the filtrate to dryness under a current of nitrogen, to yield a clear, sticky liquid residue. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of oxybutynin (RS 442).<\/p>\n
TESTS<\/h2>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Mix a quantity of the oral solution containing 25 mg of Oxybutynin Hydrochloride with 40 mL of 0.01M hydrochloric acid, add sufficient 0.01M hydrochloric acid to produce 100 mL, mix and filter.<\/p>\n
(2) 0.000375% w\/v of oxybutynin impurity A EPCRS in 0.01M hydrochloric acid.<\/p>\n
(3) 0.00025% w\/v of phenylcyclohexylglycolic acid BPCRS in 0.01M hydrochloric acid.<\/p>\n
(4) Dilute 1 volume of solution (1) to 200 volumes with 0.01M hydrochloric acid.<\/p>\n
(5) 0.0000125% w\/v of oxybutynin impurity A EPCRS in solution (4).<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography R1 (5 \u03bcm) (Symmetry C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phases 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 210 nm.<\/p>\n
(f) Inject 50 \u03bcL of each solution.<\/p>\n
(g) When the chromatograms are recorded under the prescribed conditions the retention times are about 31 minutes for oxybutynin hydrochloride and about 47 minutes for oxybutynin impurity A.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A 0.34% w\/v of potassium dihydrogen orthophosphate and 0.436% w\/v of dipotassium hydrogen orthophosphate.<\/p>\n
Mobile phase B acetonitrile R1.<\/p>\n\n\n\n\n\n\n\n\n
Time (Minutes)\u00a0<\/strong><\/td>\n Mobile phase A (% v\/v)\u00a0<\/strong><\/td>\n Mobile phase B (% v\/v)\u00a0<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-5<\/td>\n 70<\/td>\n 30<\/td>\n isocratic<\/td>\n<\/tr>\n
5-6<\/td>\n 70\u219245<\/td>\n 30\u219255<\/td>\n linear gradient<\/td>\n<\/tr>\n
6-50<\/td>\n 45<\/td>\n 55<\/td>\n isocratic<\/td>\n<\/tr>\n
50-51<\/td>\n 45\u219270<\/td>\n 55\u219230<\/td>\n linear gradient<\/td>\n<\/tr>\n
51-60<\/td>\n 70<\/td>\n 30<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between the peaks due to oxybutynin hydrochloride and oxybutynin impurity A is at least 10.0.<\/p>\n
LIMITS<\/h4>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to oxybutynin impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.5%);<\/p>\n
the area of any peak corresponding to phenylcyclohexylglycolic acid is not greater than half the area of the principal peak in the chromatogram obtained with solution (3) (0.5%);<\/p>\n
the area of any other secondary peak is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (4) (0.2%);<\/p>\n
the sum of the areas of any such secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.5%).<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (5) (0.05%).<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Mix a quantity of the oral solution containing 25 mg of Oxybutynin Hydrochloride with 400 mL of 0.01M hydrochloric acid, add sufficient 0.01M hydrochloric acid to produce 500 mL, mix and filter.<\/p>\n
(2) 0.005% w\/v of oxybutynin hydrochloride BPCRS in 0.01M hydrochloric acid.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with nitrile silica gel for chromatography R1 (5 \u03bcm) (Spherisorb CN is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 2 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/p>\n
(e) Use a detection wavelength of 200 nm.<\/p>\n
(f) Inject 20 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
300 volumes of acetonitrile R1 and 700 volumes of a 0.48% w\/v solution of anhydrous potassium dihydrogen orthophosphate previously adjusted to pH 3.0 to 3.5 with orthophosphoric acid.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of C_{22<\/sub>H_{31<\/sub>NO_{3<\/sub>, HCl in the oral slution using the declared content of C_{22<\/sub>H_{31<\/sub>NO_{3<\/sub>, HCl in oxybutynin hydrochloride BPCRS.<\/p>\n}}}}}}
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include:<\/p>\n
$\"Oxybutynin$ <\/p>\n
1. 4-(diethylamino)but-2-ynyl (RS)-2-(cyclohex-3-enyl)-2-cyclohexyl-2-hydroxyacetate (European Pharmacopoeia impurity A),<\/p>\n
$\"Oxybutynin$ <\/p>\n
2. (RS)-2-cyclohexyl-2-hydroxy-2-phenylacetic acid (phenylcyclohexylglycolic acid) (European Pharmacopoeia impurity D)<\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
Action and use Anticholinergic. DEFINITION Oxybutynin Oral Solution contains Oxybutynin Hydrochloride in a suitable vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements Content of oxybutynin hydrochloride, C22H31NO3, HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION To a quantity of the oral solution containing 25 mg…<\/p>\n","protected":false},"author":4,"featured_media":19257,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19248","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\/19248","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=19248"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19248\/revisions"}],"predecessor-version":[{"id":19263,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19248\/revisions\/19263"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19257"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19248"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19248"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19248"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)\u00a0<\/strong><\/td>\n	Mobile phase A (% v\/v)\u00a0<\/strong><\/td>\n	Mobile phase B (% v\/v)\u00a0<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-5<\/td>\n	70<\/td>\n	30<\/td>\n	isocratic<\/td>\n<\/tr>\n
5-6<\/td>\n	70\u219245<\/td>\n	30\u219255<\/td>\n	linear gradient<\/td>\n<\/tr>\n
6-50<\/td>\n	45<\/td>\n	55<\/td>\n	isocratic<\/td>\n<\/tr>\n
50-51<\/td>\n	45\u219270<\/td>\n	55\u219230<\/td>\n	linear gradient<\/td>\n<\/tr>\n
51-60<\/td>\n	70<\/td>\n	30<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between the peaks due to oxybutynin hydrochloride and oxybutynin impurity A is at least 10.0.<\/p>\n LIMITS<\/h4>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to oxybutynin impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.5%);<\/p>\n the area of any peak corresponding to phenylcyclohexylglycolic acid is not greater than half the area of the principal peak in the chromatogram obtained with solution (3) (0.5%);<\/p>\n the area of any other secondary peak is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (4) (0.2%);<\/p>\n the sum of the areas of any such secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.5%).<\/p>\n Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (5) (0.05%).<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Mix a quantity of the oral solution containing 25 mg of Oxybutynin Hydrochloride with 400 mL of 0.01M hydrochloric acid, add sufficient 0.01M hydrochloric acid to produce 500 mL, mix and filter.<\/p>\n (2) 0.005% w\/v of oxybutynin hydrochloride BPCRS in 0.01M hydrochloric acid.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h4>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with nitrile silica gel for chromatography R1 (5 \u03bcm) (Spherisorb CN is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2 mL per minute.<\/p>\n (d) Use a column temperature of 40\u00b0.<\/p>\n (e) Use a detection wavelength of 200 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/h4>\n 300 volumes of acetonitrile R1 and 700 volumes of a 0.48% w\/v solution of anhydrous potassium dihydrogen orthophosphate previously adjusted to pH 3.0 to 3.5 with orthophosphoric acid.<\/p>\n DETERMINATION OF CONTENT<\/h4>\n Calculate the content of C_{22<\/sub>H_{31<\/sub>NO_{3<\/sub>, HCl in the oral slution using the declared content of C_{22<\/sub>H_{31<\/sub>NO_{3<\/sub>, HCl in oxybutynin hydrochloride BPCRS.<\/p>\n}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include:<\/p>\n $\"Oxybutynin$ <\/p>\n 1. 4-(diethylamino)but-2-ynyl (RS)-2-(cyclohex-3-enyl)-2-cyclohexyl-2-hydroxyacetate (European Pharmacopoeia impurity A),<\/p>\n $\"Oxybutynin$ <\/p>\n 2. (RS)-2-cyclohexyl-2-hydroxy-2-phenylacetic acid (phenylcyclohexylglycolic acid) (European Pharmacopoeia impurity D)<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" Action and use Anticholinergic. DEFINITION Oxybutynin Oral Solution contains Oxybutynin Hydrochloride in a suitable vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements Content of oxybutynin hydrochloride, C22H31NO3, HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION To a quantity of the oral solution containing 25 mg…<\/p>\n","protected":false},"author":4,"featured_media":19257,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19248","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\/19248","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=19248"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19248\/revisions"}],"predecessor-version":[{"id":19263,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19248\/revisions\/19263"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19257"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19248"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19248"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19248"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between the peaks due to oxybutynin hydrochloride and oxybutynin impurity A is at least 10.0.<\/p>\n

MOBILE PHASE<\/h4>\n300 volumes of acetonitrile R1 and 700 volumes of a 0.48% w\/v solution of anhydrous potassium dihydrogen orthophosphate previously adjusted to pH 3.0 to 3.5 with orthophosphoric acid.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the content of C22<\/sub>H31<\/sub>NO3<\/sub>, HCl in the oral slution using the declared content of C22<\/sub>H31<\/sub>NO3<\/sub>, HCl in oxybutynin hydrochloride BPCRS.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between the peaks due to oxybutynin hydrochloride and oxybutynin impurity A is at least 10.0.<\/p>\n

MOBILE PHASE<\/h4>\n
300 volumes of acetonitrile R1 and 700 volumes of a 0.48% w\/v solution of anhydrous potassium dihydrogen orthophosphate previously adjusted to pH 3.0 to 3.5 with orthophosphoric acid.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of C_{22<\/sub>H_{31<\/sub>NO_{3<\/sub>, HCl in the oral slution using the declared content of C_{22<\/sub>H_{31<\/sub>NO_{3<\/sub>, HCl in oxybutynin hydrochloride BPCRS.<\/p>\n}}}}}}