{"id":20860,"date":"2025-10-27T16:58:23","date_gmt":"2025-10-27T09:58:23","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20860"},"modified":"2025-10-27T16:58:23","modified_gmt":"2025-10-27T09:58:23","slug":"risperidone-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/risperidone-oral-solution\/","title":{"rendered":"Risperidone Oral Solution"},"content":{"rendered":"

Dopamine D_{2<\/sub> receptor antagonist; serotonin 5HT_{2<\/sub> receptor antagonist; neuroleptic.<\/p>\n}}

DEFINITION<\/h2>\n
Risperidone Oral Solution is a solution of Risperidone 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 risperidone, C_{23<\/sub>H_{27<\/sub>FN_{4<\/sub>O_{2<\/sub><\/h3>\n95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\nA. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in methanol.<\/p>\n
(1) Dilute a volume of the oral solution to contain 0.01% w\/v of Risperidone.<\/p>\n
(2) 0.01% w\/v of risperidone BPCRS.<\/p>\n
(3) 0.01% w\/v each of risperidone BPCRS and trazodone hydrochloride BPCRS.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use as the coating silica gel F254.<\/p>\n
(b) Use the mobile phase as described below.<\/p>\n
(c) Apply 20 \u03bcL of each solution.<\/p>\n
(d) Develop the plate to 15 cm.<\/p>\n
(e) After removal of the plate, dry in a current of air and examine under ultraviolet light (254 nm).<\/p>\n
MOBILE PHASE<\/p>\n
3 volumes of glacial acetic acid, 5 volumes of water and 12 volumes of butan-1-ol.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/p>\n
CONFIRMATION<\/p>\n
The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n
B. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Acidity<\/h3>\npH, 2.0 to 4.0, Appendix V L.<\/p>\n
Related substances<\/h3>\nCarry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.<\/p>\n
(1) Dilute a quantity of the oral solution with 0.1M hydrochloric acid, if necessary, to contain 0.01% w\/v of Risperidone.<\/p>\n
(2) Dilute 1 volume of solution (1) to 200 volumes with 0.1M hydrochloric acid.<\/p>\n
(3) Dilute 1 volume of solution (2) to 5 volumes with 0.1M hydrochloric acid.<\/p>\n
(4) 0.005% w\/v of risperidone impurity standard BPCRS in 0.1M hydrochloric acid.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (5 \u03bcm) (Zorbax SB-C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 2.5 mL per minute. Equilibrate the column for at least 30 minutes with methanol at the end of each run.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 275 nm.<\/p>\n
(f) Inject 50 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
Mobile phase A: 0.1 volumes of trifluoroacetic acid, 20 volumes of acetonitrile and 80 volumes of water, adjusting the pH of the mixture to 3.0 with 13.5M ammonia.<\/p>\n
Mobile phase B: 0.1 volumes of trifluoroacetic acid, 39 volumes of methanol and 61 volumes of water, adjusting the pH to 3.0 with 13.5M ammonia.<\/p>\n\n\n\n\n\n\n\n\nTime (Minutes)<\/strong><\/td>\n Mobile phase A (% v\/v)\u00a0<\/strong><\/td>\n Mobile phase B (% v\/v)<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-8<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n
8-16<\/td>\n 100\u21920<\/td>\n 0\u2192100<\/td>\n linear gradient<\/td>\n<\/tr>\n
16-20<\/td>\n 0<\/td>\n 100<\/td>\n isocratic<\/td>\n<\/tr>\n
20-21<\/td>\n 0\u2192100<\/td>\n 100\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
21-30<\/td>\n 100<\/td>\n 0<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nWhen the chromatograms are recorded under the prescribed conditions the retention times relative to risperidone (retention time about 11 minutes) are: impurity B, about 0.6; impurity 2, about 0.7 and impurity 1, about 1.8.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between impurity B and impurity 2 is at least 1.5.<\/p>\n
LIMITS<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity 1 is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n
the area of any peak corresponding to impurity 2 is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n
the area of any other secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n
the sum of the areas of any secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n
ASSAY<\/h2>\nCarry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dilute a quantity of the oral solution with 0.1M hydrochloric acid, if necessary, to contain 0.01% w\/v of Risperidone and filter through a 0.45-\u03bcm filter.<\/p>\n
(2) 0.01% w\/v of risperidone BPCRS in 0.1M hydrochloric acid.<\/p>\n
(3) 0.01% w\/v of risperidone impurity standard BPCRS in 0.1M hydrochloric acid.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (5 \u03bcm) (Zorbax SB-C18 is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 2.5 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 237 nm.<\/p>\n
(f) Inject 50 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
0.1 volumes of trifluoroacetic acid, 20 volumes of acetonitrile and 80 volumes of water adjusting the pH of the mixture to 3.0 with 13.5M ammonia.<\/p>\n
When the chromatograms are recorded under the prescribed conditions the retention times relative to risperidone (retention time about 10 minutes) are: impurity B, about 0.65, impurity 2, about 0.7 and impurity 1, about 1.6.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between impurity 2 and impurity B is at least 1.5.<\/p>\n
DETERMINATION OF CONTENT<\/p>\n
Calculate the total content of risperidone, C_{23<\/sub>H_{27<\/sub>FN_{4<\/sub>O_{2<\/sub>, in the medium from the chromatograms obtained and using the declared content of C_{23<\/sub>H_{27<\/sub>FN_{4<\/sub>O_{2<\/sub> in risperidone BPCRS.<\/p>\n}}}}}}}}
IMPURITIES<\/h2>\nThe impurities limited by the requirements of this monograph include impurity B, listed under Risperidone and the following:<\/p>\n
<\/p>\n
1. cis-4-(6-fluoro-1,2-benzoxazol-3-yl)-1-[2-(2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-3- yl)ethyl]piperidine N-oxide hydrate<\/p>\n
<\/p>\n
2. 3-(4-fluoro-2-hydroxyphenyl)-1-[2-(2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-3-yl)ethyl]-1,2- diazabicyclo[2.2.2]oct-2-en-1-ium iodide<\/p>\n","protected":false},"excerpt":{"rendered":"
Dopamine D2 receptor antagonist; serotonin 5HT2 receptor antagonist; neuroleptic. DEFINITION Risperidone Oral Solution is a solution of Risperidone in a suitable vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of risperidone, C23H27FN4O2 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out the method…<\/p>\n","protected":false},"author":2,"featured_media":20905,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20860","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\/20860","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=20860"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20860\/revisions"}],"predecessor-version":[{"id":20907,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20860\/revisions\/20907"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20905"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}}}}}

Time (Minutes)<\/strong><\/td>\n	Mobile phase A (% v\/v)\u00a0<\/strong><\/td>\n	Mobile phase B (% v\/v)<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-8<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n
8-16<\/td>\n	100\u21920<\/td>\n	0\u2192100<\/td>\n	linear gradient<\/td>\n<\/tr>\n
16-20<\/td>\n	0<\/td>\n	100<\/td>\n	isocratic<\/td>\n<\/tr>\n
20-21<\/td>\n	0\u2192100<\/td>\n	100\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
21-30<\/td>\n	100<\/td>\n	0<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When the chromatograms are recorded under the prescribed conditions the retention times relative to risperidone (retention time about 11 minutes) are: impurity B, about 0.6; impurity 2, about 0.7 and impurity 1, about 1.8.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between impurity B and impurity 2 is at least 1.5.<\/p>\n LIMITS<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity 1 is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n the area of any peak corresponding to impurity 2 is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n the area of any other secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n the sum of the areas of any secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<\/p>\n Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dilute a quantity of the oral solution with 0.1M hydrochloric acid, if necessary, to contain 0.01% w\/v of Risperidone and filter through a 0.45-\u03bcm filter.<\/p>\n (2) 0.01% w\/v of risperidone BPCRS in 0.1M hydrochloric acid.<\/p>\n (3) 0.01% w\/v of risperidone impurity standard BPCRS in 0.1M hydrochloric acid.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (5 \u03bcm) (Zorbax SB-C18 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2.5 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 237 nm.<\/p>\n (f) Inject 50 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n 0.1 volumes of trifluoroacetic acid, 20 volumes of acetonitrile and 80 volumes of water adjusting the pH of the mixture to 3.0 with 13.5M ammonia.<\/p>\n When the chromatograms are recorded under the prescribed conditions the retention times relative to risperidone (retention time about 10 minutes) are: impurity B, about 0.65, impurity 2, about 0.7 and impurity 1, about 1.6.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between impurity 2 and impurity B is at least 1.5.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the total content of risperidone, C_{23<\/sub>H_{27<\/sub>FN_{4<\/sub>O_{2<\/sub>, in the medium from the chromatograms obtained and using the declared content of C_{23<\/sub>H_{27<\/sub>FN_{4<\/sub>O_{2<\/sub> in risperidone BPCRS.<\/p>\n}}}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include impurity B, listed under Risperidone and the following:<\/p>\n $\"Risperidone$ <\/p>\n 1. cis-4-(6-fluoro-1,2-benzoxazol-3-yl)-1-[2-(2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-3- yl)ethyl]piperidine N-oxide hydrate<\/p>\n $\"Risperidone$ <\/p>\n 2. 3-(4-fluoro-2-hydroxyphenyl)-1-[2-(2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-3-yl)ethyl]-1,2- diazabicyclo[2.2.2]oct-2-en-1-ium iodide<\/p>\n","protected":false},"excerpt":{"rendered":" Dopamine D2 receptor antagonist; serotonin 5HT2 receptor antagonist; neuroleptic. DEFINITION Risperidone Oral Solution is a solution of Risperidone in a suitable vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of risperidone, C23H27FN4O2 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out the method…<\/p>\n","protected":false},"author":2,"featured_media":20905,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20860","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\/20860","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=20860"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20860\/revisions"}],"predecessor-version":[{"id":20907,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20860\/revisions\/20907"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20905"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

DEFINITION<\/h2>\nRisperidone Oral Solution is a solution of Risperidone in a suitable vehicle.<\/p>\nThe oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n

TESTS<\/h2>\n

Acidity<\/h3>\npH, 2.0 to 4.0, Appendix V L.<\/p>\n

DEFINITION<\/h2>\n
Risperidone Oral Solution is a solution of Risperidone in a suitable vehicle.<\/p>\n
The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n

Acidity<\/h3>\n
pH, 2.0 to 4.0, Appendix V L.<\/p>\n