{"id":19308,"date":"2025-10-24T17:03:52","date_gmt":"2025-10-24T10:03:52","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19308"},"modified":"2025-10-24T17:03:52","modified_gmt":"2025-10-24T10:03:52","slug":"oxycodone-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/oxycodone-oral-solution\/","title":{"rendered":"Oxycodone Oral Solution"},"content":{"rendered":"

Oxycodone Hydrochloride Oral Solution<\/p>\n

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

Opioid receptor agonist; analgesic.<\/p>\n

DEFINITION<\/h2>\n
Oxycodone Oral Solution contains Oxycodone 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 oxycodone hydrochloride, C_{18<\/sub>H_{21<\/sub>NO_{4<\/sub>, HCl<\/strong><\/p>\n}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n
(1) Adjust the pH of a quantity of the oral solution containing 15 mg of Oxycodone Hydrochloride to pH 9.5 with 6M ammonia. Transfer the solution to a separating funnel and extract with two 5-mL quantities of dichloromethane. Combine the dichloromethane extracts and evaporate 2 mL of the extract to dryness. Dissolve the residue obtained in 1 mL of dichloromethane.<\/p>\n
(2) Transfer 15 mL of a 0.1% w\/v solution of oxycodone hydrochloride BPCRS, adjusted to pH 9.5 with 6M ammonia, to a separating funnel and extract with two 5-mL quantities of dichloromethane. Combine the dichloromethane extracts and evaporate 2 mL of the extract to dryness. Dissolve the residue obtained in 1 mL of dichloromethane.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use as the coating substance silica gel F_{254<\/sub> (Merck TLC silica gel 60 F_{254<\/sub> plates are suitable).<\/p>\n}}
(b) Use the mobile phase described below.<\/p>\n
(c) Apply 20 \u03bcL of each solution.<\/p>\n
(d) Develop the plate to 15 cm.<\/p>\n
(e) Dry the plate in air and examine under ultraviolet light (254 nm).<\/p>\n
MOBILE PHASE<\/h4>\n
3 volumes of 13.5M ammonia, 10 volumes of diethyl ether, 40 volumes of toluene and 60 volumes of acetone.<\/p>\n
CONFIRMATION<\/h4>\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 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
TESTS<\/h2>\n
Acidity<\/h3>\n
pH, 2.5 to 3.0, Appendix V L.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 0.02M acetic acid.<\/p>\n
(1) Shake, with the aid of ultrasound, a quantity of the oral solution containing 20 mg of Oxycodone Hydrochloride with 40 mL of 0.02M acetic acid, add sufficient 0.02M acetic acid to produce 50 mL and filter.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n
(3) Dilute 2 volumes of solution (2) to 10 volumes.<\/p>\n
(4) 0.0002% w\/v of oxycodone impurity standard BPCRS.<\/p>\n
(5) Dilute 1 volume of solution (3) to 4 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm x 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Kromasil C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.5 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/p>\n
(e) Use a detection wavelength of 230 nm.<\/p>\n
(f) Inject 100 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A: 70 volumes of acetonitrile, 100 volumes of methanol and 830 volumes of a 0.11% w\/v solution of sodium heptanesulfonate monohydrate previously adjusted to pH 2.0 with 8M orthophosphoric acid.<\/p>\n
Mobile phase B: 150 volumes of acetonitrile, 250 volumes of methanol and 600 volumes of a 0.11% w\/v solution of sodium heptanesulfonate monohydrate previously adjusted to pH 2.0 with 8M orthophosphoric acid.<\/p>\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
0-60<\/td>\n 100\u219250<\/td>\n 0\u219250<\/td>\n linear gradient<\/td>\n<\/tr>\n
60-62<\/td>\n 50\u2192100<\/td>\n 50\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
62-70<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatograms are recorded using the prescribed conditions, the retention time of oxycodone is about 24 minutes. The retention times relative to oxycodone are: impurity D, about 1.18; impurity E, about 1.18 and impurity F, about 2.4.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 3.0.<\/p>\n
LIMITS<\/h4>\n
Identify any peaks in the chromatogram obtained with solution (1) corresponding to thebaine and multiply the area of this peak by 0.5.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the sum of the areas of any peaks corresponding to 14-hydroxycodeinone and hydrocodone is not greater than the area of<\/p>\n
the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n
the area of any other secondary peak is not greater than 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 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%).<\/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 in 0.02M acetic acid.<\/p>\n
(1) To a quantity of the oral solution containing 25 mg of Oxycodone Hydrochloride add sufficient 0.02M acetic acid to produce 50 mL and filter.Dilute 1 volume of this solution to 100 volumes with 0.02M acetic acid.<\/p>\n
(2) 0.0005% w\/v of oxycodone hydrochloride BPCRS.<\/p>\n
(3) 0.0002% w\/v of oxycodone impurity standard BPCRS.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm x 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Kromasil C18 is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.5 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/p>\n
(e) Use a detection wavelength of 230 nm.<\/p>\n
(f) Inject 100 \u03bcL of each solution.<\/p>\n
(g) For solution (3) allow the chromatography to proceed for 4 times the retention time of the peak due to oxycodone.<\/p>\n
MOBILE PHASE<\/h4>\n
100 volumes of acetonitrile, 200 volumes of methanol and 700 volumes of a solution containing 0.11% w\/v of sodium heptanesulfonate monohydrate previously adjusted to pH 2.0 with 8M orthophosphoric acid.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 2.0.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of oxycodone hydrochloride, C_{18<\/sub>H_{21<\/sub>NO_{4<\/sub>, HCl, in the oral solution from the chromatograms obtained and using the declared content of C_{18<\/sub>H_{21<\/sub>NO_{4<\/sub>, HCl\u00a0in oxycodone hydrochloride BPCRS.<\/p>\n}}}}}}
IMPURITIES<\/h2>\n
D. 7,8-didehydro-4,5\u03b1-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one (14-hydroxycodeinone);<\/p>\n
E. 4,5\u03b1-epoxy-3-methoxy-17-methylmorphinan-6-one (hydrocodone);<\/p>\n
F. 6,7,8,14-tetradehydro-4,5\u03b1-epoxy-3-6-dimethoxy-17-methylmorphinan (thebaine).<\/p>\n","protected":false},"excerpt":{"rendered":"
Oxycodone Hydrochloride Oral Solution Action and use Opioid receptor agonist; analgesic. DEFINITION Oxycodone Oral Solution contains Oxycodone Hydrochloride in a suitable vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of oxycodone hydrochloride, C18H21NO4, HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out…<\/p>\n","protected":false},"author":4,"featured_media":19325,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19308","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\/19308","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=19308"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19308\/revisions"}],"predecessor-version":[{"id":19329,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19308\/revisions\/19329"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19325"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19308"}],"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
0-60<\/td>\n	100\u219250<\/td>\n	0\u219250<\/td>\n	linear gradient<\/td>\n<\/tr>\n
60-62<\/td>\n	50\u2192100<\/td>\n	50\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
62-70<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When the chromatograms are recorded using the prescribed conditions, the retention time of oxycodone is about 24 minutes. The retention times relative to oxycodone are: impurity D, about 1.18; impurity E, about 1.18 and impurity F, about 2.4.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 3.0.<\/p>\n LIMITS<\/h4>\n Identify any peaks in the chromatogram obtained with solution (1) corresponding to thebaine and multiply the area of this peak by 0.5.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the sum of the areas of any peaks corresponding to 14-hydroxycodeinone and hydrocodone is not greater than the area of<\/p>\n the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n the area of any other secondary peak is not greater than 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 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%).<\/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 in 0.02M acetic acid.<\/p>\n (1) To a quantity of the oral solution containing 25 mg of Oxycodone Hydrochloride add sufficient 0.02M acetic acid to produce 50 mL and filter.Dilute 1 volume of this solution to 100 volumes with 0.02M acetic acid.<\/p>\n (2) 0.0005% w\/v of oxycodone hydrochloride BPCRS.<\/p>\n (3) 0.0002% w\/v of oxycodone impurity standard BPCRS.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h4>\n (a) Use a stainless steel column (15 cm x 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Kromasil C18 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.5 mL per minute.<\/p>\n (d) Use a column temperature of 40\u00b0.<\/p>\n (e) Use a detection wavelength of 230 nm.<\/p>\n (f) Inject 100 \u03bcL of each solution.<\/p>\n (g) For solution (3) allow the chromatography to proceed for 4 times the retention time of the peak due to oxycodone.<\/p>\n MOBILE PHASE<\/h4>\n 100 volumes of acetonitrile, 200 volumes of methanol and 700 volumes of a solution containing 0.11% w\/v of sodium heptanesulfonate monohydrate previously adjusted to pH 2.0 with 8M orthophosphoric acid.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 2.0.<\/p>\n DETERMINATION OF CONTENT<\/h4>\n Calculate the total content of oxycodone hydrochloride, C_{18<\/sub>H_{21<\/sub>NO_{4<\/sub>, HCl, in the oral solution from the chromatograms obtained and using the declared content of C_{18<\/sub>H_{21<\/sub>NO_{4<\/sub>, HCl\u00a0in oxycodone hydrochloride BPCRS.<\/p>\n}}}}}} IMPURITIES<\/h2>\n D. 7,8-didehydro-4,5\u03b1-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one (14-hydroxycodeinone);<\/p>\n E. 4,5\u03b1-epoxy-3-methoxy-17-methylmorphinan-6-one (hydrocodone);<\/p>\n F. 6,7,8,14-tetradehydro-4,5\u03b1-epoxy-3-6-dimethoxy-17-methylmorphinan (thebaine).<\/p>\n","protected":false},"excerpt":{"rendered":" Oxycodone Hydrochloride Oral Solution Action and use Opioid receptor agonist; analgesic. DEFINITION Oxycodone Oral Solution contains Oxycodone Hydrochloride in a suitable vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of oxycodone hydrochloride, C18H21NO4, HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out…<\/p>\n","protected":false},"author":4,"featured_media":19325,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19308","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\/19308","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=19308"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19308\/revisions"}],"predecessor-version":[{"id":19329,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19308\/revisions\/19329"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19325"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

MOBILE PHASE<\/h4>\n3 volumes of 13.5M ammonia, 10 volumes of diethyl ether, 40 volumes of toluene and 60 volumes of acetone.<\/p>\n

TESTS<\/h2>\n

Acidity<\/h3>\npH, 2.5 to 3.0, Appendix V L.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 3.0.<\/p>\n

MOBILE PHASE<\/h4>\n100 volumes of acetonitrile, 200 volumes of methanol and 700 volumes of a solution containing 0.11% w\/v of sodium heptanesulfonate monohydrate previously adjusted to pH 2.0 with 8M orthophosphoric acid.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 2.0.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the total content of oxycodone hydrochloride, C18<\/sub>H21<\/sub>NO4<\/sub>, HCl, in the oral solution from the chromatograms obtained and using the declared content of C18<\/sub>H21<\/sub>NO4<\/sub>, HCl\u00a0in oxycodone hydrochloride BPCRS.<\/p>\n

MOBILE PHASE<\/h4>\n
3 volumes of 13.5M ammonia, 10 volumes of diethyl ether, 40 volumes of toluene and 60 volumes of acetone.<\/p>\n

Acidity<\/h3>\n
pH, 2.5 to 3.0, Appendix V L.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 3.0.<\/p>\n

MOBILE PHASE<\/h4>\n
100 volumes of acetonitrile, 200 volumes of methanol and 700 volumes of a solution containing 0.11% w\/v of sodium heptanesulfonate monohydrate previously adjusted to pH 2.0 with 8M orthophosphoric acid.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the peaks due to oxycodone and 14-hydroxycodeinone is at least 2.0.<\/p>\n