{"id":19796,"date":"2025-10-25T14:46:26","date_gmt":"2025-10-25T07:46:26","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19796"},"modified":"2025-10-25T14:46:26","modified_gmt":"2025-10-25T07:46:26","slug":"paracetamol-soluble-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/paracetamol-soluble-tablets\/","title":{"rendered":"Paracetamol Soluble Tablets"},"content":{"rendered":"

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

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

Analgesic; antipyretic.<\/p>\n

DEFINITION<\/h2>\n
Paracetamol Soluble Tablets contain Paracetamol in a suitable soluble basis.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n
Content of paracetamol, C_{8<\/sub>H_{9<\/sub>NO_{2<\/sub><\/strong><\/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<\/strong><\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Protect the solutions from light.<\/p>\n
Solution A 15 volumes of methanol and 85 volumes of water.<\/p>\n
(1) Disperse a quantity of powdered tablets containing 0.2 g of Paracetamol in 20 mL of solution A with the aid of ultrasound, add sufficient solution A to produce 25 mL, mix and filter (0.45 \u00b5m nylon filter is suitable). Prepare immediately before use.<\/p>\n
(2) Dilute 1 volume of solution (1) to 20 volumes with solution A and dilute 1 volume of the resulting solution to 50 volumes with solution A.<\/p>\n
(3) 0.00008% w\/v of 4-aminophenol (paracetamol impurity K) in solution A. Prepare immediately before use.<\/p>\n
(4) 0.02% w\/v solution of 4\u2032-chloroacetanilide (paracetamol impurity J) in methanol, diluted in solution A to produce a solution containing 0.000008% w\/v of 4\u2032-chloroacetanilide.<\/p>\n
(5) Mix equal volumes of solution (2) and solution (3).<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped solid core octadecylsilyl silica gel for chromatography (5 \u00b5m) (Halo 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 30\u00b0.<\/p>\n
(e) Use an autosampler at 5\u00b0.<\/p>\n
(f) Use a detection wavelength of 254 nm.<\/p>\n
(g) Inject 50 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
Mobile phase A<\/em> Dissolve 1.7 g of potassium dihydrogen phosphate and 1.8 g of dipotassium hydrogen phosphate in water and dilute to 1000 mL with water.<\/p>\n
Mobile phase B<\/em> Methanol.<\/p>\n\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
0-1.5<\/td>\n 95<\/td>\n 5<\/td>\n isocratic<\/td>\n<\/tr>\n
1.5-14.5<\/td>\n 95\u219290<\/td>\n 5\u219210<\/td>\n linear gradient<\/td>\n<\/tr>\n
14.5-29<\/td>\n 90<\/td>\n 10<\/td>\n isocratic<\/td>\n<\/tr>\n
29-58<\/td>\n 90\u219266<\/td>\n 10\u219234<\/td>\n linear gradient<\/td>\n<\/tr>\n
58-60<\/td>\n 66<\/td>\n 34<\/td>\n isocratic<\/td>\n<\/tr>\n
60-65<\/td>\n 66\u219295<\/td>\n 34\u21925<\/td>\n linear gradient<\/td>\n<\/tr>\n
65-70<\/td>\n 95<\/td>\n 5<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (5), the resolution between the peaks due to paracetamol impurity K and paracetamol is at least 5.0.<\/p>\n
CALCULATION OF IMPURITIES<\/h3>\n
For impurity K, use the concentration in solution (3). For impurity J, use the concentration in solution (4).<\/p>\n
For any other impurity, use the concentration of paracetamol in solution (2).<\/p>\n
For the reporting threshold, use the concentration of paracetamol in solution (2). Paracetamol retention time: about 4 minutes.<\/p>\n
Relative retention: impurity K, about 0.4; impurity J, about 10.0.<\/p>\n
LIMITS<\/h3>\n
\u2014 impurity K: not more than 100 ppm;<\/p>\n
\u2014 impurity J: not more than 10 ppm;<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 0.10%;<\/p>\n
\u2014 total impurities: not more than 0.5%;<\/p>\n
\u2014 reporting threshold: 0.05%.<\/p>\n
ASSAY<\/h2>\n
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Protect the solutions from light.<\/p>\n
(1) Disperse a quantity of the powdered tablets containing 0.5 g of Paracetamol in 80 mL of the mobile phase with the aid of ultrasound, add sufficient mobile phase to produce 100 mL, mix well, filter and dilute 1 volume of the resulting solution to 100 volumes with the mobile phase.<\/p>\n
(2) 0.005% w\/v of paracetamol BPCRS in the mobile phase.<\/p>\n
(3) 0.002% w\/v each of 4-aminophenol and paracetamol BPCRS in the mobile phase.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with base-deactivated octylsilyl silica gel for chromatography (5 \u00b5m) (Zorbax Rx C8 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 35\u00b0.<\/p>\n
(e) Use a detection wavelength of 245 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
250 volumes of methanol containing 1.15 g of a 40% w\/v solution of tetrabutylammonium hydroxide, 375 volumes of 0.05M disodium hydrogen orthophosphate and 375 volumes of 0.05M sodium dihydrogen orthophosphate.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 4.0.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{8<\/sub>H_{9<\/sub>NO_{2<\/sub> in the tablets, using the declared content of C_{8<\/sub>H_{9<\/sub>NO_{2<\/sub> in paracetamol BPCRS.<\/p>\n}}}}}}
STORAGE<\/h2>\n
Paracetamol Soluble Tablets should be protected from light and moisture.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include impurities J and K listed under Paracetamol.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Analgesic; antipyretic. DEFINITION Paracetamol Soluble Tablets contain Paracetamol in a suitable soluble basis. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of paracetamol, C8H9NO2 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV…<\/p>\n","protected":false},"author":5,"featured_media":19800,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19796","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\/19796","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=19796"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19796\/revisions"}],"predecessor-version":[{"id":19816,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19796\/revisions\/19816"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19800"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19796"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19796"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19796"}],"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
0-1.5<\/td>\n	95<\/td>\n	5<\/td>\n	isocratic<\/td>\n<\/tr>\n
1.5-14.5<\/td>\n	95\u219290<\/td>\n	5\u219210<\/td>\n	linear gradient<\/td>\n<\/tr>\n
14.5-29<\/td>\n	90<\/td>\n	10<\/td>\n	isocratic<\/td>\n<\/tr>\n
29-58<\/td>\n	90\u219266<\/td>\n	10\u219234<\/td>\n	linear gradient<\/td>\n<\/tr>\n
58-60<\/td>\n	66<\/td>\n	34<\/td>\n	isocratic<\/td>\n<\/tr>\n
60-65<\/td>\n	66\u219295<\/td>\n	34\u21925<\/td>\n	linear gradient<\/td>\n<\/tr>\n
65-70<\/td>\n	95<\/td>\n	5<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless, in the chromatogram obtained with solution (5), the resolution between the peaks due to paracetamol impurity K and paracetamol is at least 5.0.<\/p>\n CALCULATION OF IMPURITIES<\/h3>\n For impurity K, use the concentration in solution (3). For impurity J, use the concentration in solution (4).<\/p>\n For any other impurity, use the concentration of paracetamol in solution (2).<\/p>\n For the reporting threshold, use the concentration of paracetamol in solution (2). Paracetamol retention time: about 4 minutes.<\/p>\n Relative retention: impurity K, about 0.4; impurity J, about 10.0.<\/p>\n LIMITS<\/h3>\n \u2014 impurity K: not more than 100 ppm;<\/p>\n \u2014 impurity J: not more than 10 ppm;<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.10%;<\/p>\n \u2014 total impurities: not more than 0.5%;<\/p>\n \u2014 reporting threshold: 0.05%.<\/p>\n ASSAY<\/h2>\n Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Protect the solutions from light.<\/p>\n (1) Disperse a quantity of the powdered tablets containing 0.5 g of Paracetamol in 80 mL of the mobile phase with the aid of ultrasound, add sufficient mobile phase to produce 100 mL, mix well, filter and dilute 1 volume of the resulting solution to 100 volumes with the mobile phase.<\/p>\n (2) 0.005% w\/v of paracetamol BPCRS in the mobile phase.<\/p>\n (3) 0.002% w\/v each of 4-aminophenol and paracetamol BPCRS in the mobile phase.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h3>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with base-deactivated octylsilyl silica gel for chromatography (5 \u00b5m) (Zorbax Rx C8 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 35\u00b0.<\/p>\n (e) Use a detection wavelength of 245 nm.<\/p>\n (f) Inject 20 \u00b5L of each solution.<\/p>\n MOBILE PHASE<\/h3>\n 250 volumes of methanol containing 1.15 g of a 40% w\/v solution of tetrabutylammonium hydroxide, 375 volumes of 0.05M disodium hydrogen orthophosphate and 375 volumes of 0.05M sodium dihydrogen orthophosphate.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 4.0.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Calculate the content of C_{8<\/sub>H_{9<\/sub>NO_{2<\/sub> in the tablets, using the declared content of C_{8<\/sub>H_{9<\/sub>NO_{2<\/sub> in paracetamol BPCRS.<\/p>\n}}}}}} STORAGE<\/h2>\n Paracetamol Soluble Tablets should be protected from light and moisture.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include impurities J and K listed under Paracetamol.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Analgesic; antipyretic. DEFINITION Paracetamol Soluble Tablets contain Paracetamol in a suitable soluble basis. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of paracetamol, C8H9NO2 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV…<\/p>\n","protected":false},"author":5,"featured_media":19800,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19796","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\/19796","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=19796"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19796\/revisions"}],"predecessor-version":[{"id":19816,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19796\/revisions\/19816"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19800"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19796"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19796"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19796"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless, in the chromatogram obtained with solution (5), the resolution between the peaks due to paracetamol impurity K and paracetamol is at least 5.0.<\/p>\n

LIMITS<\/h3>\n\u2014 impurity K: not more than 100 ppm;<\/p>\n\u2014 impurity J: not more than 10 ppm;<\/p>\n\u2014 unspecified impurities: for each impurity, not more than 0.10%;<\/p>\n\u2014 total impurities: not more than 0.5%;<\/p>\n\u2014 reporting threshold: 0.05%.<\/p>\n

MOBILE PHASE<\/h3>\n250 volumes of methanol containing 1.15 g of a 40% w\/v solution of tetrabutylammonium hydroxide, 375 volumes of 0.05M disodium hydrogen orthophosphate and 375 volumes of 0.05M sodium dihydrogen orthophosphate.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 4.0.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of C8<\/sub>H9<\/sub>NO2<\/sub> in the tablets, using the declared content of C8<\/sub>H9<\/sub>NO2<\/sub> in paracetamol BPCRS.<\/p>\n

STORAGE<\/h2>\nParacetamol Soluble Tablets should be protected from light and moisture.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (5), the resolution between the peaks due to paracetamol impurity K and paracetamol is at least 5.0.<\/p>\n

LIMITS<\/h3>\n
\u2014 impurity K: not more than 100 ppm;<\/p>\n
\u2014 impurity J: not more than 10 ppm;<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 0.10%;<\/p>\n
\u2014 total impurities: not more than 0.5%;<\/p>\n
\u2014 reporting threshold: 0.05%.<\/p>\n

MOBILE PHASE<\/h3>\n
250 volumes of methanol containing 1.15 g of a 40% w\/v solution of tetrabutylammonium hydroxide, 375 volumes of 0.05M disodium hydrogen orthophosphate and 375 volumes of 0.05M sodium dihydrogen orthophosphate.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 4.0.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{8<\/sub>H_{9<\/sub>NO_{2<\/sub> in the tablets, using the declared content of C_{8<\/sub>H_{9<\/sub>NO_{2<\/sub> in paracetamol BPCRS.<\/p>\n}}}}}}

STORAGE<\/h2>\n
Paracetamol Soluble Tablets should be protected from light and moisture.<\/p>\n