{"id":7218,"date":"2025-10-01T16:15:10","date_gmt":"2025-10-01T09:15:10","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=7218"},"modified":"2025-10-01T16:15:10","modified_gmt":"2025-10-01T09:15:10","slug":"capecitabine-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/capecitabine-tablets\/","title":{"rendered":"Capecitabine Tablets"},"content":{"rendered":"

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

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

Pyrimidine analogue; cytotoxic; treatment of cancer.<\/p>\n

DEFINITION<\/h2>\n
Capecitabine Tablets contain Capecitabine.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n
Content of capecitabine, C_{15<\/sub>H_{22<\/sub>FN_{3<\/sub>O_{6<\/sub><\/strong><\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
Shake a quantity of the powdered tablets containing 0.05 g of Capecitabine with 4 mL of ethanol and filter. Evaporate the filtrate to dryness, under a stream of nitrogen, on a water bath at 65\u00b0. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of capecitabine BPCRS treated in the same manner.<\/p>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
Carry out the following procedure protected from light. Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n
TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n
(b) Use 900 mL of phosphate buffer pH 6.8, at a temperature of 37\u00b0, as the medium.<\/p>\n
PROCEDURE<\/h4>\n
(1) After 30 minutes withdraw a sample of the dissolution medium and filter. Use the filtered medium, diluted with phosphate buffer pH 6.8, if necessary, to produce a solution expected to contain 0.017% w\/v of Capecitabine.<\/p>\n
(2) 0.017% w\/v of capecitabine BPCRS in phosphate buffer pH 6.8.<\/p>\n
(3) 0.017% w\/v of capecitabine BPCRS and 0.000025% w\/v of capecitabine impurity D EPCRS in phosphate buffer pH 6.8.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u00b5m) (Zorbax Eclipse XDB-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 a detection wavelength of 250 nm.<\/p>\n
(f) Inject 40 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A<\/em> 5 volumes of acetonitrile, 35 volumes of methanol and 60 volumes of a 0.1% v\/v solution of glacial acetic acid.<\/p>\n
Mobile phase B<\/em> 5 volumes of acetonitrile, 80 volumes of methanol and 15 volumes of a 0.1% v\/v solution of glacial acetic acid.<\/p>\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
0-5<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n
5-20<\/td>\n 100\u219249<\/td>\n 0\u219251<\/td>\n linear gradient<\/td>\n<\/tr>\n
20-30<\/td>\n 49<\/td>\n 51<\/td>\n isocratic<\/td>\n<\/tr>\n
30-32<\/td>\n 49\u2192100<\/td>\n 51\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
32-40<\/td>\n 100<\/td>\n 0<\/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 (3), the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of C15H22FN3O6 in the medium using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n
LIMITS<\/h4>\n
The amount of capecitabine released is not less than 75% (Q) of the stated amount.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Prepare the solutions immediately before use.<\/p>\n
Solvent A<\/em> 5 volumes of acetonitrile, 35 volumes of methanol and 60 volumes of water.<\/p>\n
(1) Shake a quantity of powdered tablets containing 60 mg of Capecitabine with 80 mL of solvent A, dilute to 100 mL with the solvent A and filter.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes with solvent A.<\/p>\n
(3) Dilut1 2 volume of solution (2) to 5 volumes with solvent A.<\/p>\n
(4) 0.06% w\/v of capecitabine BPCRS and 0.0001% w\/v each of capecitabine impurity A EPCRS, capecitabine impurity B EPCRS and capecitabine impurity D EPCRS in solvent A.<\/p>\n
The chromatographic conditions described under Dissolution may be used with an injection volume of 10 \u00b5L.<\/p>\n
When chromatograms are recorded under the prescribed conditions, the retention times relative to capecitabine (retention time, about 16 minutes) are: impurity A, about 0.16; impurity B, about 0.18; impurities D and E (co-elute), 0.94.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (4):<\/p>\n
the resolution between the peaks due to impurity A and impurity B is at least 1.5; the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n
LIMITS<\/h4>\n
Identify any peak corresponding to impurity B using the chromatogram obtained with solution (4) and multiply the peak area by the correction factor of 1.3.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak due to impurity A or impurity B is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n
the sum of the areas of any peak due to impurities D and E is not greater than half 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 the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n
the sum of the areas of all secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%).<\/p>\n
Disregard any peak with an area less than 0.25 times the area of the principal peak in the chromatogram obtained with solution (3) (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. Prepare the solutions immediately before use.<\/p>\n
Solvent A<\/em> 5 volumes of acetonitrile, 35 volumes of methanol and 60 volumes of water.<\/p>\n
(1) Shake a quantity of powdered tablets containing 60 mg of Capecitabine with 80 mL of solvent A, dilute to 100 mL with the solvent A and filter.<\/p>\n
(2) 0.06% w\/v of capecitabine BPCRS in solvent A.<\/p>\n
(3) 0.06% w\/v of capecitabine BPCRS and 0.0001% w\/v of capecitabine impurity D EPCRS in solvent A. The chromatographic conditions described under Dissolution may be used with an injection volume of 10 \u00b5L.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C15H22FN3O6 in the tablets using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Capecitabine.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Pyrimidine analogue; cytotoxic; treatment of cancer. DEFINITION Capecitabine Tablets contain Capecitabine. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of capecitabine, C15H22FN3O6 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of the powdered tablets containing…<\/p>\n","protected":false},"author":5,"featured_media":7223,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-7218","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\/7218","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=7218"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/7218\/revisions"}],"predecessor-version":[{"id":7238,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/7218\/revisions\/7238"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/7223"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=7218"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=7218"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=7218"}],"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
0-5<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n
5-20<\/td>\n	100\u219249<\/td>\n	0\u219251<\/td>\n	linear gradient<\/td>\n<\/tr>\n
20-30<\/td>\n	49<\/td>\n	51<\/td>\n	isocratic<\/td>\n<\/tr>\n
30-32<\/td>\n	49\u2192100<\/td>\n	51\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
32-40<\/td>\n	100<\/td>\n	0<\/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 (3), the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n DETERMINATION OF CONTENT<\/h4>\n Calculate the content of C15H22FN3O6 in the medium using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n LIMITS<\/h4>\n The amount of capecitabine released is not less than 75% (Q) of the stated amount.<\/p>\n Related substances<\/h3>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Prepare the solutions immediately before use.<\/p>\n Solvent A<\/em> 5 volumes of acetonitrile, 35 volumes of methanol and 60 volumes of water.<\/p>\n (1) Shake a quantity of powdered tablets containing 60 mg of Capecitabine with 80 mL of solvent A, dilute to 100 mL with the solvent A and filter.<\/p>\n (2) Dilute 1 volume of solution (1) to 100 volumes with solvent A.<\/p>\n (3) Dilut1 2 volume of solution (2) to 5 volumes with solvent A.<\/p>\n (4) 0.06% w\/v of capecitabine BPCRS and 0.0001% w\/v each of capecitabine impurity A EPCRS, capecitabine impurity B EPCRS and capecitabine impurity D EPCRS in solvent A.<\/p>\n The chromatographic conditions described under Dissolution may be used with an injection volume of 10 \u00b5L.<\/p>\n When chromatograms are recorded under the prescribed conditions, the retention times relative to capecitabine (retention time, about 16 minutes) are: impurity A, about 0.16; impurity B, about 0.18; impurities D and E (co-elute), 0.94.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (4):<\/p>\n the resolution between the peaks due to impurity A and impurity B is at least 1.5; the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n LIMITS<\/h4>\n Identify any peak corresponding to impurity B using the chromatogram obtained with solution (4) and multiply the peak area by the correction factor of 1.3.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak due to impurity A or impurity B is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n the sum of the areas of any peak due to impurities D and E is not greater than half 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 the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n the sum of the areas of all secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%).<\/p>\n Disregard any peak with an area less than 0.25 times the area of the principal peak in the chromatogram obtained with solution (3) (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. Prepare the solutions immediately before use.<\/p>\n Solvent A<\/em> 5 volumes of acetonitrile, 35 volumes of methanol and 60 volumes of water.<\/p>\n (1) Shake a quantity of powdered tablets containing 60 mg of Capecitabine with 80 mL of solvent A, dilute to 100 mL with the solvent A and filter.<\/p>\n (2) 0.06% w\/v of capecitabine BPCRS in solvent A.<\/p>\n (3) 0.06% w\/v of capecitabine BPCRS and 0.0001% w\/v of capecitabine impurity D EPCRS in solvent A. The chromatographic conditions described under Dissolution may be used with an injection volume of 10 \u00b5L.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Calculate the content of C15H22FN3O6 in the tablets using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Capecitabine.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Pyrimidine analogue; cytotoxic; treatment of cancer. DEFINITION Capecitabine Tablets contain Capecitabine. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of capecitabine, C15H22FN3O6 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of the powdered tablets containing…<\/p>\n","protected":false},"author":5,"featured_media":7223,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-7218","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\/7218","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=7218"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/7218\/revisions"}],"predecessor-version":[{"id":7238,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/7218\/revisions\/7238"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/7223"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=7218"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=7218"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=7218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Dissolution<\/h3>\nCarry out the following procedure protected from light. Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n(b) Use 900 mL of phosphate buffer pH 6.8, at a temperature of 37\u00b0, as the medium.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the content of C15H22FN3O6 in the medium using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n

LIMITS<\/h4>\nThe amount of capecitabine released is not less than 75% (Q) of the stated amount.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of C15H22FN3O6 in the tablets using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n

Dissolution<\/h3>\n
Carry out the following procedure protected from light. Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n
(b) Use 900 mL of phosphate buffer pH 6.8, at a temperature of 37\u00b0, as the medium.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity D and capecitabine is at least 2.0.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of C15H22FN3O6 in the medium using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n

LIMITS<\/h4>\n
The amount of capecitabine released is not less than 75% (Q) of the stated amount.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C15H22FN3O6 in the tablets using the declared content of C15H22FN3O6 in capecitabine BPCRS.<\/p>\n