{"id":19451,"date":"2025-10-25T09:14:53","date_gmt":"2025-10-25T02:14:53","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19451"},"modified":"2025-10-25T17:36:09","modified_gmt":"2025-10-25T10:36:09","slug":"digoxin-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/digoxin-injection\/","title":{"rendered":"Digoxin Injection"},"content":{"rendered":"

\u200b\u200b\u200b\u200b\u200b\u200b\u200bEdition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

Digoxin Injection<\/p>\n

General Notices<\/p>\n

Action and use\u00a0<\/strong><\/p>\n

Na\/K-ATPase inhibitor; cardiac glycoside.<\/p>\n

DEFINITION<\/h2>\n
Digoxin Injection contains 0.025% w\/v of Digoxin in a suitable vehicle.<\/p>\n
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n
Content of digoxin, C_{41<\/sub>H_{64<\/sub>O_{14<\/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) has the same retention time as that of the principal peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Acidity or alkalinity<\/h3>\n
pH, 6.7 to 7.3, Appendix V L.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in solution A. Solution A\u200322 volumes of mobile phase B and 78 volumes of mobile phase A.<\/p>\n
(1)\u2003Dilute a volume of the injection with sufficient mobile phase A to produce a solution containing 0.00625% w\/v of Digoxin.<\/p>\n
(2)\u2003Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n
(3)\u20030.0005% w\/v each of digoxin EPCRS and lanatoside C (impurity H).<\/p>\n
(4)\u20030.01% w\/v of digoxin for peak identification EPCRS.<\/p>\n
(5)\u2003Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a)\u2003Use a stainless steel column (15 cm \u00d7 3.9 mm) packed with octadecylsilyl silica gel for chromatography (5 \u00b5m) (Waters Symmetry C18 is suitable) fitted with a stainless steel guard column (4 mm \u00d7 3 mm) packed with the same material.<\/p>\n
(b)\u2003Use gradient elution and the mobile phase described below.<\/p>\n
(c)\u2003Use a flow rate of 1.5 mL per minute.<\/p>\n
(d)\u2003Use an ambient column temperature.<\/p>\n
(e)\u2003Use a detection wavelength of 220 nm.<\/p>\n
(f)\u2003Inject 50 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A 10 volumes of acetonitrile R1 and 90 volumes of water.<\/p>\n
Mobile phase B 10 volumes of water and 90 volumes of acetonitrile R1.<\/p>\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/th>\n Mobile phase A (% v\/v)<\/th>\n Mobile phase B (% v\/v)<\/th>\n Comment<\/th>\n<\/tr>\n<\/tbody>\n
0\u20135<\/td>\n 78<\/td>\n 22<\/td>\n isocratic<\/td>\n<\/tr>\n
5\u201315<\/td>\n 78\u219230<\/td>\n 22\u219270<\/td>\n linear gradient<\/td>\n<\/tr>\n
15\u201316<\/td>\n 30\u219278<\/td>\n 70\u219222<\/td>\n linear gradient<\/td>\n<\/tr>\n
16\u201321<\/td>\n 78<\/td>\n 22<\/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 H and digoxin is at least 1.5.<\/p>\n
CALCULATION OF IMPURITIES<\/h4>\n
For each impurity, use the concentration of digoxin in solution (2).<\/p>\n
For the reporting threshold, use the concentration of digoxin in solution (5).<\/p>\n
For peak identification, use solution (4).<\/p>\n
Digoxin retention time: about 4 minutes; relative retention: impurity C, about 0.3; impurity E, about 0.5; impurity F, about 0.6; impurity G, about 0.8; impurity H, about 0.9; impurity K, about 1.6; impurity B, about 2.1; impurity A, about 2.6.<\/p>\n
Correction factors: impurity C, multiply by 0.7.<\/p>\n
LIMITS<\/h4>\n
\u2014 impurity F: not more than 2.5%;<\/p>\n
\u2014 impurities E and K: not more than 1.0% of each;<\/p>\n
\u2014 impurity G: not more than 0.8%;<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 0.5%;<\/p>\n
\u2014 total impurities: not more than 3.5%;<\/p>\n
\u2014 reporting threshold: 0.1%.<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in solution A as described under Related substances.<\/p>\n
(1)\u2003Dilute a volume of the injection with sufficient volume to produce a solution expected to contain 0.00125% w\/v of Digoxin.<\/p>\n
(2)\u20030.00125% w\/v of digoxin EPCRS.<\/p>\n
(3)\u20030.0005% w\/v each of digoxin EPCRS and lanatoside C.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related substances may be used.<\/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 H and digoxin is at least 1.5.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of digoxin, C_{41<\/sub>H_{64<\/sub>O_{14<\/sub>, in the injection from the chromatograms obtained and using the declared content of C_{41<\/sub>H_{64<\/sub>O_{14<\/sub> in digoxin EPCRS.<\/p>\n}}}}}}
STORAGE<\/h2>\n
Digoxin Injection should be protected from light.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Digoxin.<\/p>\n","protected":false},"excerpt":{"rendered":"
\u200b\u200b\u200b\u200b\u200b\u200b\u200bEdition: BP 2025 (Ph. Eur. 11.6 update) Digoxin Injection General Notices Action and use\u00a0 Na\/K-ATPase inhibitor; cardiac glycoside. DEFINITION Digoxin Injection contains 0.025% w\/v of Digoxin in a suitable vehicle. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of digoxin, C41H64O14 95.0 to 105.0% of the stated…<\/p>\n","protected":false},"author":5,"featured_media":19452,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19451","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\/19451","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=19451"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19451\/revisions"}],"predecessor-version":[{"id":19476,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19451\/revisions\/19476"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19452"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19451"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19451"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19451"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/th>\n	Mobile phase A (% v\/v)<\/th>\n	Mobile phase B (% v\/v)<\/th>\n	Comment<\/th>\n<\/tr>\n<\/tbody>\n
0\u20135<\/td>\n	78<\/td>\n	22<\/td>\n	isocratic<\/td>\n<\/tr>\n
5\u201315<\/td>\n	78\u219230<\/td>\n	22\u219270<\/td>\n	linear gradient<\/td>\n<\/tr>\n
15\u201316<\/td>\n	30\u219278<\/td>\n	70\u219222<\/td>\n	linear gradient<\/td>\n<\/tr>\n
16\u201321<\/td>\n	78<\/td>\n	22<\/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 H and digoxin is at least 1.5.<\/p>\n CALCULATION OF IMPURITIES<\/h4>\n For each impurity, use the concentration of digoxin in solution (2).<\/p>\n For the reporting threshold, use the concentration of digoxin in solution (5).<\/p>\n For peak identification, use solution (4).<\/p>\n Digoxin retention time: about 4 minutes; relative retention: impurity C, about 0.3; impurity E, about 0.5; impurity F, about 0.6; impurity G, about 0.8; impurity H, about 0.9; impurity K, about 1.6; impurity B, about 2.1; impurity A, about 2.6.<\/p>\n Correction factors: impurity C, multiply by 0.7.<\/p>\n LIMITS<\/h4>\n \u2014 impurity F: not more than 2.5%;<\/p>\n \u2014 impurities E and K: not more than 1.0% of each;<\/p>\n \u2014 impurity G: not more than 0.8%;<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.5%;<\/p>\n \u2014 total impurities: not more than 3.5%;<\/p>\n \u2014 reporting threshold: 0.1%.<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in solution A as described under Related substances.<\/p>\n (1)\u2003Dilute a volume of the injection with sufficient volume to produce a solution expected to contain 0.00125% w\/v of Digoxin.<\/p>\n (2)\u20030.00125% w\/v of digoxin EPCRS.<\/p>\n (3)\u20030.0005% w\/v each of digoxin EPCRS and lanatoside C.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h3>\n The chromatographic conditions described under Related substances may be used.<\/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 H and digoxin is at least 1.5.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Calculate the content of digoxin, C_{41<\/sub>H_{64<\/sub>O_{14<\/sub>, in the injection from the chromatograms obtained and using the declared content of C_{41<\/sub>H_{64<\/sub>O_{14<\/sub> in digoxin EPCRS.<\/p>\n}}}}}} STORAGE<\/h2>\n Digoxin Injection should be protected from light.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Digoxin.<\/p>\n","protected":false},"excerpt":{"rendered":" \u200b\u200b\u200b\u200b\u200b\u200b\u200bEdition: BP 2025 (Ph. Eur. 11.6 update) Digoxin Injection General Notices Action and use\u00a0 Na\/K-ATPase inhibitor; cardiac glycoside. DEFINITION Digoxin Injection contains 0.025% w\/v of Digoxin in a suitable vehicle. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of digoxin, C41H64O14 95.0 to 105.0% of the stated…<\/p>\n","protected":false},"author":5,"featured_media":19452,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19451","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\/19451","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=19451"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19451\/revisions"}],"predecessor-version":[{"id":19476,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19451\/revisions\/19476"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19452"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19451"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19451"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19451"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Acidity or alkalinity<\/h3>\npH, 6.7 to 7.3, Appendix V L.<\/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 H and digoxin is at least 1.5.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic conditions described under Related substances may be used.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity H and digoxin is at least 1.5.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of digoxin, C41<\/sub>H64<\/sub>O14<\/sub>, in the injection from the chromatograms obtained and using the declared content of C41<\/sub>H64<\/sub>O14<\/sub> in digoxin EPCRS.<\/p>\n

STORAGE<\/h2>\nDigoxin Injection should be protected from light.<\/p>\n

Acidity or alkalinity<\/h3>\n
pH, 6.7 to 7.3, Appendix V L.<\/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 H and digoxin is at least 1.5.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related substances may be used.<\/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 H and digoxin is at least 1.5.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of digoxin, C_{41<\/sub>H_{64<\/sub>O_{14<\/sub>, in the injection from the chromatograms obtained and using the declared content of C_{41<\/sub>H_{64<\/sub>O_{14<\/sub> in digoxin EPCRS.<\/p>\n}}}}}}

STORAGE<\/h2>\n
Digoxin Injection should be protected from light.<\/p>\n