{"id":20871,"date":"2025-10-27T16:54:26","date_gmt":"2025-10-27T09:54:26","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20871"},"modified":"2025-10-27T16:54:42","modified_gmt":"2025-10-27T09:54:42","slug":"liothyronine-for-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/liothyronine-for-injection\/","title":{"rendered":"Liothyronine for Injection"},"content":{"rendered":"

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

Liothyronine for Injection<\/p>\n

General Notices<\/p>\n

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

Thyroid hormone replacement.<\/p>\n

DEFINITION<\/h2>\n
Liothyronine for Injection is a sterile material consisting of Liothyronine Sodium with or without excipients. It is supplied in a sealed container.<\/p>\n
The contents of the sealed container comply with the requirements for Powders for Injections or Infusions stated under Parenteral Preparations and with the following requirements.<\/p>\n
Content of liothyronine sodium, C_{15<\/sub>H_{11<\/sub>I_{3<\/sub>NNaO_{4\u00a0<\/sub><\/strong><\/p>\n}}}}
90.0 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
Clarity and colour of solution<\/h3>\n
Dissolve the contents of a sealed container in water for injections and dilute to produce a final solution containing 0.002% w\/v of Liothyronine Sodium. The solution is clear, Appendix IV A, and colourless, Appendix IV B.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in the mobile phase. Carry out the test protected from light.<\/p>\n
(1)\u2003Dissolve the mixed contents of sealed containers containing 0.025 mg of Liothyronine Sodium with 4 mL and dilute to produce 5 mL.<\/p>\n
(2)\u2003Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n
(3)\u20030.00025% w\/v of liothyronine sodium EPCRS and 0.00005% w\/v of levothyroxine sodium EPCRS (impurity A).<\/p>\n
(4)\u2003Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a)\u2003Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped extra-dense bonded cyanosilyl silica gel for chromatography (5 \u00b5m) (Zorbax Eclipse XDB-CN is suitable).<\/p>\n
(b)\u2003Use isocratic elution and the mobile phase described below.<\/p>\n
(c)\u2003Use a flow rate of 1 mL per minute.<\/p>\n
(d)\u2003Use a column temperature of 60\u00b0.<\/p>\n
(e)\u2003Use a detection wavelength of 225 nm.<\/p>\n
(f)\u2003Inject 50 \u00b5L of each solution.<\/p>\n
(g)\u2003For solution (1), allow the chromatography to proceed for 10 times the retention time of liothyronine.<\/p>\n
MOBILE PHASE<\/h4>\n
5 volumes of orthophosphoric acid, 300 volumes of acetonitrile and 700 volumes of water.<\/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 liothyronine and impurity A is at least 4.0.<\/p>\n
CALCULATION OF IMPURITIES<\/h4>\n
For impurity A, use the concentration of impurity A in solution (3).<\/p>\n
For each unspecified impurity, use the concentration of liothyronine in solution (2).<\/p>\n
For the reporting threshold, use the concentration of liothyronine in solution (4).<\/p>\n
For peak identification, use solution (3).<\/p>\n
Liothyronine retention time: about 4 minutes.<\/p>\n
Relative retention: impurity B, about 0.5; impurity E, about 0.7; impurity A, about 1.4; impurity C, about 5.0 and impurity D, about 5.7.<\/p>\n
LIMITS<\/h4>\n
\u2014 impurity A, not more than 1.0%;<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 1.0%;<\/p>\n
\u2014 total impurities: not more than 3.0%;<\/p>\n
\u2014 reporting threshold: 0.1%.<\/p>\n
Uniformity of content<\/h3>\n
Sealed containers containing the equivalent of 2 mg or less of Liothyronine Sodium comply with the requirements stated under Parenteral Preparations, Powders for Injections or Infusions. Use the individual results obtained in the Assay.<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions, prepared in the mobile phase. Carry out the test protected from light.<\/p>\n
(1)\u2003Dissolve the contents of a sealed container to produce a solution containing 0.0005% w\/v of Liothyronine Sodium. (2)\u20030.0005% w\/v of liothyronine sodium EPCRS.<\/p>\n
(3)\u20030.0005% w\/v of liothyronine sodium EPCRS and 0.0005% w\/v of levothyroxine sodium EPCRS.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic procedure 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 liothyronine and impurity A is at least 4.0.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{15<\/sub>H_{11<\/sub>I_{3<\/sub>NNaO_{4<\/sub> in the sealed containers using the chromatograms obtained and the declared content of C_{15<\/sub>H_{11<\/sub>I_{3<\/sub>NNaO_{4<\/sub> in liothyronine sodium EPCRS.<\/p>\n}}}}}}}}
STORAGE<\/h2>\n
Liothyronine for Injection should be protected from light.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Liothyronine Sodium.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Liothyronine for Injection General Notices Action and use\u00a0 Thyroid hormone replacement. DEFINITION Liothyronine for Injection is a sterile material consisting of Liothyronine Sodium with or without excipients. It is supplied in a sealed container. The contents of the sealed container comply with the requirements for Powders for Injections…<\/p>\n","protected":false},"author":5,"featured_media":20878,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20871","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\/20871","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=20871"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20871\/revisions"}],"predecessor-version":[{"id":20889,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20871\/revisions\/20889"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20878"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20871"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20871"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20871"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Clarity and colour of solution<\/h3>\nDissolve the contents of a sealed container in water for injections and dilute to produce a final solution containing 0.002% w\/v of Liothyronine Sodium. The solution is clear, Appendix IV A, and colourless, Appendix IV B.<\/p>\n

MOBILE PHASE<\/h4>\n5 volumes of orthophosphoric acid, 300 volumes of acetonitrile and 700 volumes of water.<\/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 liothyronine and impurity A is at least 4.0.<\/p>\n

LIMITS<\/h4>\n\u2014 impurity A, not more than 1.0%;<\/p>\n\u2014 unspecified impurities: for each impurity, not more than 1.0%;<\/p>\n\u2014 total impurities: not more than 3.0%;<\/p>\n\u2014 reporting threshold: 0.1%.<\/p>\n

Uniformity of content<\/h3>\nSealed containers containing the equivalent of 2 mg or less of Liothyronine Sodium comply with the requirements stated under Parenteral Preparations, Powders for Injections or Infusions. Use the individual results obtained in the Assay.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic procedure 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 liothyronine and impurity A is at least 4.0.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of C15<\/sub>H11<\/sub>I3<\/sub>NNaO4<\/sub> in the sealed containers using the chromatograms obtained and the declared content of C15<\/sub>H11<\/sub>I3<\/sub>NNaO4<\/sub> in liothyronine sodium EPCRS.<\/p>\n

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

Clarity and colour of solution<\/h3>\n
Dissolve the contents of a sealed container in water for injections and dilute to produce a final solution containing 0.002% w\/v of Liothyronine Sodium. The solution is clear, Appendix IV A, and colourless, Appendix IV B.<\/p>\n

MOBILE PHASE<\/h4>\n
5 volumes of orthophosphoric acid, 300 volumes of acetonitrile and 700 volumes of water.<\/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 liothyronine and impurity A is at least 4.0.<\/p>\n

LIMITS<\/h4>\n
\u2014 impurity A, not more than 1.0%;<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 1.0%;<\/p>\n
\u2014 total impurities: not more than 3.0%;<\/p>\n
\u2014 reporting threshold: 0.1%.<\/p>\n

Uniformity of content<\/h3>\n
Sealed containers containing the equivalent of 2 mg or less of Liothyronine Sodium comply with the requirements stated under Parenteral Preparations, Powders for Injections or Infusions. Use the individual results obtained in the Assay.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic procedure 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 liothyronine and impurity A is at least 4.0.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{15<\/sub>H_{11<\/sub>I_{3<\/sub>NNaO_{4<\/sub> in the sealed containers using the chromatograms obtained and the declared content of C_{15<\/sub>H_{11<\/sub>I_{3<\/sub>NNaO_{4<\/sub> in liothyronine sodium EPCRS.<\/p>\n}}}}}}}}

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