General Information

Levothyroxine Impurities and Levothyroxine

For the purity and safety of Levothyroxine, an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Levothyroxine impurity standards. These impurity standards include crucial compounds such as 3,3′,5-Triiodothyroacetic acid, 3, 5- Diiodo- L- thyronine, 3,5-diiodo-L-tyrosine, Levothyroxine Impurity F, Levothyroxine Impurity-J, Levothyroxine-N-Lactoside, T4-Aldehyde (Impurity-I), and more. Additionally, Daicel Pharma provides worldwide delivery options for Levothyroxine impurity standards.

Levothyroxine [CAS: 51-48-9] is a synthetic version of thyroxine, which functions as a thyroid hormone and an antithyroid medication. Triiodothyronine (T3) exerts a range of metabolic stimulation on cells. Levothyroxine, chemically resembling the natural thyroid hormone, mimics its functions and counteracts thyroid-related conditions.

Levothyroxine: Use and Commercial Availability

Levothyroxine, available under brand names such as Euthyrox, Levo-T, Synthroid, Levolet, Levoxyl, Thyquidity, Thyro-Tabs, Tirosint, Tirosint-Sol, Unithroid, etc., is an oral medication primarily used to treat various forms of hypothyroidism. Additionally, Levothyroxine has received US FDA approval for suppressing pituitary thyrotropin as an adjunct treatment for well-differentiated thyroid cancer dependent on thyrotropin.

Levothyroxine Structure and Mechanism of Action  

The chemical name of Levothyroxine is O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine. Its chemical formula is C₁₅H₁₁I₄NO_4, and its molecular weight is approximately 776.87 g/mol.

Levothyroxine directly influences DNA transcription to increase body metabolism by increasing gluconeogenesis, protein synthesis, the mobilization of glycogen stores, and other functions.

Levothyroxine Impurities and Synthesis 

Levothyroxine impurities refer to unintended substances that may be present in Levothyroxine formulations. They can arise during the manufacturing process¹ or storage of the medication. It is crucial to monitor and control impurity levels in Levothyroxine as they can affect the drug’s purity, potency, and safety. Stringent quality control measures help minimize impurity levels and ensure the reliability and efficacy of Levothyroxine for the treatment of hypothyroidism. By maintaining strict standards, pharmaceutical manufacturers strive to provide patients with high-quality Levothyroxine formulations that meet regulatory requirements and deliver the intended therapeutic benefits.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Levothyroxine impurity standards, which include 3,3′,5-Triiodothyroacetic acid, 3, 5- Diiodo- L- thyronine, 3,5-diiodo-L-tyrosine, Levothyroxine Impurity F, Levothyroxine Impurity-J, Levothyroxine-N-Lactoside, T4-Aldehyde (Impurity-I), and more. In addition, we offer deuterium-labeled Levothyroxine standards like Levothyroxine-D3, which is essential for conducting bioanalytical research and BA/BE studies. Our Levothyroxine impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques,1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Levothyroxine impurity standards, degradation products, and labeled compounds to evaluate the effectiveness of generic Levothyroxine. Each delivery has a comprehensive characterization report.