Description

Sodium Levothyroxine Pentahydrate is the sodium salt of the L-isomer of thyroxine, a synthetic thyroid hormone. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of consistent and effective thyroid hormone replacement therapies. It is primarily required by pharmaceutical manufacturers for the production of tablets, capsules, and injectables used to treat conditions such as hypothyroidism, goiter, and thyroid cancer.

Application

• Pharmaceutical API: Core active ingredient in thyroid hormone replacement medications (e.g., Levothyroxine Sodium tablets).
• Hormone Therapy Formulations: Used in the development and production of treatments for hypothyroidism and myxedema coma.
• Veterinary Pharmaceuticals: Incorporated into treatments for thyroid disorders in animals.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in laboratories.
• Clinical Research: Utilized in preclinical and clinical studies investigating thyroid function and related endocrine pathways.
• Diagnostic Aid: Component in certain diagnostic kits and assays for thyroid function testing.

Basic Information

Product Name	Sodium Levothyroxine Pentahydrate
CAS No.	6106-07-6
Molecular Formula	C15H10I4NNaO4 • 5H2O
Molecular Weight	888.93 g/mol (Anhydrous basis: 798.86 g/mol)
Synonyms	Levothyroxine Sodium Pentahydrate; L-Thyroxine Sodium Salt Pentahydrate; T4 Sodium Salt; Synthroid; Levoxyl; Euthyrox; Thyroxine Sodium; 3,5,3',5'-Tetraiodo-L-thyronine Sodium Salt; O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine Sodium Salt
EINECS	Contact for details

Quality Control

Our Sodium Levothyroxine Pentahydrate is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including HPLC assay, related substances analysis, identification, and residual solvent testing to ensure identity, potency, purity, and safety. A detailed Certificate of Analysis (COA) is provided with each shipment to guarantee traceability and supply chain reliability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and opened under conditions of low humidity to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white, crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC, anhydrous basis)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Individual unknown impurity ≤ 0.5%
Water Content (KF)	9.0% - 11.0% (Theoretical for pentahydrate: ~10.1%)
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.