Description

Sodium Levothyroxine CAS NO 25416-65-3 is the sodium salt of the synthetic thyroid hormone L-thyroxine (T4). This high-purity active pharmaceutical ingredient (API) is critical for the formulation of consistent and effective hormone replacement therapies. It is primarily required by pharmaceutical manufacturers for the production of tablets, capsules, and injectables used to treat hypothyroidism and thyroid cancer.

Application

• Pharmaceutical API: Primary active ingredient in oral tablets and capsules for the treatment of hypothyroidism (underactive thyroid).
• Hormone Replacement Therapy (HRT): Used in formulations to restore normal thyroid hormone levels in patients post-thyroidectomy or with thyroid disorders.
• Thyroid Cancer Treatment: Component in therapeutic regimens, including thyroid-stimulating hormone (TSH) suppression therapy.
• Veterinary Pharmaceuticals: Used in medications for treating hypothyroidism in dogs and other animals.
• Reference Standard: Serves as a high-purity standard in analytical laboratories for quality control and research.
• Clinical Research: Utilized in biochemical studies and the development of new therapeutic delivery systems.

Basic Information

Item	Detail
Product Name	Sodium Levothyroxine
CAS No.	25416-65-3
Molecular Formula	C15H10I4NNaO4
Molecular Weight	798.86 g/mol
Synonyms	Levothyroxine Sodium; L-Thyroxine Sodium Salt; T4 Sodium Salt; Thyroxine Sodium; Synthroid (Brand Name); Levoxyl (Brand Name); Euthyrox (Brand Name); (2S)-2-Amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid sodium salt
EINECS	Contact for details

Quality Control

Our Sodium Levothyroxine is manufactured under strict quality systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm

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