Description

Levothyroxine Sodium is the sodium salt of the synthetic L-isomer of thyroxine, a critical thyroid hormone. This active pharmaceutical ingredient (API) is essential for the treatment of hypothyroidism and other thyroid-related disorders, ensuring precise metabolic regulation. It is a fundamental component for global pharmaceutical manufacturers producing hormone replacement therapies. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final medicinal products.

Application

• Pharmaceutical API: Primary active ingredient in oral tablets, capsules, and injectable formulations for thyroid hormone replacement therapy.
• Hypothyroidism Treatment: Manufacture of medications used to treat underactive thyroid glands (hypothyroidism), including conditions like myxedema.
• Thyroid Cancer Suppression Therapy: Used in the management of certain thyroid cancers to suppress thyroid-stimulating hormone (TSH).
• Diagnostic Aid: Component in diagnostic tests and protocols for assessing thyroid function.
• Veterinary Medicine: Used in hormone replacement therapies for hypothyroid conditions in animals.
• Research & Development: Critical reference standard and reagent in biochemical, pharmacological, and endocrinological research.

Basic Information

Product Name	Levothyroxine Sodium
CAS No.	55-03-8
Molecular Formula	C15H10I4NNaO4 • xH2O
Molecular Weight	798.86 (anhydrous basis)
Synonyms	L-Thyroxine Sodium Salt; T4 Sodium Salt; Sodium Levothyroxine; Levothyroxine Sodium Pentahydrate; Synthroid; Euthyrox; Levoxyl; Thyroxine Sodium; O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine Sodium Salt; L-3,3',5,5'-Tetraiodothyronine Sodium Salt
EINECS	200-223-9

Quality Control

Our Levothyroxine Sodium is manufactured under strict quality management systems. It is tested to meet stringent specifications aligned with major pharmacopoeial standards such as USP and EP. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure compliance for pharmaceutical use. We are committed to providing materials that support our clients' regulatory submissions and GMP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, consider storage under inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to faint yellow, 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 (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.