Description

Levothyroxine Sodium Impurity is a high-purity reference standard used for the identification, qualification, and quantification of related substances in active pharmaceutical ingredients (APIs). This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing levothyroxine sodium. It is an essential material for pharmaceutical R&D, quality control laboratories, and regulatory compliance testing within the global life sciences industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Quality Control & Assurance: For the identification and quantification of this specific impurity in Levothyroxine Sodium API batches to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used as a marker to monitor degradation pathways and establish shelf-life for finished dosage forms.
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs) by providing impurity characterization data.
• Research & Development: Facilitates process chemistry optimization to minimize impurity formation during API synthesis.
• Contract Testing Laboratories: Serves as a critical reagent for third-party analysis and batch release testing services.

Basic Information

Product Name	Levothyroxine Sodium Impurity
CAS No.	27566-09-2
Molecular Formula	C15H10I4NNaO4
Molecular Weight	798.84 g/mol
Synonyms	L-Thyroxine Sodium Salt Impurity; T4 Sodium Salt Impurity; Levothyroxine Impurity; Thyroxine Sodium Impurity; O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine Sodium Salt; Sodium Levothyroxine Related Compound; Levothyroxine Sodium Related Substance
EINECS	Contact for details

Quality Control

Every batch of our Levothyroxine Sodium Impurity is manufactured and analyzed under strict quality management systems. The material is characterized and qualified using advanced analytical techniques including HPLC, MS, and NMR to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards align with ICH guidelines and support compliance with cGMP requirements for pharmaceutical reference materials.

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 must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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