Description

Levothyroxine Related Compound (2-Acetamido-3-(3,5-Diiodo-4-(4-Methoxyphenoxy)Phenyl) Propanoic Acid) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a key impurity marker and analytical standard in the development and validation of methods for levothyroxine sodium, a vital thyroid hormone replacement therapy. It is essential for manufacturers, analytical laboratories, and regulatory bodies requiring precise identification and quantification of related substances to ensure drug safety and efficacy. The product is supplied with comprehensive analytical data to support rigorous pharmaceutical applications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in levothyroxine sodium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and mass spectrometry (MS) methods for related substance analysis.
• Quality Control (QC) & Stability Testing: Used in routine QC testing and stability studies to monitor impurity profiles and ensure batch-to-batch consistency and product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Pharmacopoeial Testing: Employed in testing to meet the stringent specifications of pharmacopoeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia) for levothyroxine.
• Research & Development (R&D): Utilized in synthetic chemistry research to study degradation pathways and to synthesize and characterize other related compounds.

Basic Information

Product Name	Levothyroxine Related Compound (2-Acetamido-3-(3,5-Diiodo-4-(4-Methoxyphenoxy)Phenyl) Propanoic Acid)
CAS No.	886203-79-8
Molecular Formula	C18H17I2NO5
Molecular Weight	589.14 g/mol
Synonyms	2-Acetamido-3-(3,5-diiodo-4-(4-methoxyphenoxy)phenyl)propanoic Acid; Levothyroxine Impurity; Thyroxine Related Compound A; T4 Related Compound; O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine Impurity; 3,5-Diiodo-4-(4-methoxyphenoxy)-2-acetamidophenylpropionic Acid; L-Thyroxine Related Substance
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, assay, and related substances. Our quality standards align with the requirements for pharmaceutical impurity standards, supporting compliance with ICH, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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