Description

Levothyroxine Related Compound (n-Acetyl 3,5-Diiodo-L-Tyrosine Methyl Ester) is a high-purity chemical reference standard and synthetic intermediate critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of thyroid hormone medications through precise analytical control. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, impurity profiling, and quality control of levothyroxine sodium and related APIs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances and impurities in Levothyroxine Sodium API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for pharmaceutical quality control.
• Process Chemistry & Impurity Profiling: Employed as a key intermediate or marker in the synthesis and purification process of thyroid hormones, aiding in the identification of process-related impurities.
• Metabolic and Pharmacokinetic Studies: Utilized in research to study the metabolic pathways, stability, and degradation profiles of thyroid hormone analogs.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH guidelines.

Basic Information

Product Name	Levothyroxine Related Compound (n-Acetyl 3,5-Diiodo-L-Tyrosine Methyl Ester)
CAS No.	56460-41-4
Molecular Formula	C12H13I2NO4
Molecular Weight	504.04 g/mol
Synonyms	N-Acetyl-3,5-diiodo-L-tyrosine methyl ester; Methyl N-acetyl-3,5-diiodo-L-tyrosinate; 3,5-Diiodo-N-acetyl-L-tyrosine methyl ester; Ac-Diiodo-Tyr-OMe; Levothyroxine Impurity; Thyroxine Related Compound A; O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-N-acetyl-L-tyrosine methyl ester (common misnomer); L-Tyrosine, N-acetyl-3,5-diiodo-, methyl ester
EINECS	Contact for details

Quality Control

Our Levothyroxine Related Compound is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and related substances, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets stringent standards for use as a reference material. Certificates of Analysis (COA) with detailed chromatograms and spectroscopic data are provided and can be tailored to support specific pharmacopeial (USP/EP) or internal method requirements.

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) and must be kept under anhydrous conditions. 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 matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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