Description

Levothyroxine Related Compound (2-Acetamido-3-(4-Acetoxy-3,5-Diiodophenyl)Propanoic Acid) is a key chemical reference standard and synthetic intermediate critical for pharmaceutical research and development. This compound is essential for ensuring the quality, purity, and regulatory compliance of levothyroxine sodium, a vital thyroid hormone replacement therapy. It is primarily used by analytical laboratories and pharmaceutical manufacturers engaged in method development, impurity profiling, and stability studies. Our high-purity grade is manufactured under controlled conditions to guarantee batch-to-batch consistency and reliable performance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in levothyroxine sodium active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity Profiling & Method Development: A critical component in developing and validating analytical methods, such as HPLC and LC-MS, to monitor process-related impurities and ensure product safety.
• Stability Indicating Studies: Employed in forced degradation and stability studies to understand the degradation pathways of levothyroxine and establish appropriate shelf-life.
• Synthetic Intermediate: Serves as a key building block in the research-scale synthesis of levothyroxine and its analogs for pharmacological evaluation.
• Quality Control & Assurance: Integral to in-house QC laboratories for routine testing, batch release, and compliance with pharmacopeial monographs (USP, EP, BP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to support regulatory approvals.

Basic Information

Product Name	Levothyroxine Related Compound (2-Acetamido-3-(4-Acetoxy-3,5-Diiodophenyl)Propanoic Acid)
CAS No.	153324-21-1
Molecular Formula	C13H13I2NO5
Molecular Weight	517.05 g/mol
Synonyms	2-Acetamido-3-(4-acetoxy-3,5-diiodophenyl)propanoic Acid; O4-Acetyl-3,5-diiodo-L-thyronine; 3,5-Diiodo-O4-acetyl-L-thyronine; Levothyroxine Impurity; Thyroxine Related Compound A; L-Thyroxine Related Substance; N-Acetyl-3,5-diiodothyronine O4-Acetate
EINECS	Contact for details

Quality Control

Every batch of our Levothyroxine Related Compound is produced and tested in facilities adhering to cGMP guidelines. Quality is assured through a comprehensive battery of analytical tests, including HPLC for purity and related substances, IR and MS for identification, and residual solvent analysis. Our specifications are designed to meet or exceed the requirements of major pharmacopeias. A detailed Certificate of Analysis (COA) documenting identity, purity, and assay results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	97.0% - 103.0%

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