Description

Levothyroxine Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Levothyroxine Sodium, a widely prescribed thyroid hormone replacement therapy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for maintaining compliance with stringent pharmacopeial guidelines.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Levothyroxine Sodium Active Pharmaceutical Ingredient (API).
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Essential for stability studies and degradation pathway profiling of Levothyroxine formulations.
• Used in regulatory compliance and submission to agencies like the FDA and EMA, supporting impurity qualification reports.
• Serves as a key reagent in research and development for studying the metabolism and pharmacokinetics of Levothyroxine.
• Supports pharmacopeial testing to meet USP, EP, or other international monograph requirements for related substances.

Basic Information

Product Name	Levothyroxine Impurity 12
CAS No.	176258-89-2
Molecular Formula	C15H11I4NO4
Molecular Weight	776.87 g/mol
Synonyms	O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine Impurity; Thyroxine Related Compound; L-Thyroxine Impurity 12; 3,5,3',5'-Tetraiodothyronine Impurity; T4 Impurity; Levothyroxine Sodium Impurity 12; (2S)-2-Amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic Acid
EINECS	Contact for details

Quality Control

Every batch of Levothyroxine Impurity 12 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results against established specifications. Our quality commitment supports compliance with cGMP and relevant ICH guidelines for impurities in pharmaceutical substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is light-sensitive (store away from light) and easily oxidized (store under inert atmosphere). For long-term storage, keep the container under an inert atmosphere such as argon or nitrogen in a cool, dry place.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay	95.0% - 105.0% (on anhydrous basis)

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