Description

Levothyroxine Impurity 29 is a specified impurity of the active pharmaceutical ingredient Levothyroxine Sodium, a critical thyroid hormone replacement therapy. This compound is essential for pharmaceutical manufacturers to ensure the purity, safety, and efficacy of their final drug products by monitoring and controlling impurity profiles during development and quality control. It is primarily required by analytical laboratories, quality assurance departments, and R&D teams within the global pharmaceutical and biotechnology sectors for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levothyroxine Sodium API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that Levothyroxine drug substances and products meet stringent pharmacopeial (USP, EP, JP) specifications for related substances.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate thorough impurity characterization.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Levothyroxine Impurity 29
CAS No.	2055-94-9
Molecular Formula	C15H11I4NO4
Molecular Weight	834.87 g/mol
Synonyms	O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine; Thyroxine Impurity; T4 Impurity; 3,5,3',5'-Tetraiodothyronine Impurity; Levothyroxine Related Compound; L-Thyroxine Impurity; 2055-94-9; Levothyroxine Sodium Impurity 29
EINECS	Contact for details

Quality Control

Every batch of Levothyroxine Impurity 29 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including purity, chromatographic data, and spectroscopic identification, is provided and available upon request to support your regulatory and quality needs.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.