Description

Levothyroxine Impurity 14 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of levothyroxine sodium, a widely prescribed thyroid hormone replacement therapy. It is primarily utilized by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine impurity profiling. The availability of a well-characterized impurity standard is essential for meeting stringent regulatory requirements in drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Levothyroxine Sodium API and finished dosage forms.
• Analytical Method Development: Used in the development and optimization of chromatographic methods (HPLC, UPLC) for impurity separation and detection.
• Quality Control & Assurance: Employed as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of levothyroxine formulations to monitor impurity formation over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for the active pharmaceutical ingredient.

Basic Information

Product Name	Levothyroxine Impurity 14
CAS No.	3914-31-6
Molecular Formula	C15H11I4NO4
Molecular Weight	776.87 g/mol
Synonyms	O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine; 3,5-Diiodo-O-(4-hydroxy-3,5-diiodophenyl)-L-tyrosine; 3,5,3',5'-Tetraiodothyronine Impurity; Thyroxine Related Compound; L-Thyroxine Impurity; T4 Impurity; Levothyroxine Related Substance
EINECS	Contact for details

Quality Control

Every batch of Levothyroxine Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, MS, and NMR to ensure compliance with high-grade reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents. We support compliance with cGMP and ICH guidelines for pharmaceutical impurities.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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