Description

Levothyroxine Impurity 14 is a high-purity reference standard used for the identification, qualification, and quantification of related substances in Levothyroxine Sodium active pharmaceutical ingredient (API) and finished drug products. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by monitoring and controlling impurities. It is an essential tool for quality control, method validation, and stability studies within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical testing of Levothyroxine Sodium.
• Impurity Profiling & Identification: Used in HPLC, UPLC, and LC-MS methods to identify and quantify this specific impurity in API batches.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods as per ICH guidelines.
• Quality Control & Release Testing: Employed in routine QC testing to ensure impurity levels are within specified limits (e.g., ICH Q3A/B).
• Stability Studies: Used to monitor the formation of degradation products in Levothyroxine formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).

Basic Information

Product Name	Levothyroxine Impurity 14
CAS No.	854646-83-6
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; Levothyroxine Related Substance 14; T4 Impurity 14; 3,5,3',5'-Tetraiodothyronine Impurity; (2S)-2-Amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid; L-Thyroxine Impurity 14
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, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.