Description

Levothyroxine Impurity CAS NO 92028-82-5 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in Levothyroxine Sodium API and its finished dosage forms. It is primarily utilized by analytical laboratories and quality control units within the global pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for method development and validation in HPLC and LC-MS analysis of Levothyroxine.
• Quality Control & Assurance: Used as a system suitability standard and for routine impurity monitoring in Active Pharmaceutical Ingredient (API) batch release testing.
• Regulatory Compliance & Filing: Critical for preparing impurity identification reports required for regulatory submissions to agencies like the FDA, EMA, and PMDA.
• Stability Studies: Employed to track the formation and levels of specific degradants in Levothyroxine formulations under various stress conditions.
• Pharmacopoeial Testing: Supports testing in compliance with monographs from USP, EP, BP, and other international pharmacopoeias.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Levothyroxine manufacturing process to minimize impurity formation.

Basic Information

Product Name	Levothyroxine Impurity
CAS No.	92028-82-5
Molecular Formula	C15H11I4NO4
Molecular Weight	776.87 g/mol
Synonyms	O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine; 3,5-Diiodo-L-thyronine; DIT2; Reverse T3 Impurity; 3,3',5'-Triiodo-L-thyronine; Levothyroxine Related Compound; T4 Impurity B; Thyroxine Degradant
EINECS	Contact for details

Quality Control

Every batch of Levothyroxine Impurity (CAS 92028-82-5) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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. Avoid repeated or prolonged exposure to air.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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