Description

Lifitegrast Impurity 14 is a designated chemical reference standard used in the analytical profiling and quality control of Lifitegrast, an ophthalmic pharmaceutical agent. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the drug substance and final medicinal product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Lifitegrast drug substance and drug product.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for impurity profiling.
• Quality Control & Batch Release: Essential for establishing impurity limits, conducting comparative testing, and ensuring batches meet ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., ANDA, NDA) to agencies like the US FDA and EMA.
• Research & Development: Used in R&D to understand degradation pathways and improve the synthetic process of Lifitegrast to minimize impurity formation.

Basic Information

Product Name	Lifitegrast Impurity 14
CAS No.	2295862-24-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lifitegrast Related Compound 14; Lifitegrast EP Impurity 14; Lifitegrast USP Impurity 14; Lifitegrast Degradation Product; SAR 1118 Impurity 14; (S)-2-(2-(Benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid impurity; Lifitegrast Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lifitegrast Impurity 14 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substances, and other relevant analytical tests performed in compliance with current industry and regulatory expectations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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