Description

Lifitegrast Impurity 3 is a specified impurity of Lifitegrast, a pharmaceutical active ingredient used in the treatment of dry eye disease. This high-purity reference standard is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for research and development laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams to ensure the safety, efficacy, and compliance of the final drug product.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Lifitegrast Impurity 3 in drug substances and products.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in studies to understand the degradation pathways and chemical behavior of Lifitegrast.

Basic Information

Product Name	Lifitegrast Impurity 3
CAS No.	2295862-29-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lifitegrast Related Compound 3; Lifitegrast EP Impurity C; Lifitegrast USP Impurity; (2S)-2-[[(2S)-2-[[6-[3-(3,3-Dimethyl-1-piperazinyl)propoxy]-2,3-difluorophenyl]carbonyl]amino]-3-(3-methylsulfonylphenyl)propanoyl]amino]-3-(4-nitrophenyl)propanoic acid; SAR 1118 Impurity 3; Lifitegrast Degradation Product; Lifitegrast Process Impurity
EINECS	Contact for details

Quality Control

Our Lifitegrast Impurity 3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by techniques such as NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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)	Conforms to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% 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.