Description

Lifitegrast Impurity 8 is a specified organic impurity associated with the active pharmaceutical ingredient Lifitegrast. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality control, and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lifitegrast drug substance and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release: Serves as a critical benchmark in QC laboratories to ensure batches of Lifitegrast meet stringent purity specifications and regulatory filing commitments.
• Regulatory Compliance & Filings: Required for preparing regulatory submission documents (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Used in R&D to study the chemical pathways of impurity formation and to support the synthesis of purer Lifitegrast API.

Basic Information

Product Name	Lifitegrast Impurity 8
CAS No.	2271299-08-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lifitegrast Related Compound 8; Lifitegrast EP Impurity I; Lifitegrast USP Impurity; (2S)-2-[[(2S)-2-[[6-[3-(3,5-Dichloro-4-pyridinyl)-2-propen-1-yl]-5-fluoro-2-pyridinyl]carbonyl]amino]-3-(3-methylsulfonylphenyl)propanoyl]amino]-3-(3-methylsulfonylphenyl)propanoic Acid; SAR 1118 Impurity 8; Xiidra Impurity 8
EINECS	Contact for details

Quality Control

Our Lifitegrast Impurity 8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP 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 must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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