Description

Lifitegrast Impurity C is a specified impurity of the active pharmaceutical ingredient Lifitegrast, a lymphocyte function-associated antigen-1 (LFA-1) antagonist used in ophthalmic solutions. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Primary use as a certified reference standard for the quantification of Lifitegrast Impurity C in drug substance and drug product.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Lifitegrast.
• Essential for quality control and assurance laboratories to establish impurity acceptance criteria.
• Serves as a key material in regulatory submissions (e.g., FDA, EMA) to support drug approval dossiers.
• Utilized in pharmaceutical research to study the chemical and metabolic behavior of Lifitegrast-related substances.

Basic Information

Product Name	Lifitegrast Impurity C
CAS No.	851785-70-1
Molecular Formula	C29H26N2O3S
Molecular Weight	482.59 g/mol
Synonyms	(2S)-2-[(6-{[(3R)-3-(3-Methylisothiazol-5-yl)-3-{[(2S)-tetrahydrofuran-2-yl]methoxy}propanoyl]amino}-3,4-dihydro-2H-chromen-3-yl)oxy]acetic Acid; SAR 1118 Impurity C; Lifitegrast Related Compound C; (S)-2-((6-((R)-3-(3-Methylisothiazol-5-yl)-3-((S)-Tetrahydrofuran-2-ylmethoxy)propanamido)-3,4-dihydro-2H-chromen-3-yl)oxy)acetic Acid; Lifitegrast EP Impurity C; Lifitegrast USP Impurity C
EINECS	Contact for details

Quality Control

Our Lifitegrast Impurity C is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with batch-specific data, ensuring traceability and compliance with ICH guidelines Q3A(R2) and Q3B(R2) for impurities. Certificates of Analysis (COA) are 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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