Description

Lifitegrast Impurity 12 is a specified impurity and reference standard used in the analytical profiling and quality control of Lifitegrast, a pharmaceutical active ingredient. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of ophthalmic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Lifitegrast drug substance and drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control & Batch Release: Employed in routine QC testing to monitor and control the level of this specific impurity in accordance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and qualification data.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions.
• Research and Development: Facilitates process chemistry optimization and impurity fate and tolerance studies during API synthesis.

Basic Information

Product Name	Lifitegrast Impurity 12
CAS No.	2295862-00-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lifitegrast Related Compound 12; SAR 1118 Impurity 12; (2S)-2-[[(2S)-2-[[6-[3-(2,2-Difluoro-2H-1,3-benzodioxol-5-yl)-3-oxo-1-propen-1-yl]-2-pyridinyl]carbonyl]amino]-3-(1-methyl-1H-tetrazol-5-yl)sulfanyl-1-oxopropyl]amino]-3-methylbutanoic acid (enantiomer); Lifitegrast EP Impurity J; Lifitegrast USP Impurity; Lifitegrast Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lifitegrast Impurity 12 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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