Description

Lifitegrast Impurity D 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 researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Lifitegrast drug substance and drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Lifitegrast products meet stringent pharmacopeial (e.g., USP, ICH) impurity limits.
• Stability Studies: Used to identify and quantify degradation products formed under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Supports impurity profiling, route scouting, and process chemistry optimization during API synthesis.

Basic Information

Product Name	Lifitegrast Impurity D
CAS No.	2641788-18-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lifitegrast Related Compound D; Lifitegrast EP Impurity D; Lifitegrast USP Impurity D; (2S)-2-{[(3-Methyl-4-{[(2-methyl-2-propanyl)oxy]carbonyl}phenyl)carbonyl]amino}-3-{4-[(methylsulfonyl)carbonyl]phenyl}propanoic acid; SAR 1118 Impurity D; (S)-2-(3-Methyl-4-(tert-butoxycarbonyl)benzamido)-3-(4-(methylsulfonyl)phenyl)propanoic acid
EINECS	Contact for details

Quality Control

Our Lifitegrast Impurity D is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via MS and NMR, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified 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.