Description

Lusutrombopag Impurity 5 is a designated impurity of the active pharmaceutical ingredient (API) Lusutrombopag, a thrombopoietin receptor agonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Lusutrombopag drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lusutrombopag API and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Lusutrombopag Impurity 5
CAS No.	2089386-33-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lusutrombopag Related Compound 5; S-888711 Impurity 5; Mulpleta Impurity 5; (2E)-3-[4-[(2Z)-2-(2-Amino-4-oxo-1,4-dihydro-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-3-fluoro-2-(1-hydroxy-1-methylethyl)but-2-enoyl]piperazin-1-yl]-3-oxoprop-2-enenitrile; Lusutrombopag EP Impurity F; Lusutrombopag USP Impurity F
EINECS	Contact for details

Quality Control

Our Lusutrombopag Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via 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 a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation.

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%
Water Content (KF)	≤ 5.0%

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