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Eltrombopag Acyl Glucuronide CAS NO 1396009-05-4


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CAS No.:1396009-05-4

Grade:Pharmacy Grade

Content:99.9%

Brand:Customizable

Packaging:Customizable

Description

Eltrombopag Acyl Glucuronide is a key metabolite of the active pharmaceutical ingredient Eltrombopag, a thrombopoietin receptor agonist. This compound is of critical importance in pharmaceutical research and development for comprehensive drug metabolism and pharmacokinetic (DMPK) studies. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development, metabolite profiling, and regulatory submission support.

Application

  • Reference Standard for Bioanalysis: Serves as a certified standard for the quantification of Eltrombopag metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS or HPLC-UV methods.
  • Metabolite Identification & Profiling: Essential for structural confirmation and understanding the metabolic pathways of Eltrombopag during preclinical and clinical studies.
  • Pharmacokinetic (PK) Studies: Used to accurately measure the concentration-time profile of this specific metabolite, informing dosing and safety assessments.
  • Impurity Characterization: Acts as a critical impurity standard in the stability testing and quality control of Eltrombopag drug substance and drug product.
  • Regulatory Compliance: Supports investigational new drug (IND) and new drug application (NDA) submissions by providing definitive metabolite data to health authorities like the FDA and EMA.
  • Toxicology Studies: Employed in safety assessment programs to evaluate the potential biological activity and toxicity of the acyl glucuronide metabolite.

Basic Information

Product Name Eltrombopag Acyl Glucuronide
CAS No. 1396009-05-4
Molecular Formula C33H35N4O8
Molecular Weight 615.66 g/mol
Synonyms Eltrombopag O-Acyl-β-D-Glucuronide; 3-{2-[(1Z)-1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2-hydroxybenzoic acid 1-(β-D-Glucopyranuronosyl) ester; SB-497115 Acyl Glucuronide; Promacta Metabolite; Revolade Metabolite; Eltrombopag Glucuronide Metabolite
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Quality Control

Our Eltrombopag Acyl Glucuronide is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, LC-MS identity confirmation, and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) with detailed chromatographic data are provided to support your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store desiccated at -20°C or below. Allow the product to equilibrate to room temperature before opening to prevent moisture condensation.

Specification

Item Specification
Appearance White to off-white solid
Identification (HPLC) Conforms to reference standard
Identification (MS) Conforms to structure
Purity (HPLC) ≥ 95.0%
Water Content (KF) ≤ 5.0%
Residual Solvents (GC) Complies with ICH guidelines

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

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