Description

Vorapaxar Sulfate Impurity CAS NO 618385-09-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Vorapaxar Sulfate. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, validation, and impurity profiling. The availability of this well-characterized impurity supports robust quality control processes and drug development programs.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Vorapaxar Sulfate drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for purity assays and related substance tests.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy for the drug substance.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions to determine product shelf-life.
• Research and Development: Facilitates studies on the chemical behavior, synthesis pathways, and degradation mechanisms of Vorapaxar Sulfate.

Basic Information

Product Name	Vorapaxar Sulfate Impurity
CAS No.	618385-09-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vorapaxar Related Compound; Vorapaxar Sulfate Impurity Standard; Vorapaxar Process Impurity; Zontivity Impurity; SCH 530348 Impurity; (1R,3aR,4aR,9bS)-1-[(1S)-1-Methyl-2-(methylamino)-2-oxoethyl]-N-[(3R)-1-(2,3,4-trifluorophenyl)-3-piperidinyl]-2-oxo-1,2,3,3a,4,4a,5,9b-octahydro-1H-cyclopenta[c]quinoline-4a-carboxamide Sulfate; Thrombin Receptor Antagonist Impurity; Protease-Activated Receptor-1 (PAR-1) Antagonist Impurity
EINECS	Contact for details

Quality Control

Every batch of Vorapaxar Sulfate Impurity CAS NO 618385-09-4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure it meets the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

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 should be kept in a dry environment. For long-term storage, consider conditions recommended for high-value reference standards.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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