Description

Carfilzomib Impurity 9 is a designated process-related impurity of the proteasome inhibitor Carfilzomib, a critical active pharmaceutical ingredient (API) used in oncology. This compound is essential for pharmaceutical research and development, specifically for method development, stability studies, and ensuring the purity and safety profile of the final drug substance. It serves as a vital reference standard for analytical chemists and quality control laboratories in the pharmaceutical industry, enabling rigorous impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Carfilzomib Impurity 9 in Carfilzomib API and finished drug products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Indicating Studies: Used to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to ensure Carfilzomib batches meet stringent purity specifications set by pharmacopeias (USP, EP).
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for regulatory filings (e.g., with FDA, EMA).
• Process Chemistry Research: Aids in understanding the synthesis pathway of Carfilzomib and optimizing the manufacturing process to minimize impurity formation.

Basic Information

Product Name	Carfilzomib Impurity 9
CAS No.	868540-22-1
Molecular Formula	C40H57N5O7
Molecular Weight	719.92 g/mol
Synonyms	(2S)-N-((S)-1-(((S)-4-Methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)acetamido)-4-methylpentanamide; Carfilzomib Related Compound 9; Carfilzomib EP Impurity I; Carfilzomib USP Impurity; PR-957 Impurity; Kyprolis Impurity; Proteasome Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Carfilzomib Impurity 9 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, related substances analysis, and structural confirmation (NMR, MS) to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment supports your regulatory requirements for pharmaceutical reference 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). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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 guidelines

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