Description

Carfilzomib Impurity 2 is a designated process-related impurity of the proteasome inhibitor Carfilzomib, a critical oncology drug. This high-purity reference standard is essential for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is primarily required by analytical laboratories and quality control units within pharmaceutical and biotechnology companies for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Carfilzomib drug substance and drug products.
• Method Development & Validation: Critical for developing and validating robust analytical methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance: Used in routine batch testing to ensure Carfilzomib APIs and finished products meet stringent ICH impurity guidelines.
• Stability Studies: Employed to track the formation and level of this impurity over time under various storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Carfilzomib Impurity 2
CAS No.	1541172-75-1
Molecular Formula	C40H57N5O7
Molecular Weight	719.92 g/mol
Synonyms	(2S)-N-[(2S)-1-[[(2S)-4-Methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]-4-[[4-(morpholin-4-yl)phenyl]methyl]-1-oxo-1,2,3,4-tetrahydroisoquinoline-2-carboxamide; Carfilzomib Related Compound; Carfilzomib EP Impurity; Carfilzomib USP Impurity; Process Impurity of Carfilzomib; Kyprolis Impurity
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 2 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and ensure high purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3A/B guidelines.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. Desiccants are recommended for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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