Description

Carfilzomib Impurity CAS NO 1541171-65-6 is a high-purity chemical reference standard used in the research, development, and quality control of the proteasome inhibitor Carfilzomib. This impurity is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) by enabling accurate identification, quantification, and control of process-related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on oncology drug development and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Carfilzomib.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels in Carfilzomib API, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings (e.g., FDA, EMA) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies of Carfilzomib formulations.
• Process Chemistry R&D: Used by chemists to study and optimize the Carfilzomib synthesis pathway, helping to minimize the formation of this specific impurity.
• Pharmacopoeial Testing: Supports testing protocols as per USP, EP, or other pharmacopoeia monographs for Carfilzomib.

Basic Information

Product Name	Carfilzomib Impurity
CAS No.	1541171-65-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound; Carfilzomib Process Impurity; Carfilzomib Degradant; (S)-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-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide; Carfilzomib Analog; Kyprolis Impurity; Proteasome Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic methods, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH guidelines for impurities in new drug substances.

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 to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.