Description

Carfilzomib Impurity 15 is a high-purity chemical reference standard used in the analytical profiling and quality control of the proteasome inhibitor Carfilzomib. This impurity is critical for pharmaceutical development and manufacturing, enabling precise identification, quantification, and control of related substances to ensure drug safety and efficacy. It is an essential material for researchers and quality control laboratories in the pharmaceutical industry focused on oncology drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Carfilzomib-related substances in Active Pharmaceutical Ingredient (API) and finished drug product analysis.
• Method Development and Validation: Used in developing and validating robust analytical methods, primarily HPLC and UPLC, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Employed as a system suitability and calibration standard in routine QC testing to monitor batch-to-batch consistency and purity of Carfilzomib.
• Stability Studies: Utilized to track the formation of degradation products during forced degradation and long-term stability studies of Carfilzomib drug substance and products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify the control strategy for Carfilzomib.
• Research and Development: Aids in understanding the degradation pathways and chemical behavior of Carfilzomib during synthesis, formulation, and storage.

Basic Information

Product Name	Carfilzomib Impurity 15
CAS No.	1541171-67-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound 15; Carfilzomib EP Impurity C; Carfilzomib USP Impurity; Carfilzomib Degradant; (S)-2-((S)-2-(2,5-Difluorophenyl)-1-((S)-2-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopropan-2-ylamino)-4-methylpentanamido)-N-((S)-1-((S)-2-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopropan-2-ylamino)-1-oxo-3-phenylpropan-2-yl)-4-phenylbutanamide; Kyprolis Impurity 15
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 15 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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.