Description

Carfilzomib Impurity 35 is a designated impurity reference standard used in the analytical profiling and quality control of the proteasome inhibitor Carfilzomib. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Carfilzomib-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Carfilzomib Impurity 35 in Carfilzomib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) & Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes.

Basic Information

Product Name	Carfilzomib Impurity 35
CAS No.	2177287-68-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound 35; Carfilzomib EP Impurity 35; Carfilzomib USP Impurity 35; Carfilzomib Process Impurity; (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-dioxopyrrolidin-1-yl)propanamido)-4-methylpentanamide (IUPAC-based); Kyprolis Impurity 35; PR-171 Impurity 35
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 35 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided and are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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