Description

Carfilzomib Related Impurity CAS NO 168154-76-5 is a critical reference standard used in the pharmaceutical development and quality control of the proteasome inhibitor Carfilzomib. This compound is essential for identifying, quantifying, and monitoring process-related impurities to ensure the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, purification, and batch release of Carfilzomib.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Carfilzomib API batches.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for routine testing in GMP environments to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Carfilzomib synthesis pathway to minimize the formation of this impurity.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to establish impurity limits and justify specifications.
• Stability Studies: Used as a marker to track impurity levels in Carfilzomib drug substance and product under various storage conditions over time.

Basic Information

Item	Details
Product Name	Carfilzomib Related Impurity
CAS No.	168154-76-5
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-methyl-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide; Carfilzomib Impurity; Carfilzomib EP Impurity; Carfilzomib Related Compound; Carfilzomib Process Impurity; (S)-N-((S)-1-(((S)-4-Methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-4-methyl-1-oxopentan-2-yl)-4-methyl-2-(((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide; Kyprolis Related Impurity
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality systems. Each batch is subjected to comprehensive analytical characterization, including HPLC purity determination, structural confirmation (NMR, MS), and residual solvent analysis to ensure identity, potency, and consistency. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing all test results against established specifications. Our quality commitment aligns with the requirements for materials used in pharmaceutical development under ICH Q3A/B and GMP principles.

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. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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% (Area Percent)
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.