Description

Carfilzomib Impurity 50 is a structurally defined degradation product and synthetic reference standard used in the quality control of the proteasome inhibitor drug carfilzomib. It plays a critical role in ensuring analytical method validation, stability-indicating assay development, and regulatory compliance for pharmaceutical manufacturers and contract research organizations. This impurity is essential for accurate identification, quantification, and qualification of potential process-related or degradation-related impurities in carfilzomib drug substance and product batches. Carfilzomib Impurity 50 CAS NO 869804-84-2 is supplied exclusively for laboratory research and pharmaceutical development—not for human or veterinary use.

Application

• Reference standard for HPLC and UPLC method development and validation in carfilzomib drug substance testing
• Qualification and quantification of impurity profiles per ICH Q3B(R2) guidelines
• Stability-indicating assay support during accelerated and long-term stability studies
• Calibration standard for LC-MS/MS quantitation of carfilzomib-related impurities
• Use in forced degradation studies to characterize oxidative, hydrolytic, and photolytic degradation pathways
• Supporting regulatory submissions (FDA, EMA, PMDA) requiring comprehensive impurity control strategies
• Quality assurance in API manufacturing and release testing at contract manufacturing organizations (CMOs)
• Research applications in structure–activity relationship (SAR) studies of proteasome inhibitors

Basic Information

Product Name	Carfilzomib Impurity 50
CAS No.	869804-84-2
Molecular Formula	C40H55N7O7
Molecular Weight	761.92 g/mol
Synonyms	(2S)-N-[(1S,2R)-1-({(2S,3R,5S)-3-[(2S)-2-[(tert-Butoxycarbonyl)amino]-3-methylbutanoyl]amino}-5-[(tert-butoxycarbonyl)amino]-1-oxo-2-(phenylmethyl)pentyl)carbamoyl]-2-hydroxy-1-phenylethyl)-3-methylbutanamide; Carfilzomib Related Compound 50; Carfilzomib Degradant 50; (2S)-N-[(1S,2R)-1-{[(2S,3R,5S)-3-[(2S)-2-[(tert-Butoxycarbonyl)amino]-3-methylbutanoyl]amino}-5-[(tert-butoxycarbonyl)amino]-1-oxo-2-benzylpentyl)carbamoyl]-2-hydroxy-1-phenylethyl)-3-methylbutanamide; Bortezomib analog impurity (structural misassignment correction); USP Carfilzomib Impurity 50; EP Carfilzomib Impurity D
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is tested for identity (IR, HPLC retention time comparison), purity (≥98.5% by HPLC), residual solvents (ICH Q3C compliant), and heavy metals (≤10 ppm). Testing follows current USP & EP general chapters and adheres to GMP-aligned laboratory practices.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (argon or nitrogen) to prevent oxidation. Keep desiccated; avoid exposure to ambient humidity. Handle in a controlled environment with minimal air exchange to maintain integrity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard (±0.2 min)
Assay (HPLC)	98.5% – 101.0%
Related Substances (HPLC)	Single impurity ≤0.3%; Total impurities ≤0.5%
Residual Solvents (GC)	Meets ICH Q3C Class 3 limits
Water (Karl Fischer)	≤0.5%
Heavy Metals	≤10 ppm

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