Description

Carfilzomib Impurity 65 is a structurally defined degradation product and synthetic intermediate critical for the quality control of carfilzomib, a proteasome inhibitor used in oncology therapeutics. This impurity serves as a reference standard for identity confirmation, assay validation, and impurity profiling during pharmaceutical development and regulatory submission. It is essential for manufacturers, contract research organizations (CROs), and quality control laboratories engaged in the production and testing of carfilzomib drug substance and finished dosage forms. Carfilzomib Impurity 65 CAS NO 2177287-70-4 supports robust analytical method development and compliance with ICH Q3B(R3) guidelines for residual impurities.

Application

• Primary reference standard for HPLC and UPLC method validation in carfilzomib stability-indicating assays
• Qualitative and quantitative calibration material for LC-MS/MS impurity identification and quantification
• Forced degradation study component to assess carfilzomib’s susceptibility to oxidative, photolytic, and hydrolytic stress
• Supporting documentation for FDA, EMA, PMDA, and NMPA regulatory filings (IND, IMPD, NDA, MAA)
• Proficiency testing and inter-laboratory comparison programs in GMP-compliant QC labs
• Development of pharmacopeial monographs (USP, EP, JP) for carfilzomib-related substances
• Stability-indicating method transfer between manufacturing sites and CMOs
• Reference material for genotoxic impurity risk assessment per ICH M7(R2)

Basic Information

Product Name	Carfilzomib Impurity 65
CAS No.	2177287-70-4
Molecular Formula	C40H52N6O8
Molecular Weight	760.90 g/mol
Synonyms	(2S)-N-[(1S,2R)-1-({(2S,3R,5S)-3-[(2-Isopropyl-4-thiazolyl)carbonyl]amino}-5-methyl-1-oxo-2-phenylhexyl)amino]-2-hydroxy-1-phenylpropyl]-3-methylbutanamide; Carfilzomib Related Compound 65; Carfilzomib Degradant 65; CFZ-I65; (2S)-N-[(1S,2R)-1-{[(2S,3R,5S)-3-(2-Isopropylthiazole-4-carbonylamino)-5-methyl-1-oxo-2-phenylhexyl]amino}-2-hydroxy-1-phenylpropyl]-3-methylbutanamide; Carfilzomib Impurity F; USP Carfilzomib Impurity 65
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 match), purity (≥98.5% by HPLC), and absence of residual solvents and heavy metals per ICH Q3C and Q3D guidelines. Testing is performed in accordance with GMP-aligned laboratory practices, and all materials are traceable to certified reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (nitrogen or argon) to prevent oxidation. Keep away from moisture and strong oxidizing agents. Maintain in a well-ventilated area, free from incompatible materials such as strong acids, organic solvents, and fluorides.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
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 limits
Heavy Metals (ICP-MS)	≤10 ppm
Water (Karl Fischer)	≤0.5%

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