Description

Carfilzomib Impurity 52 is a structurally defined degradation product and synthetic intermediate critical for the quality control of carfilzomib, a proteasome inhibitor used in oncology therapeutics. It serves as an essential reference standard for method development, validation, and impurity profiling in pharmaceutical manufacturing and regulatory testing. This compound is indispensable for contract research organizations (CROs), active pharmaceutical ingredient (API) manufacturers, and quality control laboratories requiring high-fidelity analytical references to ensure compliance with ICH Q3B(R3) guidelines. Carfilzomib Impurity 52 CAS NO 2049024-27-1 supports rigorous batch release and stability studies across global pharmaceutical supply chains.

Application

• Reference standard for HPLC and UPLC method development and validation in carfilzomib API quality control
• Calibration material for quantitative impurity determination per ICH Q2(R2) and USP <1058>
• Stability-indicating assay support for forced degradation studies (acid/base/hydrolysis, oxidation, photolysis)
• Qualification of impurity thresholds during regulatory submissions (FDA, EMA, PMDA)
• Use in pharmacopeial monograph compliance (USP-NF, Ph. Eur., JP)
• Proficiency testing and inter-laboratory comparison programs for QC labs
• Raw material qualification for carfilzomib synthesis process optimization
• Supporting root cause analysis of out-of-specification (OOS) results in commercial manufacturing

Basic Information

Product Name	Carfilzomib Impurity 52
CAS No.	2049024-27-1
Molecular Formula	C40H52N6O7
Molecular Weight	744.89 g/mol
Synonyms	(2S)-N-[(1S,2R)-3-[[(2S,3R,5S)-3,5-Dihydroxy-2-[(2-methylpropanoyl)amino]-1-oxo-4-phenylbutyl]amino]-1-hydroxy-2-methylpropyl]-3-methyl-2-[(2S)-2-[(2-methylpropanoyl)amino]butanamido]butanamide; Carfilzomib Related Compound 52; Carfilzomib Degradant 52; CFZ-IMP-52; (2S)-N-[(1S,2R)-3-[[(2S,3R,5S)-3,5-dihydroxy-2-[(2-methylpropanoyl)amino]-1-oxo-4-phenylbutyl]amino]-1-hydroxy-2-methylpropyl]-3-methyl-2-[(2S)-2-[(2-methylpropanoyl)amino]butanamido]butanamide; Carfilzomib Impurity G; USP Carfilzomib Related Compound G
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. All batches are tested per ICH Q5A–Q5E guidelines and conform to current Good Manufacturing Practice (cGMP) requirements for reference standards. Testing includes identity confirmation (HPLC retention time match, IR, 1H-NMR), assay (HPLC with UV detection), related substances (HPLC gradient method), residual solvents (GC), water content (Karl Fischer), and heavy metals (ICP-MS). Each COA reports purity ≥98.5% (area %), single impurity ≤0.3%, and meets USP <1225> and Ph. Eur. 5.12 requirements for certified reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (argon or nitrogen) to prevent degradation. Due to hygroscopic nature, maintain low-humidity conditions (<30% RH) and minimize exposure to ambient air during handling. Avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥98.5% (area %)
Related Substances (HPLC)	Single impurity ≤0.3%; Total impurities ≤1.0%
Water (KF)	≤0.5%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals	≤10 ppm

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