Description

Carfilzomib Impurity 40 is a designated impurity associated with the proteasome inhibitor Carfilzomib, a critical active pharmaceutical ingredient (API) used in oncology. This compound is essential for pharmaceutical research and development, specifically for method development, stability studies, and ensuring the purity and safety of the final drug product. It is a vital reference standard for analytical laboratories and manufacturers in the pharmaceutical industry focused on quality control and regulatory compliance for antineoplastic agents.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Carfilzomib.
• Analytical Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to detect and quantify impurities.
• Stability Studies and Forced Degradation: Employed to identify and monitor degradation products in Carfilzomib drug substance and drug product under various stress conditions.
• Quality Control and Batch Release: Serves as a system suitability component and an impurity marker in the routine QC testing of Carfilzomib API to ensure it meets pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., FDA, EMA) to support the safety profile of the drug.
• Research on Degradation Pathways: Aids in understanding the chemical behavior and degradation mechanisms of Carfilzomib.

Basic Information

Product Name	Carfilzomib Impurity 40
CAS No.	1545468-80-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound 40; Carfilzomib EP Impurity C; Carfilzomib Impurity C (EP); Carfilzomib Process Impurity; (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-ylacetamido)-4-phenylbutanoyl]amino]pentanamide (IUPAC); Kyprolis Impurity; PR-171 Impurity
EINECS	Contact for details

Quality Control

Every batch of Carfilzomib Impurity 40 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator to maintain stability.

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%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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