Description

Carfilzomib Impurity 14 is a designated reference standard used for the analytical profiling and quality control of the proteasome inhibitor Carfilzomib. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API). It is primarily utilized in research and development, method validation, and regulatory compliance within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Carfilzomib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Carfilzomib meets stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, aiding in determining the shelf-life of the drug substance.
• Process Chemistry Research: Helps chemists understand and optimize the Carfilzomib synthesis pathway by identifying and controlling key process impurities.

Basic Information

Product Name	Carfilzomib Impurity 14
CAS No.	1396006-47-5
Molecular Formula	C40H57N5O7
Molecular Weight	719.91 g/mol
Synonyms	Carfilzomib Related Compound 14; Carfilzomib EP Impurity H; Carfilzomib USP 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-[[4-(morpholin-4-yl)phenyl]methyl]-1-oxo-1,2-dihydro-3H-pyrrolo[3,4-c]pyridine-2-carboxamide; Carfilzomib Process Impurity; Carfilzomib Degradant
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified purity criteria.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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 guidelines

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