Description

Carfilzomib Impurity 34 is a designated impurity associated with the active pharmaceutical ingredient Carfilzomib, a proteasome inhibitor used in oncology. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Carfilzomib-based drug products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Carfilzomib drug substance and drug products.
• Critical component in analytical method development and validation (HPLC, LC-MS) to meet ICH Q3A/B guidelines.
• Used in stability studies to monitor impurity profiles and degradation pathways of Carfilzomib formulations.
• Essential for quality control and assurance in API manufacturing to ensure batch-to-batch consistency and regulatory compliance.
• Valuable material for pharmacological and toxicological research to understand the impact of specific impurities.
• Serves as a calibrant and system suitability test compound in regulated laboratory environments.

Basic Information

Product Name	Carfilzomib Impurity 34
CAS No.	2381627-87-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound 34; Carfilzomib EP Impurity C; 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; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 34 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment to support your regulatory submissions and quality protocols.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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