Description

Carfilzomib Impurity 38 is a designated impurity standard used in the analytical profiling and quality control of the proteasome inhibitor Carfilzomib. This compound is critical for pharmaceutical development and manufacturing, enabling the precise identification, quantification, and control of related substances to ensure drug safety and efficacy. It is an essential reference material for research laboratories, analytical service providers, and quality assurance departments within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical validation of Carfilzomib drug substance and drug product.
• Method Development & Validation: Used in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Employed as a system suitability standard and for quantifying impurity levels in routine QC release testing of Carfilzomib batches.
• Stability Studies: Aids in monitoring the formation of this specific impurity during forced degradation and long-term stability studies of Carfilzomib formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Used to identify and track the impurity through various synthesis and purification steps to optimize manufacturing processes.

Basic Information

Product Name	Carfilzomib Impurity 38
CAS No.	1469982-99-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound 38; Carfilzomib EP Impurity G; Carfilzomib USP Impurity; (1S,2S)-2-((S)-2-(2,5-Difluorophenyl)-1-((S)-2-methyloxiran-2-yl)-2-oxoethylamino)-1-hydroxy-4-methyl-1-(2-(2-morpholinoacetamido)ethyl)pentyl carbamate; Carfilzomib Degradant; Carfilzomib Process Impurity
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 38 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, and NMR to confirm identity and purity, ensuring it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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