Description

Carfilzomib Impurity 55 is a designated impurity standard of the proteasome inhibitor Carfilzomib, a critical oncology drug. This high-purity reference material is essential for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the production and analysis of Carfilzomib drug substances and products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Carfilzomib Impurity 55 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Used as a critical component in developing and validating stability-indicating HPLC/UPLC methods for Carfilzomib.
• Quality Control & Batch Release: Employed in routine QA/QC testing to monitor impurity profiles and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Utilized as a marker to track the formation of specific degradation products during forced degradation and long-term stability studies of Carfilzomib.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies in accordance with ICH Q3A and Q3B.
• Process Chemistry Research: Aids in understanding and optimizing the Carfilzomib synthesis pathway by identifying and controlling process-related impurities.

Basic Information

Product Name	Carfilzomib Impurity 55
CAS No.	1809093-03-5
Molecular Formula	C40H57N5O7
Molecular Weight	719.92 g/mol
Synonyms	Carfilzomib Related Compound 55; Carfilzomib EP Impurity G; 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]-1,2,3,4-tetrahydroisoquinoline-2-carboxamide; UNII-0Q6Q4P8C6H; 0Q6Q4P8C6H; Carfilzomib Impurity (Carfilzomib EP Impurity G)
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 55 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.