Description

Carfilzomib Impurity 56 is a high-purity chemical reference standard used in the research, development, and quality control of the proteasome inhibitor Carfilzomib. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification. It is an essential material for analytical laboratories, pharmaceutical R&D teams, and quality assurance departments involved in the synthesis and purification of Carfilzomib.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analytical method development and validation of Carfilzomib API.
• Quality Control & Assurance (QC/QA): Used in HPLC, LC-MS, and other chromatographic systems for the identification, qualification, and quantification of related substances in Carfilzomib batches.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Process Chemistry Research: Aids in studying the degradation pathways and stability profile of Carfilzomib, helping to optimize synthesis and purification processes.
• Method Transfer & Validation: Serves as a system suitability and calibration standard during the transfer of analytical methods between laboratories or to manufacturing sites.

Basic Information

Product Name	Carfilzomib Impurity 56
CAS No.	1796585-29-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound 56; Carfilzomib EP Impurity 56; Carfilzomib USP Impurity 56; Carfilzomib Process Impurity; (S)-N-((S)-1-((S)-4-Methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)carbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide (Proposed IUPAC); Kyprolis Impurity 56; PR-171 Impurity 56
EINECS	Contact for details

Quality Control

Every batch of Carfilzomib Impurity 56 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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). This compound is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.