Description

Carfilzomib Impurity 5 Tfa Salt is a high-purity reference standard specifically used in the analytical profiling and quality control of the proteasome inhibitor Carfilzomib. This compound is critical for pharmaceutical development and manufacturing, enabling precise identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology sectors who require reliable standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Carfilzomib Impurity 5 in active pharmaceutical ingredient (API) batches.
• Method Development & Validation: Crucial for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling in Carfilzomib drug substance and drug products.
• Quality Control (QC) & Quality Assurance (QA): Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Carfilzomib.
• Research & Development: Used in process chemistry R&D to optimize synthesis routes and minimize the formation of this specific impurity.

Basic Information

Product Name	Carfilzomib Impurity 5 Tfa Salt
CAS No.	1545469-02-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carfilzomib Related Compound 5 TFA Salt; Carfilzomib EP Impurity 5; Carfilzomib USP Impurity 5; (2S)-N-[(2S)-1-[[(2S)-4-Methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-4-phenyl-1-oxobutan-2-yl]-2-[(2S)-2-(2,5-dioxopyrrolidin-1-yl)-4-phenylbutanamido]-4-methylpentanamide Trifluoroacetate Salt
EINECS	Contact for details

Quality Control

Our Carfilzomib Impurity 5 Tfa Salt is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

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 desiccants or inert atmosphere to preserve stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
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.