Description

Carfilzomib Impurity 13 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the proteasome inhibitor Carfilzomib during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in impurity profiling, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Carfilzomib Impurity 13 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels in accordance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure Carfilzomib drug substance and drug products meet stringent purity specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) as part of drug stability profiling.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research on Degradation Pathways: Facilitates research into the degradation mechanisms and pharmacokinetics of Carfilzomib.

Basic Information

Product Name	Carfilzomib Impurity 13 Hcl
CAS No.	1396006-45-3
Molecular Formula	C40H57N5O7 • HCl
Molecular Weight	740.38 g/mol (Free base: 703.91 g/mol)
Synonyms	Carfilzomib Related Compound 13 Hcl; Carfilzomib EP Impurity H Hcl; Carfilzomib USP Impurity HCL; (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-hydroxy-2-[[(2S)-2-[(2S)-2-(2-methoxyethoxy)propanamido]-4-phenylbutanamido]methyl]-5-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide Hydrochloride; UNII-8X6H8F8Q7H; Carfilzomib Impurity H Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Carfilzomib Impurity 13 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). 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 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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (Mass Spectrometry)	MS 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%
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.