Description

Bortezomib Impurity 47 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the proteasome inhibitor Bortezomib. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical industry who require precise impurity profiling to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Bortezomib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Bortezomib, adhering to ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to track the formation of degradation products in Bortezomib formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates chemical and metabolic pathway studies related to Bortezomib, aiding in the understanding of its degradation chemistry.

Basic Information

Product Name	Bortezomib Impurity 47 Hcl
CAS No.	1158974-93-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bortezomib Related Compound 47 Hcl; Bortezomib EP Impurity 47 Hcl; Bortezomib USP Impurity 47 Hcl; Bortezomib Degradant 47 Hcl; Bortezomib Process Impurity 47 Hcl; (1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl]amino]butyl]boronic acid hydrochloride; Velcade Impurity 47 Hcl
EINECS	Contact for details

Quality Control

Our Bortezomib Impurity 47 Hcl is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is rigorously tested using validated analytical methods, including HPLC and LC-MS, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial standards (e.g., USP, EP) for impurity reference materials.

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 desiccant use.

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 limits

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