Description

Bortezomib Impurity 32 is a designated impurity of the proteasome inhibitor Bortezomib, a critical active pharmaceutical ingredient (API) used in cancer therapy. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of Bortezomib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bortezomib API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Bortezomib meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids in understanding and optimizing the Bortezomib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Bortezomib Impurity 32
CAS No.	1310383-72-2
Molecular Formula	C19H25BN4O4
Molecular Weight	384.24 g/mol
Synonyms	Bortezomib Related Compound 32; Bortezomib EP Impurity B; Bortezomib USP Impurity; [(1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazinylcarbonyl)amino]propanoyl]amino]butyl]boronic Acid; Boronic acid, [(1R)-3-methyl-1-[[(2S)-3-phenyl-2-[(pyrazinylcarbonyl)amino]-1-oxopropyl]amino]butyl]-; Bortezomib Impurity B (EP); Bortezomib Impurity (EP)
EINECS	Contact for details

Quality Control

Our Bortezomib Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and structural confirmation (NMR, MS), to ensure identity, purity, and consistency. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary reference standards. Our quality commitment aligns with ICH guidelines and supports compliance with cGMP 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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.