Description

Bortezomib Impurity 57 is a specified 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 method development, validation, and quality control to ensure the purity and safety of the final drug product. It is primarily required by analytical laboratories, quality control units, and R&D departments within pharmaceutical and biotech companies engaged in the manufacture or generic development of Bortezomib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bortezomib Impurity 57 in drug substance and drug product batches.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles throughout the drug's shelf life.
• Quality Control & Assurance: Employed in routine QC testing to ensure Bortezomib API and finished formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Bortezomib to minimize the formation of this impurity.

Basic Information

Product Name	Bortezomib Impurity 57
CAS No.	1194235-28-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bortezomib Related Compound 57; Bortezomib EP Impurity G; Bortezomib USP Impurity; (1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazinylcarbonyl)amino]propanoyl]amino]butyl]boronic acid (proposed); Velcade Impurity 57; PS-341 Impurity 57; MLN341 Impurity 57
EINECS	Contact for details

Quality Control

Every batch of Bortezomib Impurity 57 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and MS to ensure compliance with pharmacopeial standards and customer specifications. 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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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