Description

Bortezomib Impurity 69 is a designated impurity standard used in the analytical profiling and quality control of the proteasome inhibitor Bortezomib. This compound is critical for pharmaceutical development and manufacturing, enabling precise identification, quantification, and control of this specific impurity to ensure drug safety and efficacy. It is an essential reference material for analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Bortezomib Impurity 69 in active pharmaceutical ingredient (API) batches.
• Method Development & Validation: Used in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Bortezomib.
• Quality Control & Release Testing: Critical for routine QC testing to monitor impurity levels and ensure Bortezomib API complies with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Bortezomib synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Bortezomib Impurity 69
CAS No.	1255646-95-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bortezomib Related Compound 69; Bortezomib EP Impurity 69; Bortezomib USP Impurity 69; Bortezomib Process Impurity 69; (1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl]amino]butyl]boronic acid (tentative); Velcade Impurity 69; MLN-341 Impurity 69
EINECS	Contact for details

Quality Control

Every batch of Bortezomib Impurity 69 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. 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 under inert conditions or in a desiccator to maintain stability and purity. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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