Description

Bortezomib Impurity 60 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, specifically for method development, stability studies, and ensuring the quality and safety of the final drug product. It serves as a vital reference standard for analytical laboratories and manufacturers in the pharmaceutical industry who require high-purity chemical standards for rigorous quality control and regulatory compliance.

Application

• Primary use as a certified reference standard for the quantitative and qualitative analysis of Bortezomib.
• Critical component in analytical method development and validation (HPLC, LC-MS) for impurity profiling.
• Used in stability studies and forced degradation studies to identify and monitor potential degradation pathways of the Bortezomib API.
• Essential for quality control and assurance processes in pharmaceutical manufacturing to meet ICH guidelines.
• Serves as a key material in regulatory submissions (e.g., for FDA, EMA) to establish impurity thresholds and specifications.
• Valuable for research and development of synthetic routes and purification processes for Bortezomib.

Basic Information

Product Name	Bortezomib Impurity 60
CAS No.	2210228-73-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bortezomib Related Compound 60; Bortezomib EP Impurity 60; Bortezomib USP Impurity 60; Bortezomib Degradation Product; (1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl]amino]butyl]boronic acid (proposed); Velcade Impurity 60; PS-341 Impurity 60
EINECS	Contact for details

Quality Control

Every batch of Bortezomib Impurity 60 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature (15-25°C) or as indicated on the label or COA. The material may be hygroscopic and/or sensitive to oxidation; store under an inert atmosphere if necessary.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH guidelines

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