Description

Bortezomib Impurity 52 is a specified impurity of the proteasome inhibitor Bortezomib, a critical active pharmaceutical ingredient (API) used in cancer therapy. This high-purity reference standard is essential for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity during API synthesis and final drug product formulation. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial guidelines such as ICH Q3A/B.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the qualitative and quantitative analysis of Bortezomib and its related substances.
• Method Development & Validation: Critical for developing and validating robust analytical methods (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing of Bortezomib API and finished drug products to monitor impurity levels against ICH thresholds.
• Stability Studies: Employed to track the formation and growth of this impurity under various stress and shelf-life conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Bortezomib to minimize impurity formation.

Basic Information

Product Name	Bortezomib Impurity 52
CAS No.	87304-47-0
Molecular Formula	C19H25BN4O4
Molecular Weight	384.24 g/mol
Synonyms	Bortezomib Related Compound 52; Bortezomib EP Impurity B; Bortezomib USP Impurity; [(1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazinylcarbonyl)amino]propanoyl]amino]butyl]boronic Acid; Bortezomib Impurity B (EP); Velcade Impurity 52; PS-341 Impurity 52; LDP-341 Impurity 52
EINECS	Contact for details

Quality Control

Every batch of Bortezomib Impurity 52 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage under inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.