Description

Bortezomib Impurity 9 is a specified impurity and degradation product of the proteasome inhibitor Bortezomib, a critical active pharmaceutical ingredient (API). This compound is essential for pharmaceutical research and development, serving as a key reference standard for method development, stability studies, and quality control testing. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure the purity, safety, and efficacy of Bortezomib-based drug products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Bortezomib API and finished drug products.
• Critical for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Utilized in stability and forced degradation studies to understand the degradation pathways of Bortezomib.
• Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles as per ICH guidelines.
• Used in research and development to study the chemical and metabolic behavior of Bortezomib-related substances.
• Acts as a calibration standard for ensuring the accuracy and precision of impurity assays.

Basic Information

Product Name	Bortezomib Impurity 9
CAS No.	1194235-41-0
Molecular Formula	C19H25BN4O4
Molecular Weight	384.24 g/mol
Synonyms	Bortezomib Related Compound 9; Bortezomib EP Impurity B; Bortezomib USP Impurity; [(1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazinylcarbonyl)amino]propanoyl]amino]butyl]boronic Acid; Bortezomib Degradation Product; Bortezomib Process Impurity; PS-341 Impurity 9; MLN-341 Impurity 9
EINECS	Contact for details

Quality Control

Every batch of Bortezomib Impurity 9 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis, to ensure compliance with pharmacopeial standards (USP/EP) and internal specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

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 prevent degradation. For long-term storage, consider storing at 2-8°C.

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 unknown 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.