Description

Bortezomib Impurity H 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, quality control, and regulatory compliance. It is primarily required by analytical laboratories, API manufacturers, and regulatory bodies involved in the synthesis, purification, and validation of Bortezomib to ensure product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Bortezomib Impurity H 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.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Bortezomib API and finished products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding and optimizing the Bortezomib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Bortezomib Impurity H
CAS No.	1446194-56-4
Molecular Formula	C19H25BN4O4
Molecular Weight	384.24 g/mol
Synonyms	[(1R)-3-Methyl-1-[[(2S)-3-phenyl-2-[(pyrazinylcarbonyl)amino]propanoyl]amino]butyl]boronic Acid; Bortezomib Related Compound H; Bortezomib EP Impurity H; Bortezomib USP Impurity H; Velcade Impurity H; LDP-341 Impurity H; PS-341 Impurity H
EINECS	Contact for details

Quality Control

Every batch of Bortezomib Impurity H is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical impurity supply, with testing typically including HPLC purity, related substances, and spectroscopic confirmation (NMR, MS). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.