Description

Ixazomib Impurity 1 is a specified impurity of Ixazomib, a proteasome inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, quality control, and regulatory compliance. It is essential for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries who are involved in the synthesis, purification, and characterization of Ixazomib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ixazomib Impurity 1 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in Ixazomib drug substance and drug products.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Ixazomib meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, specifications, and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the Ixazomib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Ixazomib Impurity 1
CAS No.	1201903-02-7
Molecular Formula	C20H23B2N3O5
Molecular Weight	407.04 g/mol
Synonyms	Ixazomib Related Compound 1; MLN9708 Impurity 1; (1R)-1-[[(2S)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-1-[[(1R,2R)-2-[[(2,5-dioxo-1-pyrrolidinyl)oxy]carbonyl]cyclopentyl]amino]-2-butanyl]amino]-1-oxo-2-butanyl]amino]-3-methyl-1-oxo-2-butanyl]boronic acid; (1R)-1-({(2S)-3-Methyl-1-[(2S)-1-oxo-3-phenyl-1-{[(1R,2R)-2-({[(2,5-dioxopyrrolidin-1-yl)oxy]carbonyl})cyclopentyl]amino}butan-2-yl]amino]-1-oxobutan-2-yl}amino)-3-methyl-1-oxobutan-2-ylboronic acid; Boronic acid, B-[(1R)-1-[[[(1S)-2-methyl-1-[[(2S)-1-oxo-3-phenyl-1-[[(1R,2R)-2-[[(2,5-dioxo-1-pyrrolidinyl)oxy]carbonyl]cyclopentyl]amino]-2-butanyl]amino]propyl]amino]-3-methyl-1-oxo-2-butanyl]-
EINECS	Contact for details

Quality Control

Our Ixazomib Impurity 1 is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for pharmaceutical analysis. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided and aligns with ICH Q3A/B guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, consider storing under an inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.