Description

Ixazomib Impurity 8 is a specified impurity of the active pharmaceutical ingredient Ixazomib, a proteasome inhibitor used in oncology therapeutics. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for scientists and quality assurance professionals in the pharmaceutical and biotechnology industries who require high-purity chemical standards to ensure drug safety and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for the analysis of Ixazomib drug substance and drug products.
• Critical component in analytical method development and validation (HPLC, LC-MS) for impurity profiling.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Ixazomib.
• Essential for quality control (QC) and quality assurance (QA) laboratories to monitor and control impurity levels.
• Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity material for identification and qualification.
• Valuable for research and development of synthetic routes and process optimization for Ixazomib manufacturing.

Basic Information

Product Name	Ixazomib Impurity 8
CAS No.	1378314-08-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ixazomib Related Compound 8; Ixazomib EP Impurity 8; Ixazomib USP Impurity 8; MLN9708 Impurity 8; (1R)-1-[[(2S)-3-Methyl-1-[[(2R)-2-methyloxiran-2-yl]carbonyl]amino]butyl]boronic acid impurity; Ixazomib Process Impurity 8
EINECS	Contact for details

Quality Control

Our Ixazomib Impurity 8 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile. We adhere to relevant ICH guidelines for impurity characterization, and our quality commitment aligns with standards expected for pharmaceutical development.

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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment. For long-term storage, consider storing under an 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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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