Description

Ibudilast Impurity CAS NO 101162-42-9 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ibudilast. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories for method development, validation, and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Identification in Ibudilast API and finished drug products.
• Analytical Method Development and Validation (HPLC, UPLC, GC) for accurate quantification of related substances.
• Quality Control and Batch Release Testing to ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies to monitor impurity formation under various stress conditions.
• Regulatory Submissions as a characterized reference material for drug master files (DMFs) and new drug applications (NDAs).
• Research and Development of synthetic pathways and purification processes for Ibudilast.

Basic Information

Item	Details
Product Name	Ibudilast Impurity
CAS No.	101162-42-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibudilast Related Compound; Ibudilast Process Impurity; 3-Isobutyryl-2-isopropylpyrazolo[1,5-a]pyridine; KN-127 Impurity; AV-411 Impurity; Ibudilast Degradant; Ibudilast Specified Impurity
EINECS	Contact for details

Quality Control

Our Ibudilast Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with detailed chromatographic data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.