Description

Ibrutinib Impurity CAS NO 936351-48-3 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ibrutinib. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Ibrutinib API and related drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately detect and quantify this specific impurity.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines in commercial drug substance batches.
• Stability Studies: Used to identify and track the formation of degradation products in Ibrutinib under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during the synthesis of Ibrutinib.

Basic Information

Product Name	Ibrutinib Impurity
CAS No.	936351-48-3
Molecular Formula	C25H24N6O2
Molecular Weight	440.50 g/mol
Synonyms	Ibrutinib Related Compound; Ibrutinib Impurity Standard; PCI-32765 Impurity; 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one; (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one; BTK Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity (CAS 936351-48-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

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. The material should be kept in a dry environment. 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 standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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