Description

Ibrutinib Impurity 6 (CAS NO 1987905-93-0) is a specified impurity associated with the active pharmaceutical ingredient Ibrutinib, a critical Bruton's tyrosine kinase (BTK) inhibitor. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ibrutinib drug substances and products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Ibrutinib API and finished dosage forms.
• Critical for analytical method development and validation (HPLC, UPLC, LC-MS) in compliance with ICH guidelines.
• Used in stability studies to monitor impurity profiles and degradation pathways of Ibrutinib under various conditions.
• Essential for quality control and batch release testing in pharmaceutical manufacturing to meet regulatory specifications.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing characterized impurity data to health authorities like the FDA and EMA.
• Valuable for research and development of Ibrutinib synthesis processes to understand and control impurity formation.

Basic Information

Product Name	Ibrutinib Impurity 6
CAS No.	1987905-93-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 6; Ibrutinib EP Impurity 6; Ibrutinib USP Impurity 6; Ibrutinib Process Impurity; BTK Inhibitor Impurity; PCI-32765 Impurity 6; (S)-1-((R)-3-(4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one Impurity
EINECS	Contact for details

Quality Control

Our Ibrutinib Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles where applicable, supporting regulatory compliance for our global clientele.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0%; Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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