Description

Ibrutinib Impurity 21 is a specified impurity associated with the active pharmaceutical ingredient Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor. This compound is critical 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 certified reference standard for the identification and quantification of impurities in Ibrutinib API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical R&D and quality control laboratories.
• Critical component in stability studies and impurity profiling to monitor degradation pathways of Ibrutinib.
• Used for regulatory compliance and filing, providing necessary data for drug master files (DMFs) and regulatory submissions (e.g., FDA, EMA).
• Serves as a research tool in pharmacokinetic and metabolic studies to understand the fate of related substances.
• Supports quality assurance programs by establishing specification limits and ensuring batch-to-batch consistency.

Basic Information

Product Name	Ibrutinib Impurity 21
CAS No.	1642571-08-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 21; Ibrutinib Impurity C; PCI-32765 Impurity 21; (R)-1-((3R)-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 21; Ibrutinib Process Impurity; Ibrutinib Degradant
EINECS	Contact for details

Quality Control

Our Ibrutinib Impurity 21 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment supports compliance with ICH Q3A/B guidelines and cGMP standards 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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.