Description

Ibrutinib Impurity 18 is a designated impurity of the active pharmaceutical ingredient (API) 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, contract research organizations (CROs), and analytical laboratories involved in the production and regulatory compliance of Ibrutinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ibrutinib Impurity 18 in drug substance and drug product.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and analyze impurities in Ibrutinib API.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Ibrutinib formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Ibrutinib to minimize the formation of this impurity.

Basic Information

Product Name	Ibrutinib Impurity 18
CAS No.	1881246-01-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	PCI-32765 Impurity 18; Ibrutinib Related Compound 18; (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 Impurity; BTK Inhibitor Impurity 18; Ibrutinib EP Impurity G; Ibrutinib USP Related Compound
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 and handled under inert conditions if specified.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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