Description

Ibrutinib Impurity 17 CAS NO 2134109-10-5 is a specified impurity of Ibrutinib, a targeted therapy used in oncology. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during manufacturing. Pharmaceutical companies, contract research organizations (CROs), and analytical laboratories require this high-purity impurity for rigorous regulatory compliance and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ibrutinib Impurity 17 in drug substance and drug product.
• Analytical Method Development & Validation: Crucial for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch analysis to ensure Ibrutinib API and finished products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) dossiers with agencies like the FDA and EMA.
• 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 17
CAS No.	2134109-10-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 17; Ibrutinib EP Impurity 17; Ibrutinib USP Impurity 17; PCI-32765 Impurity 17; (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; Ibrutinib Degradation Product; Ibrutinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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. Keep the container in a dry, cool, and well-ventilated place. 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)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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