Description

Ibrutinib Impurity 27 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ibrutinib. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical development, quality assurance, and regulatory affairs for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Ibrutinib API and related drug products.
• Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Batch Release: Used in routine QC testing to confirm impurity levels are within specified limits as per ICH guidelines.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Item	Details
Product Name	Ibrutinib Impurity 27
CAS No.	2031255-26-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 27; Ibrutinib EP Impurity G; Ibrutinib USP Impurity; (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; Acalabrutinib Impurity; BTK Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profile are 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
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.