Description

Ibrutinib Impurity 37 is a high-purity reference standard used for analytical and research purposes in the pharmaceutical industry. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Ibrutinib, a targeted therapy for certain B-cell malignancies. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for accurate quantification and control of this specific impurity during the drug manufacturing process.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Ibrutinib Impurity 37 in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor and control impurity levels, ensuring batches meet stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies & Forced Degradation: Acts as a marker to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Documentation & Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Utilized in academic and industrial research to study the chemical degradation mechanisms of Ibrutinib.

Basic Information

Product Name	Ibrutinib Impurity 37
CAS No.	330793-49-2
Molecular Formula	C25H24N6O2
Molecular Weight	440.50 g/mol
Synonyms	Ibrutinib Related Compound 37; PCI-32765 Impurity 37; (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; Imbruvica Impurity 37; 1H-Pyrazolo[3,4-d]pyrimidine, 4-amino-3-(4-phenoxyphenyl)-1-[(3R)-1-[(1R)-1-oxo-2-propen-1-yl]-3-piperidinyl]-; Ibrutinib EP Impurity G; Ibrutinib USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 37 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.