Description

Ibrutinib Impurity 30 is a specified organic impurity associated with 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, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ibrutinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ibrutinib API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and detect related substances.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Ibrutinib.

Basic Information

Product Name	Ibrutinib Impurity 30
CAS No.	1838132-94-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 30; Ibrutinib EP Impurity 30; Ibrutinib USP Impurity 30; Ibrutinib Process Impurity; PCI-32765 Impurity 30; (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
EINECS	Contact for details

Quality Control

Our Ibrutinib Impurity 30 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment supports your regulatory requirements for pharmaceutical development and quality control.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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