Description

Zanubrutinib CAS NO 1691249-45-2 is a highly selective, irreversible small-molecule inhibitor of Bruton's tyrosine kinase (BTK), representing a significant advancement in targeted cancer therapy. Its optimized pharmacokinetic profile offers improved selectivity and reduced off-target effects, making it a critical active pharmaceutical ingredient (API) for the development of next-generation oncology treatments. This compound is essential for pharmaceutical manufacturers and research institutions focused on hematologic malignancies, including mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral oncology drugs for the treatment of B-cell malignancies.
• Clinical Research: Critical reference standard and investigational compound in preclinical and clinical trials for novel BTK inhibitor therapies.
• Drug Development: Used in the R&D of combination therapies and new dosage forms to improve patient outcomes and treatment regimens.
• Biochemical Research: Tool compound for studying B-cell receptor signaling pathways and BTK-mediated disease mechanisms in academic and institutional labs.
• GMP Manufacturing: Sourced by contract development and manufacturing organizations (CDMOs) for the commercial-scale production of finished dosage forms.
• Regulatory Submissions: Serves as the characterized drug substance for regulatory filings (e.g., DMF, CMC sections) with agencies like the FDA and EMA.

Basic Information

Product Name	Zanubrutinib
CAS No.	1691249-45-2
Molecular Formula	C₂₇H₂₉N₅O₃
Molecular Weight	471.55 g/mol
Synonyms	BGB-3111; Zanubrutinib; (S)-7-(1-Acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,7-dihydro-5H-pyrazolo[1,5-a]pyrimidine-6-carboxamide; BGB3111; Brukinsa (Brand Name); BTK Inhibitor BGB-3111; (S)-2-(4-Phenoxyphenyl)-7-(1-acryloylpiperidin-4-yl)-4,7-dihydro-5H-pyrazolo[1,5-a]pyrimidine-6-carboxamide
EINECS	Contact for details

Quality Control

Our Zanubrutinib is manufactured under strict quality management systems, ensuring it meets the stringent requirements for pharmaceutical active ingredients. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to ICH guidelines for stability and impurity qualification, and our quality systems are designed to support regulatory submissions for markets globally.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is hygroscopic (moisture-sensitive); ensure containers are sealed immediately after use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.10%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm
Residue on Ignition	≤ 0.1%

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