Description

Orelabrutinib CAS NO 1655504-04-3 is a highly selective, irreversible small-molecule inhibitor of Bruton's tyrosine kinase (BTK). This compound is of significant value in pharmaceutical research and development for its targeted mechanism of action. It is primarily needed by pharmaceutical companies, biotechnology firms, and advanced research institutions engaged in the development of novel therapeutics for B-cell malignancies and autoimmune disorders.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in the formulation of finished drug products for the treatment of B-cell cancers.
• Oncology Research: Critical research tool for studying BTK signaling pathways, tumor proliferation, and apoptosis in diseases like chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia.
• Autoimmune Disease R&D: Investigation into therapeutic applications for autoimmune conditions such as rheumatoid arthritis and lupus, where B-cell modulation is a key target.
• Preclinical & Clinical Development: Serves as a key candidate in preclinical animal studies and human clinical trials to establish safety, efficacy, and dosage parameters.
• Reference Standard: Used as a high-purity analytical reference standard in quality control laboratories for method development, validation, and batch testing.
• Combinatorial Therapy Studies: Research into synergistic effects when combined with other anticancer agents or immunomodulators.

Basic Information

Product Name	Orelabrutinib
CAS No.	1655504-04-3
Molecular Formula	C₂₇H₂₈N₆O₂
Molecular Weight	468.55 g/mol
Synonyms	ICP-022; ICP022; (S)-6-Amino-9-(4-(1-(but-2-ynoyl)pyrrolidin-2-yl)phenyl)-8-(4-(morpholinomethyl)phenyl)-9H-purin-2-ol; (S)-6-Amino-9-(4-(1-(but-2-ynoyl)pyrrolidin-2-yl)phenyl)-8-(4-(morpholin-4-ylmethyl)phenyl)-9H-purin-2-ol; Orelabrutinibum; Orelabrutinib (USAN); BTK Inhibitor ICP-022
EINECS	Contact for details

Quality Control

Our Orelabrutinib is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and potency meet the highest standards for pharmaceutical intermediates and APIs. Certificates of Analysis (COA) are provided, detailing results from tests including HPLC assay, chiral purity, related substances, residual solvents, and heavy metals. We support development with GMP-grade material where required.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (anhydrous basis)
Chiral Purity (HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

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