Description

Pirtobrutinib is a highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, representing a significant advancement in targeted cancer therapy. This compound matters for its potential to overcome resistance associated with earlier-generation covalent BTK inhibitors, offering a new therapeutic strategy for patients with B-cell malignancies. It is primarily needed by pharmaceutical research and development organizations, clinical trial sponsors, and advanced manufacturers focused on innovative oncology treatments. Pirtobrutinib CAS NO 2101700-15-4 is a critical intermediate and reference standard in the development and quality control of novel anticancer pharmaceuticals.

Application

• Pharmaceutical Active Ingredient (API): Serves as the core active pharmaceutical ingredient in the formulation of finished dosage forms for clinical and commercial use.
• Oncology Research & Development: Used as a key reference compound in preclinical and clinical studies targeting B-cell cancers such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia.
• Biochemical Assay Standard: Employed as a precise standard in enzymatic and cellular assays to study BTK inhibition kinetics, potency, and selectivity profiles.
• Drug Resistance Studies: Critical for research programs investigating mechanisms of resistance to covalent BTK inhibitors and developing next-generation therapeutic strategies.
• Analytical Reference Standard: Essential for HPLC, LC-MS, and NMR methods used in identity confirmation, purity assessment, and impurity profiling during API and drug product manufacturing.
• Process Chemistry & Scale-Up: Used as an intermediate and target molecule in the development, optimization, and validation of synthetic routes for commercial-scale production.

Basic Information

Product Name	Pirtobrutinib
CAS No.	2101700-15-4
Molecular Formula	C23H23FN6O2
Molecular Weight	434.47 g/mol
Synonyms	LOXO-305; (S)-5-Amino-3-(4-((5-fluoro-2-methoxy-4-((1-methyl-1H-pyrazol-4-yl)amino)phenyl)amino)pyrimidin-2-yl)piperidine-1-carboxamide; LY3527727; Jaypirca (Brand Name); BTK Inhibitor LOXO-305; Non-covalent BTK Inhibitor
EINECS	Contact for details

Quality Control

Our Pirtobrutinib is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) detailing specifications such as assay (HPLC), chiral purity, and impurity profiles are provided with every shipment. We adhere to cGMP principles where applicable to support our clients' regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator after opening to maintain stability and purity. Keep away from incompatible materials.

Specification

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

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