Description

Acalabrutinib Metabolite 27 is a key pharmacologically relevant metabolite of the active pharmaceutical ingredient Acalabrutinib, a potent and selective Bruton's tyrosine kinase (BTK) inhibitor. This compound is of critical importance for pharmaceutical research and development, particularly in the areas of drug metabolism and pharmacokinetics (DMPK) studies and bioanalytical method development. It is an essential reference standard for scientists in pharmaceutical companies and contract research organizations (CROs) who require high-purity materials to ensure the accuracy and reliability of their analytical data.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Acalabrutinib and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance rates, and exposure levels of Acalabrutinib in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Critical for developing, calibrating, and validating sensitive LC-MS/MS or HPLC methods to support regulatory submissions.
• Impurity Profiling and Characterization: Employed to identify, quantify, and monitor this specific metabolite as a potential impurity in Acalabrutinib drug substance and product.
• Toxicology and Safety Assessment: Used in studies to understand the safety profile and potential toxicological implications of the metabolite.

Basic Information

Product Name	Acalabrutinib Metabolite 27
CAS No.	2230757-47-6
Molecular Formula	C26H23N7O2
Molecular Weight	465.51 g/mol
Synonyms	ACP-196 Metabolite 27; (S)-4-(8-Amino-3-(1-(but-2-ynoyl)piperidin-4-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide; Acalabrutinib Carboxylic Acid Metabolite; ACP-196M27; BDBM50403279; HY-135992.
EINECS	Contact for details

Quality Control

Our Acalabrutinib Metabolite 27 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, LC-MS identification, and NMR confirmation to ensure structural integrity and high chemical purity suitable for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the exact specifications and test results for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under inert atmosphere for long-term stability. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
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.