Description

Lorlatinib Acetate CAS NO 1924207-18-0 is the acetate salt form of Lorlatinib, a potent and selective third-generation anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinase inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted cancer therapeutics. It is primarily required by pharmaceutical companies and research institutions engaged in oncology drug development, clinical trials, and advanced formulation studies for non-small cell lung cancer (NSCLC) and other malignancies.

Application

• Pharmaceutical API: Serves as the core active ingredient in the formulation of finished dosage forms, such as tablets, for targeted cancer therapy.
• Oncology Research: Used as a critical reference standard and biochemical tool in preclinical studies to investigate ALK and ROS1 signaling pathways and mechanisms of drug resistance.
• Clinical Trial Material (CTM): Manufactured under GMP conditions for use in Phase I-III clinical trials evaluating the safety and efficacy of Lorlatinib-based treatments.
• Drug Development Intermediates: Employed in the synthesis and scale-up processes for developing next-generation kinase inhibitors and combination therapies.
• Analytical Standard: Provides a high-purity benchmark for quality control (QC) and analytical method development (e.g., HPLC, LC-MS) in pharmaceutical laboratories.

Basic Information

Product Name	Lorlatinib Acetate
CAS No.	1924207-18-0
Molecular Formula	C23H25FN6O2 • C2H4O2
Molecular Weight	528.57 g/mol
Synonyms	PF-06463922 Acetate; Lorlatinib Acetate Salt; (10R)-7-Amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile Acetate; Lorviqua® API (Acetate Salt); ALK/ROS1 Inhibitor (Acetate)
EINECS	Contact for details

Quality Control

Our Lorlatinib Acetate is manufactured and tested under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) is provided with each shipment, detailing compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support GMP and DMF requirements for advanced regulatory filings.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%

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