Description

Larotrectinib Sulfate is a highly selective and potent small-molecule inhibitor of the tropomyosin receptor kinase (TRK) family. This precision oncology compound is specifically designed to target tumors harboring NTRK gene fusions, offering a transformative therapeutic approach. It is a critical active pharmaceutical ingredient (API) for the development and manufacture of targeted cancer therapies, primarily serving the global pharmaceutical and biotechnology research sectors.

Application

• Primary Active Pharmaceutical Ingredient (API) for the formulation of solid oral dosage forms (e.g., capsules).
• Key intermediate in advanced pharmaceutical research and development of TRK inhibitor therapies.
• Reference standard for analytical method development and validation in quality control laboratories.
• Biochemical research tool for studying TRK signaling pathways and mechanisms of oncogenesis.
• Manufacturing of clinical trial supplies for investigational new drug (IND) applications.
• Pre-clinical development of novel drug combinations involving TRK inhibition.

Basic Information

Product Name	Larotrectinib Sulfate
CAS No.	1223405-08-0
Molecular Formula	C21H22F2N6O2 • H2SO4
Molecular Weight	548.52 g/mol
Synonyms	LOXO-101 Sulfate; ARRY-470 Sulfate; Vitrakvi (Brand Name API); (3S)-N-[5-[(2R)-2-(2,5-Difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-1-pyrrolidinecarboxamide Sulfate; TRK Inhibitor LOXO-101 Sulfate; Larotrectinib Hydrogen Sulfate; UNII-8R5MQZ6K1O (Sulfate)
EINECS	Contact for details

Quality Control

Our Larotrectinib Sulfate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure identity, purity, and strength conform to stringent specifications. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with relevant pharmacopeial standards and in-house specifications developed for pharmaceutical API use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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