Description

Riluzole Hydrochloride is the hydrochloride salt form of riluzole, a benzothiazole derivative with significant pharmacological activity. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for neurological disorders.

Application

• Primary Pharmaceutical Ingredient: As the active substance in the formulation of oral tablets and other dosage forms for the treatment of amyotrophic lateral sclerosis (ALS).
• Neurological Research: Used as a reference standard and investigational compound in preclinical and clinical studies targeting glutamate-mediated excitotoxicity.
• Generic Drug Manufacturing: Serves as the key API for companies producing generic versions of riluzole-based medications.
• Analytical Development: Employed as a high-purity standard for method development and validation in quality control laboratories (HPLC, LC-MS).
• Formulation Development: Used in R&D for developing new drug delivery systems, such as sustained-release formulations.

Basic Information

Product Name	Riluzole Hydrochloride
CAS No.	850608-87-6
Molecular Formula	C8H5F3N2OS • HCl
Molecular Weight	270.65 g/mol
Synonyms	2-Amino-6-(trifluoromethoxy)benzothiazole Hydrochloride; Riluzole HCl; RP 54274; PK 26124; Rilutek (Hydrochloride Salt); 6-Trifluoromethoxy-2-benzothiazolamine Hydrochloride; Benzo[d]thiazol-2-amine, 6-(trifluoromethoxy)-, hydrochloride
EINECS	Contact for details

Quality Control

Our Riluzole Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) documenting compliance with relevant pharmacopeial standards (such as USP/EP) are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

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

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