Description

Riluzole 4-Bromo Impurity is a critical pharmaceutical reference standard and impurity used in the development and quality control of the drug Riluzole. This compound is essential for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a marker for specific synthetic pathways. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of Riluzole and its related substances.
• Impurity Profiling: Critical for identifying, monitoring, and controlling the 4-bromo derivative as a process-related impurity or degradation product in Riluzole API batches.
• Method Development & Validation: Serves as a key component in developing and validating analytical methods, such as HPLC and LC-MS, for Riluzole purity assessment.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Riluzole.
• Regulatory Compliance & Filing: Necessary for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Research & Development: Used in synthetic chemistry research to study the metabolism and pharmacokinetics of Riluzole and its analogs.

Basic Information

Product Name	Riluzole 4-Bromo Impurity
CAS No.	144631-82-3
Molecular Formula	C8H5BrF3N3OS
Molecular Weight	328.11 g/mol
Synonyms	4-Bromo Riluzole; 2-Amino-6-(4-bromobenzothiazol-2-ylamino)pyrimidin-4(1H)-one; 6-(6-Bromo-1,3-benzothiazol-2-ylamino)-2,4-pyrimidinedione; Riluzole Bromo Impurity; Riluzole Related Compound B; Riluzole Impurity B; 6-((6-Bromobenzo[d]thiazol-2-yl)amino)pyrimidine-2,4(1H,3H)-dione; 144631-82-3
EINECS	Contact for details

Quality Control

Our Riluzole 4-Bromo Impurity is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch is subjected to comprehensive testing including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality commitment ensures the material is suitable for use as a reference standard in regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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