Description

Rizatriptan Impurity B is a high-purity reference standard critical for analytical research and development in the pharmaceutical industry. This compound is essential for the identification, qualification, and control of potential impurities in Rizatriptan Benzoate active pharmaceutical ingredient (API) and its finished drug products. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Rizatriptan Benzoate.
• Impurity Profiling & Method Development: Used in the development and validation of analytical methods, such as HPLC and UPLC, for impurity identification and quantification.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control the levels of specified impurities, ensuring API and drug product quality.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to track impurity formation in stability testing of Rizatriptan formulations under various stress conditions.
• Research & Development: Supports synthetic route optimization and process chemistry studies by identifying and quantifying process-related impurities.

Basic Information

Product Name	Rizatriptan Impurity B
CAS No.	1016900-28-9
Molecular Formula	C15H19N5
Molecular Weight	269.35 g/mol
Synonyms	1H-Indole-3-ethanamine, N-methyl-5-(1H-1,2,4-triazol-1-ylmethyl)-; N-Methyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine; Desmethyl Rizatriptan; Rizatriptan Desmethyl Impurity; Rizatriptan Related Compound B; MK-0462 Impurity B
EINECS	Contact for details

Quality Control

Every batch of Rizatriptan Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
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.