Description

Rizatriptan Impurity 1 is a high-purity reference standard critical for analytical and regulatory purposes in pharmaceutical development. This compound is essential for the identification, qualification, and quantification of process-related impurities in Rizatriptan Benzoate active pharmaceutical ingredient (API) batches. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as ICH Q3A and Q3B.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for method development and validation in HPLC and LC-MS analysis of Rizatriptan API.
• Quality Control & Assurance: Used as a system suitability standard and for routine batch release testing to monitor and control impurity levels.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to understand and optimize the Rizatriptan manufacturing process to minimize this impurity.

Basic Information

Product Name	Rizatriptan Impurity 1
CAS No.	1016900-24-5
Molecular Formula	C15H19N5
Molecular Weight	269.35 g/mol
Synonyms	1H-Indole-3-ethanamine, N-methyl-γ-(4H-1,2,4-triazol-4-yl)-; N-Methyl-2-[5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indol-3-yl]ethanamine; Desmethyl Rizatriptan; Rizatriptan Desmethyl Impurity; Rizatriptan Related Compound A; MK-0462 Impurity; 1016900-24-5
EINECS	Contact for details

Quality Control

Every batch of Rizatriptan Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, LC-MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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