Description

Rizatriptan Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Rizatriptan Benzoate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of specified impurities in Rizatriptan Benzoate API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to separate and detect process-related impurities.
• Stability Studies: Employed to monitor the formation of degradation products in Rizatriptan formulations under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development (R&D): Used in pharmaceutical R&D to study the synthesis pathways, degradation mechanisms, and physicochemical properties of Rizatriptan and its related substances.
• Pharmacopeial Testing: Applied as a reference standard for testing against monographs in pharmacopeias such as USP, EP, or BP, ensuring batch-to-batch consistency.

Basic Information

Product Name	Rizatriptan Impurity 4
CAS No.	6085-99-0
Molecular Formula	C15H19N5
Molecular Weight	269.35 g/mol
Synonyms	1H-Indole-3-ethanamine, N-methyl-α-(methylamino)-, (αR)-; (R)-N-Methyl-2-[methyl(1-methyl-1H-indol-5-yl)amino]ethanamine; Rizatriptan Related Compound D; Rizatriptan EP Impurity D; Rizatriptan USP Related Compound D; MK-0462 Impurity D; 3-[2-(Methylamino)propyl]-1H-indole-5-carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Rizatriptan Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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