Description

Rizatriptan Ep Impurity A is a high-purity reference standard specifically identified as an impurity of Rizatriptan Benzoate. This compound is critical for pharmaceutical research and development, serving as a key marker for quality control and regulatory compliance in the production of the active pharmaceutical ingredient (API). It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and batch release testing to ensure drug safety and efficacy.

Application

• Primary use as a pharmaceutical reference standard for impurity identification and quantification.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Rizatriptan Benzoate API.
• Essential for quality control and batch release testing in API manufacturing to meet ICH guidelines.
• Used in stability studies to monitor impurity profiles over time.
• Serves as a system suitability standard in regulatory submissions (e.g., to FDA, EMA).
• Valuable for research and development of generic formulations of Rizatriptan.

Basic Information

Product Name	Rizatriptan Ep Impurity A
CAS No.	887001-08-3
Molecular Formula	C15H19N5
Molecular Weight	269.35 g/mol
Synonyms	Rizatriptan Impurity A; Rizatriptan EP Impurity A; (R)-2-[3-(1H-1,2,4-Triazol-1-ylmethyl)-1H-indol-5-yl]-N,N-dimethylethanamine; N,N-Dimethyl-2-[3-[(1H-1,2,4-triazol-1-yl)methyl]-1H-indol-5-yl]ethanamine; Rizatriptan Related Compound A; MK-0462 Impurity A
EINECS	Contact for details

Quality Control

Every batch of Rizatriptan Ep Impurity A is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with pharmacopeial standards (EP/ USP). A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment and is available upon request.

Storage

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

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)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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