Description

Zolmitriptan Related Compound B (20 Mg) ((S)-2-Amino-3-{3-[2-(Dimethylamino)Ethyl]-1H-Indol-5-Yl}Propan-1-Ol) is a high-purity reference standard and pharmaceutical intermediate critical for analytical and research purposes. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Zolmitriptan through rigorous impurity profiling and method validation. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. Our product is supplied with comprehensive documentation to support your compliance and research needs.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Zolmitriptan API and finished dosage forms according to ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for purity analysis.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to monitor the formation of specific impurities under various stress conditions.
• Quality Control (QC) Testing: Integral for routine batch release testing in pharmaceutical QC laboratories to ensure API and drug product specifications are met.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research for studying metabolic pathways, degradation mechanisms, and the synthesis of novel analogs.

Basic Information

Product Name	Zolmitriptan Related Compound B (20 Mg) ((S)-2-Amino-3-{3-[2-(Dimethylamino)Ethyl]-1H-Indol-5-Yl}Propan-1-Ol)
CAS No.	139264-69-0
Molecular Formula	C15H23N3O
Molecular Weight	261.36 g/mol
Synonyms	(S)-2-Amino-3-(3-[2-(dimethylamino)ethyl]-1H-indol-5-yl)propan-1-ol; Zolmitriptan Impurity B; Zolmitriptan Related Substance B; Zolmitriptan EP Impurity B; Zolmitriptan USP Related Compound B; (S)-3-(3-(2-(Dimethylamino)ethyl)-1H-indol-5-yl)-2-aminopropan-1-ol; 5-[(1S)-2-Amino-1-(hydroxymethyl)ethyl]-3-[2-(dimethylamino)ethyl]-1H-indole
EINECS	Contact for details

Quality Control

Every batch of Zolmitriptan Related Compound B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing to ensure compliance with pharmaceutical-grade standards, including those referenced in pharmacopeial monographs (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles as determined by validated methods such as HPLC, NMR, and MS. Certificates are available upon request and can be tailored to support specific regulatory requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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