Description

3,4-Dihydro Naratriptan (Naratriptan Impurity B) is a key chemical reference standard and impurity used in the pharmaceutical development and quality control of Naratriptan, a medication for migraine treatment. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of Naratriptan API and its related substances.
• Impurity Profiling & Control: Essential for identifying, quantifying, and monitoring Naratriptan Impurity B in drug substances and finished products to comply with ICH guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for purity assays.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and ensure product shelf-life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry research to study the metabolism and degradation pathways of Naratriptan.

Basic Information

Product Name	3,4-Dihydro Naratriptan (Naratriptan Impurity B)
CAS No.	121679-20-7
Molecular Formula	C17H25N3O2S
Molecular Weight	335.46 g/mol
Synonyms	Naratriptan Impurity B; 3,4-Dihydronaratriptan; 5-Methyl-2-[[(2S)-1-methyl-2-pyrrolidinyl]methyl]-N-methyl-2,3,4,9-tetrahydro-1H-carbazole-6-carboxamide; 1H-Carbazole-6-carboxamide, 2,3,4,9-tetrahydro-5-methyl-2-[[(2S)-1-methyl-2-pyrrolidinyl]methyl]-N-methyl-; (S)-5-Methyl-2-((1-methylpyrrolidin-2-yl)methyl)-N-methyl-2,3,4,9-tetrahydro-1H-carbazole-6-carboxamide
EINECS	Contact for details

Quality Control

Our 3,4-Dihydro Naratriptan is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability, batch-to-batch consistency, and compliance with relevant pharmacopeial expectations.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.