Description

Almotriptan Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Almotriptan. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of migraine therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Almotriptan API and its formulations.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure API batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of Almotriptan.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of the Almotriptan molecule.

Basic Information

Product Name	Almotriptan Impurity 2
CAS No.	334981-14-5
Molecular Formula	C₁₇H₂₅N₃O₂S
Molecular Weight	335.47 g/mol
Synonyms	Almotriptan Related Compound B; Almotriptan Impurity B; 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine; Almotriptan Sulfoxide; Almotriptan EP Impurity B; Almotriptan USP Impurity 2
EINECS	Contact for details

Quality Control

Our Almotriptan Impurity 2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

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

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