Description

Almotriptan Dimer Impurity is a high-purity reference standard specifically designed for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the purity and safety profile of the active pharmaceutical ingredient (API) Almotriptan, a medication used to treat migraines. It serves as an essential tool for researchers and quality assurance professionals in pharmaceutical R&D and manufacturing, enabling accurate identification, quantification, and control of this specific process-related impurity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Quality Control & Assurance (QC/QA): Used in HPLC, LC-MS, and other chromatographic systems to quantify and monitor the Almotriptan dimer impurity levels during API synthesis and final drug product testing.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed to track the formation and levels of this impurity in Almotriptan drug substances and products under various storage conditions over time.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this dimer impurity.
• Contract Research & Testing Laboratories (CROs/CTLs): A vital reagent for laboratories offering analytical testing services to the pharmaceutical industry.

Basic Information

Product Name	Almotriptan Dimer Impurity
CAS No.	1330166-13-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Almotriptan Dimer; Almotriptan Related Compound Dimer; Almotriptan Impurity Dimer; Almotriptan Process Impurity; 5-[[(3S)-1-Methyl-3-pyrrolidinyl]methyl]-1H-indole-3-ethanesulfonamide Dimer Impurity; AXERT Impurity Dimer; LAS 31416 Dimer Impurity
EINECS	Contact for details

Quality Control

Every batch of Almotriptan Dimer Impurity CAS NO 1330166-13-6 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity confirmation, and impurity profiles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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