Description

Almotriptan Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Almotriptan. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and method validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of this specific impurity in Almotriptan API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods.
• Quality Control (QC) and Quality Assurance (QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Regulatory Compliance and Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to track the formation of degradation products in Almotriptan formulations under various storage conditions.
• Research and Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the behavior of Almotriptan-related substances.

Basic Information

Item	Detail
Product Name	Almotriptan Impurity 1
CAS No.	334981-31-6
Molecular Formula	C₁₇H₂₅N₃O₂S
Molecular Weight	335.47 g/mol
Synonyms	1-[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine; Almotriptan Related Compound A; Almotriptan Sulfone; Almotriptan Impurity A; Almotriptan EP Impurity A; N-[(3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl)methyl]methanesulfonamide N-oxide (incorrect but sometimes listed); Almotriptan Metabolite (potential)
EINECS	Contact for details

Quality Control

Every batch of Almotriptan Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substances, and identification tests performed in compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. This product is light-sensitive and should be handled accordingly 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.