Description

Almotriptan 2-Hydroxy Impurity is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Almotriptan. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker for related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of migraine medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the 2-hydroxy impurity in Almotriptan API and finished dosage forms.
• Method Development & Validation: Essential for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Almotriptan batches comply with stringent pharmacopeial limits (e.g., USP, EP, ICH Q3A/B) for related substances.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Almotriptan 2-Hydroxy Impurity
CAS No.	1309457-19-9
Molecular Formula	C17H25N3O2S
Molecular Weight	335.47 g/mol
Synonyms	2-Hydroxy Almotriptan; Almotriptan Related Compound; Almotriptan Impurity; Almotriptan 2-Hydroxy Derivative; 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine-2-methanol; Almotriptan Hydroxy Impurity; Almotriptan EP Impurity; Almotriptan USP Impurity
EINECS	Contact for details

Quality Control

Our Almotriptan 2-Hydroxy Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.5%
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.