Description

Duvoglustat Hydrochloride is a high-purity, small molecule pharmaceutical active ingredient. This compound is a potent and selective inhibitor of acid α-glucosidase (GAA), making it a critical intermediate and reference standard in the research and development of treatments for Pompe disease and related lysosomal storage disorders. It is essential for pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in metabolic disease research, process development, and quality control of therapeutic agents.

Application

• Pharmaceutical Active Pharmaceutical Ingredient (API): Serves as the key therapeutic agent in the formulation of investigational drugs for enzyme replacement therapy.
• Biochemical Research: Used as a potent and specific inhibitor in enzymatic studies to understand GAA function and glycogen metabolism pathways.
• Reference Standard: Employed in analytical laboratories for method development, validation, and quality control (HPLC, LC-MS) of drug substances and products.
• Process Development & Scale-up: A crucial intermediate for chemical process R&D teams optimizing synthesis routes for GAA inhibitors.
• Pre-clinical & Clinical Studies: Utilized in the production of batches for toxicology, pharmacokinetics, and early-phase clinical trials.

Basic Information

Product Name	Duvoglustat Hydrochloride
CAS No.	308362-25-6
Molecular Formula	C23H26N2O5 • HCl
Molecular Weight	462.92 g/mol (Hydrochloride salt)
Synonyms	AT2220 Hydrochloride; 1-Deoxynojirimycin Derivative AT2220 HCl; (2R,3R,4R,5S)-2-(Hydroxymethyl)-1-[(1S,2S)-2-hydroxy-2,3-dihydro-1H-inden-1-yl]piperidine-3,4,5-triol hydrochloride; Isofagomine tartrate derivative; GAA Inhibitor AT2220; Acid α-Glucosidase Inhibitor
EINECS	Contact for details

Quality Control

Our Duvoglustat Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical intermediates and reference standards. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Related Substances (HPLC)	Total impurities ≤2.0%; Any single unknown impurity ≤0.5%
Heavy Metals	≤20 ppm

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