Migalastat HCl

Migalastat HCl is a pivotal pharmaceutical intermediate and certified reference standard in the industrial synthesis and quality control of this first-in-class pharmacological chaperone for Fabry disease. The piperidine ring of Migalastat HCl is synthesized through a multi-step process starting from D-(+)-galactose, involving the formation of 1,2,3,6-tetrapivaloyl-D-galactofuranoside followed by selective transformations to install the correct stereochemistry. In quality control contexts, Migalastat HCl and its related impurities—including Migalastat Impurity 1 (Lucerastat) and various process-related byproducts—are essential analytical reference standards for impurity profiling, analytical method development, and quality control testing. As the hydrochloride salt, Migalastat HCl offers excellent aqueous solubility and improved crystallinity compared to the free base. The iminosugar scaffold of Migalastat HCl serves as a versatile platform for pharmacological chaperone development, making Migalastat HCl indispensable for pharmaceutical manufacturers developing generic versions and for analytical laboratories performing quality control testing.

 

Product Parameters

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Parameter	Specification
Product Name	Migalastat HCl
CAS Number	75172-81-5
Molecular Formula	C₆H₁₃NO₄ · HCl
Molecular Weight	199.63 g/mol
Appearance	White to pale brown solid
Melting Point	260℃
Storage Condition	4°C, dry, sealed; or –20°C

 

Application

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Deoxygalactose emamectin hydrochloride is an effective and competitive inhibitor of α-galactosidase A, with an IC50 value of 0.04 μM for human α-Gal A.

 

Target

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IC50: 0.04 μM (human α-Gal A);Ki: 0.04 μM (human α-Gal A)

 

Product Advantages

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First-in-Class Pharmacological Chaperone for Fabry Disease

Migalastat HCl is a first-in-class pharmacological chaperone that selectively binds, stabilizes, and increases cellular levels of mutant α-galactosidase A. This unique mechanism enables oral treatment for Fabry disease patients with amenable mutations.

 

 Rigid Iminosugar Scaffold with Defined Stereochemistry

The piperidine ring of Migalastat HCl contains four asymmetric carbon atoms with the same stereochemistry as D-galactose. This rigid, conformationally locked architecture pre-organizes the hydroxyl groups for optimal interaction with the α-Gal A active site.

 

 Excellent Aqueous Solubility

Migalastat HCl is freely soluble in water (≥200 mg/mL) across a broad pH range (1.2–7.5). The hydrochloride salt form offers three critical advantages: exceptional aqueous solubility for biological assays, a non-hygroscopic crystalline solid for convenient handling, and enhanced long-term storage stability.

 

 Comprehensive Impurity Reference Standards

Cosperpharm supplies Migalastat HCl and its related impurities—including Migalastat Impurity 1 (Lucerastat) and N-Nitroso Migalastat—as certified reference standards. These are essential for ANDA filings, method validation, and quality control.

 

 Broad Research Applications

Migalastat HCl serves as an α-galactosidase A inhibitor for enzymatic activity assessment and as a pharmacological chaperone for Fabry disease research. The iminosugar scaffold also has applications in glycobiology and lysosomal storage disorder research.

 

Contact Us

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Looking for Migalastat HCl for your Fabry disease therapeutic development, impurity profiling program, or pharmacological chaperone research? Cosperpharm delivers with reliability, transparency, and technical expertise—contact us today.