Description

Eliglustat Hemitartrate CAS NO 928659-70-5 is a high-purity, small-molecule pharmaceutical active ingredient used as a substrate reduction therapy. It is a critical component in the treatment of Gaucher disease type 1, functioning as a potent and selective glucosylceramide synthase inhibitor to reduce the accumulation of glucocerebroside. This compound is essential for pharmaceutical manufacturers and research institutions developing targeted therapies for lysosomal storage disorders, requiring material of the highest quality and consistency for formulation and clinical studies.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of oral capsules and tablets in the treatment of Gaucher disease.
• Pharmaceutical Research & Development for investigating new therapeutic applications and combination therapies.
• Reference Standard in analytical laboratories for quality control, method development, and validation.
• Process Development for scale-up and optimization of synthesis routes in chemical development.
• Biochemical Research as a tool compound for studying glycosphingolipid metabolism and related pathways.

Basic Information

Product Name	Eliglustat Hemitartrate
CAS No.	928659-70-5
Molecular Formula	C23H36N2O4 • 0.5C4H6O6
Molecular Weight	447.55 g/mol (free base: 392.55)
Synonyms	Eliglustat Tartrate; GZ/SD-674; GZSD674; N-[(1R,2R)-1-(2,3-Dihydro-1,4-benzodioxin-6-yl)-1-hydroxy-3-(1-pyrrolidinyl)-2-propanyl]octanamide hemicitrate; Cerdelga (Brand Name); Genz-112638; (1R,2R)-Octanoyl-1-(2,3-dihydro-1,4-benzodioxin-6-yl)-1,2-dihydroxy-3-pyrrolidin-1-ylpropane Hemitartrate
EINECS	Contact for details

Quality Control

Our Eliglustat Hemitartrate is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical development. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and mass spectrometry. Our quality commitment aligns with cGMP principles to support our clients' regulatory submissions.

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 inert conditions or in a desiccator to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Optical Rotation	Specific range provided on COA

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