Description

Eliglustat (1S,2S)-Isomer (Hemitartrate) is a high-purity, stereochemically defined active pharmaceutical ingredient (API) and key intermediate. This compound is the specific (1S,2S)-isomer of eliglustat, a glucosylceramide synthase inhibitor, which is critical for ensuring the desired pharmacological activity and minimizing off-target effects. It is essential for pharmaceutical R&D, process development, and the manufacture of reference standards for the treatment of Gaucher disease type 1. The product is supplied with full traceability and comprehensive analytical documentation.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary use in the commercial manufacturing of eliglustat drug products.
• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for quality control and analytical method development.
• Process Chemistry & Route Scouting: Used in the development and optimization of synthetic pathways for eliglustat production.
• Formulation Development: Employed in pre-formulation studies and the development of final dosage forms (e.g., capsules).
• Regulatory Submissions: Provides the necessary high-purity material for generating data for IND, NDA, and other global regulatory filings.
• Metabolite & Impurity Studies: Acts as a precursor or standard for synthesizing and identifying related substances and metabolites.

Basic Information

Product Name	Eliglustat (1S,2S)-Isomer (Hemitartrate)
CAS No.	1092472-70-2
Molecular Formula	C23H45N3O4 • C4H6O6
Molecular Weight	659.84 g/mol (hemitartrate salt)
Synonyms	(1S,2S)-Eliglustat Hemitartrate; (1S,2S)-N-((1-Propylpiperidin-3-yl)methyl)-2-(2-(tetradecyloxy)phenyl)acetamide Hemitartrate; GZ/SAR402671 Hemitartrate; Cerdelga (1S,2S)-Isomer Salt; (1S,2S)-Genz-112638 Hemitartrate; (1S,2S)-Eliglustat Tartrate (1:0.5); (1S,2S)-2-(2-(Tetradecyloxy)benzamido)-1-(3-(propylamino)propyl)propyl Carbamate Hemitartrate
EINECS	Contact for details

Quality Control

Our Eliglustat (1S,2S)-Isomer (Hemitartrate) is manufactured under strict quality systems. Each batch is released only after passing a comprehensive battery of analytical tests to ensure identity, purity, and strength. We provide full ICH-compliant impurity profiling and can support specifications aligned with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines. A detailed Certificate of Analysis (COA) with batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The container should be kept securely sealed to protect against moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Enantiomeric Purity (Chiral HPLC)	≥ 99.0% (1S,2S)-Isomer
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C Class 2 & 3 limits

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