Description

Eliglustat D4 is a deuterated isotopologue of eliglustat, a potent and selective inhibitor of glucosylceramide synthase. This stable-labeled compound is an essential reference standard and internal standard for the precise quantification and pharmacokinetic studies of eliglustat in biological matrices using mass spectrometry. It is primarily utilized by pharmaceutical research and development laboratories, contract research organizations (CROs), and analytical testing facilities involved in drug metabolism and bioanalytical method development.

Application

• Primary use as an internal standard for the accurate LC-MS/MS bioanalysis of eliglustat in plasma, serum, and other biological samples.
• Critical reference material for method development, validation, and quality control in pharmacokinetic (PK) and toxicokinetic (TK) studies.
• Used in drug metabolism and disposition (DMPK) research to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of eliglustat.
• Essential for ensuring regulatory compliance and data integrity in bioanalytical assays supporting clinical trials for Gaucher disease treatment.
• Supports pharmaceutical impurity profiling and stability studies where deuterated analogs are used as markers.

Basic Information

Product Name	Eliglustat D4
CAS No.	1628700-81-1
Molecular Formula	C23H42D4N2O4
Molecular Weight	406.64 g/mol (approximate)
Synonyms	Eliglustat-d4; (1R,2R)-Octanoic acid, 2-(2,3-dihydro-1H-indol-1-yl)-1-[(1-pyrrolidinyl)methyl]propyl ester-d4; N-[(1R,2R)-1-(2,3-Dihydro-1H-indol-1-yl)-1-benzyl-3-(pyrrolidin-1-yl)-2-hydroxypropyl]octanamide-d4; Cerdelga-d4; Genz-112638-d4; GZ-112638-d4; Stable Isotope Labeled Eliglustat
EINECS	Contact for details

Quality Control

Our Eliglustat D4 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (D-atom %), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We adhere to relevant ICH guidelines for analytical validation, ensuring reliability for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-atom %)	≥98.0%
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Meets ICH limits

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