Description

Eliglustat Impurity 1 (Eliglustat Rs-Isomer) is a designated stereoisomeric impurity of the active pharmaceutical ingredient Eliglustat, a medication used for the treatment of Gaucher disease type 1. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Eliglustat drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of the Rs-isomer in Eliglustat API and drug products.
• Analytical Method Development: Crucial for developing and validating chromatographic methods (HPLC, UPLC) to separate and analyze stereoisomeric impurities.
• Quality Control & Assurance: Used in routine batch testing to monitor and control impurity profiles, ensuring compliance with ICH Q3A and Q3B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product or isomer over time under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in optimizing synthesis pathways to minimize the formation of this isomer during API manufacturing.

Basic Information

Product Name	Eliglustat Impurity 1 (Eliglustat Rs-Isomer)
CAS No.	1092472-65-5
Molecular Formula	C23H36N2O4
Molecular Weight	404.55 g/mol
Synonyms	Eliglustat Related Compound Rs-Isomer; (1R,2R)-1-(2,3-Dihydro-1,4-benzodioxin-6-yl)-2-(octahydro-2H-isoindol-2-yl)pentyl (2S)-2-Aminobutanedioate; Eliglustat Stereoisomer Impurity; GZ/SD-674 Rs-Isomer; Cerdelga Impurity Rs-Isomer; (R,R)-Eliglustat (S)-Hydrogen Succinate; Eliglustat Diastereomer
EINECS	Contact for details

Quality Control

Every batch of Eliglustat Impurity 1 is manufactured and analyzed under strict quality systems. It undergoes comprehensive testing using advanced techniques like HPLC, GC, and NMR to confirm identity, purity, and strength. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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