Description

Eliglustat Impurity 2 (Eliglustat Sr-Isomer) is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Eliglustat. This compound serves as a key stereoisomeric impurity, essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of therapies for Gaucher disease.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the Sr-isomer impurity in Eliglustat API and finished dosage forms.
• Method Development & Validation: Essential for developing, optimizing, and validating robust analytical methods, particularly chiral separation techniques like HPLC and UPLC.
• Quality Control & Batch Release: Critical for routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Eliglustat, meeting ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific isomer under various stress conditions.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and qualification data.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the behavior of isomeric impurities.

Basic Information

Product Name	Eliglustat Impurity 2 (Eliglustat Sr-Isomer)
CAS No.	1092472-66-6
Molecular Formula	C23H39N3O4
Molecular Weight	421.58 g/mol
Synonyms	Eliglustat Related Compound B; (1S,2R)-Eliglustat; Eliglustat Stereoisomer; (1S,2R)-1-(2,3-Dihydro-1,4-benzodioxin-6-yl)-2-[[(2R,3R,4S)-3,4-dihydroxy-1-(octylamino)-4-pentyl-2-pyrrolidinyl]methyl]amino]-1-propanol; Eliglustat EP Impurity B; Eliglustat Diastereomer; GZ/SD674 Impurity
EINECS	Contact for details

Quality Control

Every batch of Eliglustat Impurity 2 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including chiral purity assay, identification by spectroscopic methods, and control of related substances and residual solvents to meet stringent pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specifications. Our quality systems support development and commercial needs under cGMP and ISO 9001 frameworks.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccant use.

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%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual 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.