Description

Eldecalcitol Impurity 3 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Eldecalcitol. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development and production of vitamin D analogs and related therapeutic agents.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Eldecalcitol API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways in stability testing of Eldecalcitol under various storage conditions.
• Process Chemistry & Optimization: Used by R&D and process chemists to identify, track, and minimize the formation of this specific impurity during API synthesis and purification steps.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability test component and for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Eldecalcitol Impurity 3
CAS No.	201854-22-0
Molecular Formula	C27H44O3
Molecular Weight	416.64 g/mol
Synonyms	(5Z,7E)-(1S,3R)-9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol; 1α,25-Dihydroxy-2β-(3-hydroxypropoxy)vitamin D3; ED-71 Impurity 3; Eldecalcitol Related Compound C; 2β-(3-Hydroxypropoxy)-1α,25-dihydroxyvitamin D3
EINECS	Contact for details

Quality Control

Every batch of Eldecalcitol Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including HPLC purity analysis, spectroscopic identification (NMR, IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This material is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed under an inert atmosphere after each use to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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