Description

Gadoxetate Disodium Impurity 2 Trihydrochloride is a high-purity chemical reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity in the synthesis and purification of Gadoxetate Disodium, a key contrast agent used in magnetic resonance imaging (MRI). It is essential for analytical chemists, quality assurance professionals, and research scientists working in pharmaceutical development, regulatory compliance, and advanced diagnostic imaging. Ensuring the accurate identification and quantification of this impurity is fundamental to maintaining the safety, efficacy, and regulatory approval of final pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Gadoxetate Disodium active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling in contrast agent manufacturing.
• Quality Control & Assurance (QC/QA): Used in-house by pharmaceutical manufacturers to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Submission & Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Research & Development (R&D): Employed in stability studies and degradation pathway analysis to understand the behavior of Gadoxetate Disodium under various conditions.
• Contract Research Organization (CRO) Services: Supplied to third-party testing laboratories offering specialized analytical services to the pharmaceutical industry.

Basic Information

Product Name	Gadoxetate Disodium Impurity 2 Trihydrochloride
CAS No.	2183894-92-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gadoxetate Disodium Related Compound 2; Gadoxetate Impurity 2 HCl; Gd-EOB-DTPA Impurity 2 trihydrochloride; Primovist Impurity 2 trihydrochloride; Eovist Impurity 2 trihydrochloride; (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxymethyl)-11-oxo-3,6,9,12-tetraazatetradecanedioic acid Impurity 2 trihydrochloride; Gadolinium 1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetraacetate Impurity 2 HCl
EINECS	Contact for details

Quality Control

Every batch of Gadoxetate Disodium Impurity 2 Trihydrochloride is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopeial requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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