Description

Gadoteridol Related Compound A (50 Mg) (10-(2-Hydroxypropyl)-1,4,7,10-Tetraazacyclodode-Cane-1,4,7-Triacetic Acid) is a high-purity chemical reference standard, critical for ensuring the quality and safety of pharmaceutical products. This compound is essential for the analytical profiling and impurity control of the magnetic resonance imaging (MRI) contrast agent, Gadoteridol. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in the development, validation, and regulatory compliance of contrast media.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material for the identification and quantification of specific impurities in Gadoteridol active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for Gadoteridol analysis.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels, ensuring batches of Gadoteridol comply with strict pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Gadoteridol.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on MRI Contrast Agents: Used in academic and industrial research to study the chemistry, metabolism, and safety profile of macrocyclic gadolinium-based contrast agents.

Basic Information

Product Name	Gadoteridol Related Compound A (50 Mg) (10-(2-Hydroxypropyl)-1,4,7,10-Tetraazacyclodode-Cane-1,4,7-Triacetic Acid)
CAS No.	120041-08-9
Molecular Formula	C17H30N4O7
Molecular Weight	402.44 g/mol
Synonyms	10-(2-Hydroxypropyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid; HPDO3A; ProHance Ligand; Gadoteridol Impurity A; Gadoteridol Intermediate; 1,4,7-Tris(carboxymethyl)-10-(2-hydroxypropyl)-1,4,7,10-tetraazacyclododecane; DO3A-HP
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality control conditions. Each batch is characterized and tested using advanced analytical techniques including NMR, HPLC, and mass spectrometry to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results. Our quality system is designed to support GMP and ISO 9001 compliance for our pharmaceutical and research partners.

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 product 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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