Description

Gadoteridol Related Compound C (50 Mg) (1,4,7,10-Tetraaza-11-Oxo-Bicyclo[8.2.2]Tetrade-Cane-4,7-Diacetic Acid) is a high-purity chemical reference standard, specifically a related substance of the magnetic resonance imaging (MRI) contrast agent Gadoteridol. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and regulatory testing facilities to ensure the purity, safety, and efficacy of contrast media products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Gadoteridol-related impurities in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) for the analysis of Gadoteridol and its degradation products.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine testing in QC laboratories to monitor process consistency and product purity against pharmacopeial specifications.
• Regulatory Compliance & Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization of the drug substance.
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track potential degradation pathways of Gadoteridol.
• Research on Contrast Agent Chemistry: Used in academic and industrial research to study the structure, properties, and behavior of macrocyclic gadolinium-based contrast agents.

Basic Information

Product Name	Gadoteridol Related Compound C (50 Mg) (1,4,7,10-Tetraaza-11-Oxo-Bicyclo[8.2.2]Tetrade-Cane-4,7-Diacetic Acid)
CAS No.	220182-19-4
Molecular Formula	C14H22N4O7
Molecular Weight	358.35 g/mol
Synonyms	1,4,7,10-Tetraaza-11-oxobicyclo[8.2.2]tetradecane-4,7-diacetic Acid; Gadoteridol Impurity C; ProHance Related Compound C; Bicyclo[8.2.2]tetradecane-4,7-diacetic Acid, 1,4,7,10-tetraaza-11-oxo-; (4,7-Bis(carboxymethyl)-1,4,7,10-tetraaza-11-oxobicyclo[8.2.2]tetradecan-4-ium-7-ide); Gadoteridol Intermediate; Macrocyclic DOTA-like Ligand Derivative
EINECS	Contact for details

Quality Control

This analytical standard is manufactured under strict quality control conditions to ensure identity, purity, and consistency. Each batch is characterized using advanced analytical techniques including HPLC, NMR, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is supplied with each unit, providing batch-specific data on assay, related substances, and residual solvents. Our quality system is designed to support pharmaceutical development and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.