Description

Gadoteridol Related Compound B (50 Mg) (1,4,7,10-Tetraazacyclododecane-1,4,7-Triacetic Acid, Monogadolinium Salt) is a high-purity chemical reference standard essential for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a critical impurity marker for the magnetic resonance imaging (MRI) contrast agent Gadoteridol, ensuring product safety and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the synthesis and purification of gadolinium-based contrast agents.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Gadoteridol active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch release testing to ensure Gadoteridol meets stringent pharmacopeial specifications (e.g., USP, EP) for impurity limits.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Acts as a benchmark to track the formation of degradation products in Gadoteridol formulations under various storage conditions.
• Research on Contrast Agent Chemistry: Utilized in academic and industrial research to study the complexation chemistry, stability, and metabolism of macrocyclic gadolinium chelates.

Basic Information

Product Name	Gadoteridol Related Compound B (50 Mg) (1,4,7,10-Tetraazacyclododecane-1,4,7-Triacetic Acid, Monogadolinium Salt)
CAS No.	112188-16-6
Molecular Formula	C16H25GdN4O7
Molecular Weight	558.66 g/mol
Synonyms	Gadoteridol Impurity B; ProHance Related Compound B; Gadoteridol EP Impurity B; Gadoteridol USP Related Compound B; Monogadolinium 1,4,7,10-Tetraazacyclododecane-1,4,7-triacetate; Gd-DO3A; Gadolinium(III) 1,4,7,10-tetraazacyclododecane-1,4,7-triacetate
EINECS	Contact for details

Quality Control

Our Gadoteridol Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS), 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 every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed immediately after use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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