Description

Gadobutrol Impurity 1 is a specified impurity of the magnetic resonance imaging (MRI) contrast agent Gadobutrol. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient. It is primarily required by manufacturers of contrast media, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Gadobutrol Impurity 1 in Gadobutrol bulk drug substance and finished injectable formulations.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS) techniques.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity profiles and ensure compliance with International Council for Harmonisation (ICH) Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate control strategies for known and potential impurities.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Gadobutrol.

Basic Information

Product Name	Gadobutrol Impurity 1
CAS No.	216670-14-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gadobutrol Related Compound A; Gadobutrol EP Impurity A; Gadobutrol USP Impurity; Gadobutrol Degradation Product; (10S)-10-[(2S)-1-Hydroxybutan-2-yl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid gadolinium complex impurity; Gadobutrol Specified Impurity; MRI Contrast Agent Impurity; Gadolinium-based Contrast Agent Impurity
EINECS	Contact for details

Quality Control

Every batch of Gadobutrol Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing results for appearance, identification (HPLC, MS), assay (HPLC), and related substances, is provided with each shipment to support your regulatory and quality needs.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to prevent oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0%; Total impurities ≤ 5.0%
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.