Description

Tetraxetan Related Compound A (25 Mg) (2,2',2"-[10-(2-Ethoxy-2-Oxoethyl)-1,4,7,10-Tetraazacyclododecane-1,4,7-Triyl]Triacetic Acid) is a high-purity chemical reference standard, a key structural analog of the chelating agent DOTA (tetraxetan). This compound is essential for analytical method development and validation, ensuring the accuracy and reliability of quality control processes in pharmaceutical manufacturing. It is primarily used by researchers and quality assurance professionals in the radiopharmaceutical, diagnostic imaging, and advanced pharmaceutical sectors for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of DOTA (tetraxetan) and its derivatives in active pharmaceutical ingredients (APIs).
• Radiopharmaceutical R&D: Serves as a critical non-radioactive analog in the development and quality control of metal-chelating agents for diagnostic and therapeutic radiopharmaceuticals.
• HPLC/LC-MS Method Development: Employed to develop, validate, and calibrate chromatographic methods for the precise quantification of related substances.
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Chemical Synthesis Research: Acts as a building block or intermediate in the synthesis of novel macrocyclic chelators and contrast agents.
• Quality Control Laboratories: Used for routine batch testing to ensure the purity and consistency of DOTA-conjugated drugs and imaging agents.

Basic Information

Product Name	Tetraxetan Related Compound A (25 Mg) (2,2',2"-[10-(2-Ethoxy-2-Oxoethyl)-1,4,7,10-Tetraazacyclododecane-1,4,7-Triyl]Triacetic Acid)
CAS No.	2101625-18-5
Molecular Formula	C20H34N4O9
Molecular Weight	474.51 g/mol
Synonyms	2,2',2"-[10-(2-Ethoxy-2-Oxoethyl)-1,4,7,10-Tetraazacyclododecane-1,4,7-Triyl]triacetic Acid; DOTA Monoamide Derivative; 1,4,7,10-Tetraazacyclododecane-1,4,7-triacetic Acid, 10-(2-Ethoxy-2-Oxoethyl)-; DOTA Related Compound A; Tetraxetan Impurity A; Cyclen-based Chelator Derivative; DO3A Monoethyl Ester
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and mass spectrometry to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, impurities, and chromatographic profiles. Our quality protocols are designed to meet the stringent requirements of pharmaceutical R&D and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH 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.