Description

Ambazone Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the active pharmaceutical ingredient Ambazone. It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in impurity profiling, method development, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Ambazone drug substances and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical standard to develop, optimize, and validate chromatographic methods for purity analysis.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Ambazone formulations to monitor impurity formation.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Used in routine QC laboratories as a system suitability standard and for calibrating analytical instruments to ensure accurate impurity detection.
• Chemical Research & Synthesis: Acts as a building block or intermediate for researchers studying the chemistry, metabolism, or derivative synthesis of Ambazone-related compounds.

Basic Information

Product Name	Ambazone Impurity 2
CAS No.	1945-63-7
Molecular Formula	C8H11N7S
Molecular Weight	237.29 g/mol
Synonyms	1,4-Benzoquinone, 2,5-bis[(aminoiminomethyl)hydrazone]; 2,5-Bis(amidinohydrazono)-2,5-cyclohexadiene-1,4-dione; Ambazon impurity B; Ambazone Related Compound B; 1,4-Benzoquinone bis(amidinohydrazone); 1945-63-7; Ambazone EP Impurity B
EINECS	Contact for details

Quality Control

Our Ambazone Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, 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). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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