Description

Ambazone Impurity CAS NO 67381-67-3 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Ambazone or related pharmaceutical compounds.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of specific degradation products.
• Quality Control & Batch Release: Acts as a system suitability standard and for routine quality control testing of API batches to ensure they meet pharmacopeial specifications.
• Research & Development: Used in synthetic chemistry R&D to study reaction pathways and optimize processes to minimize impurity formation.

Basic Information

Product Name	Ambazone Impurity
CAS No.	67381-67-3
Molecular Formula	C8H11N7S
Molecular Weight	237.28 g/mol
Synonyms	1,4-Benzoquinone, 2-(aminocarbonothioyl)hydrazone; Ambazone Related Compound; 2-Carbamothioylhydrazinylidenecyclohexa-2,5-diene-1,4-dione; Thiocarbamoylhydrazone of p-Benzoquinone; p-Benzoquinone thiosemicarbazone; Ambazone Impurity A; Ambazone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ambazone Impurity CAS NO 67381-67-3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting cGMP and ISO 9001 requirements for traceability and quality assurance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which may affect stability and purity. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.