Description

Carboxyamidotriazole Impurity 2 is a defined chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the purity, safety, and regulatory compliance of active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by researchers and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors for method validation and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Carboxyamidotriazole and related drug substances.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and mass spectrometry (MS) methods.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in quality control laboratories to monitor batch-to-batch consistency and ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive characterization data for impurity profiles in drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of specific impurities under various environmental conditions.
• Research & Development (R&D): Utilized in synthetic chemistry R&D to understand degradation pathways and optimize purification processes for the parent drug compound.

Basic Information

Product Name	Carboxyamidotriazole Impurity 2
CAS No.	203202-66-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	CAI Impurity 2; Carboxyamidotriazole Related Compound 2; L-651582 Impurity; 1H-Benzimidazole-4-carboxamide, 2-[(4-aminophenyl)methyl]-5-chloro-α,α-difluoro-N-methyl-; 2-[(4-Aminobenzyl)]-5-chloro-α,α-difluoro-N-methyl-1H-benzimidazole-4-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Carboxyamidotriazole Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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