Description

Demiditraz Impurity CAS NO 944268-66-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for pharmaceutical quality control, specifically in the development and validation of analytical methods for the active pharmaceutical ingredient Demiditraz. It is essential for laboratories in the pharmaceutical and agrochemical industries requiring precise impurity profiling to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Demiditraz drug substances and products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods such as HPLC and LC-MS.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor batch-to-batch consistency and ensure adherence to strict pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Demiditraz.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in synthetic chemistry R&D for route scouting and process optimization to minimize the formation of this specific impurity.

Basic Information

Item	Details
Product Name	Demiditraz Impurity
CAS No.	944268-66-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Demiditraz Related Compound; Demiditraz Process Impurity; Demiditraz Specified Impurity; 1,3-Dimethyl-1H-pyrazole-4-carboxylic acid (2,6-dichloro-4-(trifluoromethyl)phenyl)amide; (2,6-Dichloro-α,α,α-trifluoro-p-tolyl)-1,3-dimethylpyrazole-4-carboxamide; Potential intermediate or by-product in Demiditraz synthesis.
EINECS	Contact for details

Quality Control

Our Demiditraz Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity levels is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions 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 unspecified 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.