Description

Demiditraz Impurity CAS NO 944267-48-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It is primarily required by analytical chemists, quality control laboratories, and R&D departments within the pharmaceutical and agrochemical industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of process-related impurities in active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods like HPLC and UPLC.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in QC laboratories to monitor and control impurity levels, ensuring product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to track impurity formation over time.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer forms of the target molecule.

Basic Information

Product Name	Demiditraz Impurity
CAS No.	944267-48-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Demiditraz Related Compound; Demiditraz Impurity Standard; Demiditraz EP Impurity; Demiditraz USP Impurity; Demiditraz Process Impurity; Demiditraz Degradant; (Specific IUPAC name to be confirmed)
EINECS	Contact for details

Quality Control

Every batch of Demiditraz Impurity (CAS 944267-48-5) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 ensure 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

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