Description

Demiditraz Impurity 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 by serving as a benchmark in impurity profiling and method validation. It is primarily required by analytical laboratories, quality control units, and research scientists within the pharmaceutical and agrochemical development sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of process-related impurities in active pharmaceutical ingredients (APIs).
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating chromatographic methods like HPLC and LC-MS.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels against established specifications.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of degradation impurities in drug substances and products over time under various storage conditions.
• Research and Development (R&D): Used in synthetic chemistry research to study degradation pathways and to synthesize and characterize related substances.

Basic Information

Product Name	Demiditraz Impurity
CAS No.	944268-65-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Demiditraz Related Compound; Demiditraz Impurity Standard; Demiditraz EP Impurity; Demiditraz USP Impurity; Demiditraz Analytical Standard; Specific impurity of Demiditraz; (Chemical name based on structure to be confirmed)
EINECS	Contact for details

Quality Control

Every batch of Demiditraz Impurity is manufactured and handled under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial and industry standards. 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 in a cool, dry, and well-ventilated area at controlled room temperature (typically 15-25°C). For long-term stability, consider storage under inert atmosphere if the compound is easily oxidized.

Specification

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

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