Description

Dropropizine Impurity 1 CAS NO 152323-00-7 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 the antitussive pharmaceutical ingredient, Dropropizine. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for accurate quantification and control of related substances in active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specific impurity in Dropropizine API and its formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor and control the levels of this specific impurity, ensuring drug product specifications are met.
• Stability Studies: Utilized as a reference marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions and Compliance: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports chemical research into the synthesis, degradation pathways, and metabolism of Dropropizine and related compounds.

Basic Information

Product Name	Dropropizine Impurity 1
CAS No.	152323-00-7
Molecular Formula	C13H20N2O2
Molecular Weight	236.31 g/mol
Synonyms	1-(2-Phenoxyethyl)-4-(2-methoxyethyl)piperazine; 4-(2-Methoxyethyl)-1-(2-phenoxyethyl)piperazine; Dropropizine Related Compound A; Dropropizine EP Impurity A; Dropropizine Process Impurity; L-Carbetapentane Impurity (related); Oxeladin Impurity (related); Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Our Dropropizine Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity and purity. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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