Description

Doxapram Ep Impurity A is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of a specified impurity in Doxapram active pharmaceutical ingredient (API) and finished drug products. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory compliance teams to ensure product safety, efficacy, and adherence to stringent pharmacopeial standards like the European Pharmacopoeia (EP).

Application

• Pharmaceutical Impurity Profiling and Method Development: Serves as a certified reference material for developing and validating analytical methods (e.g., HPLC, GC) to detect and quantify Doxapram Ep Impurity A.
• Quality Control (QC) and Release Testing: Used as a primary standard in QC laboratories to confirm the impurity levels in Doxapram API batches comply with EP and ICH Q3A/B guidelines.
• Stability Studies and Degradation Pathway Analysis: Employed to study the formation of this impurity under various stress conditions, aiding in understanding drug degradation pathways.
• Regulatory Submissions and Compliance: Critical for preparing documentation for regulatory agencies (EMA, FDA) to demonstrate thorough impurity control strategies.
• Research and Development (R&D): Used in synthetic chemistry and process development to optimize manufacturing routes and minimize impurity formation.
• Calibration of Analytical Instruments: Acts a precise calibrant to ensure the accuracy and reliability of spectroscopic and chromatographic systems.

Basic Information

Product Name	Doxapram Ep Impurity A
CAS No.	3192-64-1
Molecular Formula	C24H30N2O2
Molecular Weight	378.51 g/mol
Synonyms	1-Ethyl-4-(2-morpholinoethyl)-3,3-diphenyl-2-pyrrolidinone; Doxapram Related Compound A; Doxapram Impurity A; Doxapram EP Impurity A; 2-Pyrrolidinone, 1-ethyl-4-[2-(4-morpholinyl)ethyl]-3,3-diphenyl-; AHR-619; CCG-40258
EINECS	Contact for details

Quality Control

Our Doxapram Ep Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, IR and NMR for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 maximum stability.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.