Description

Doxapram Related Compound B (25 Mg) (1-Ethyl-4-{2-[(2-Hydroxyethyl)Amino]Ethyl}-3,3-Diphenylpyrrolidin-2-One, Hydrochloride) is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound, with CAS number 100106-91-0, serves as a specified impurity or degradation product of the respiratory stimulant Doxapram Hydrochloride, making it essential for ensuring drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for precise identification, quantification, and monitoring of impurities in active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of related substances in Doxapram Hydrochloride API and its formulations according to ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods to separate and analyze Doxapram and its impurities.
• Stability Studies & Forced Degradation: Employed as a marker to understand degradation pathways and establish shelf-life specifications for Doxapram-based drug products.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure compliance with pharmacopeial monographs (USP, EP, BP).
• Regulatory Submissions: Provides critical data on impurity levels for inclusion in regulatory filings (e.g., FDA, EMA) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Research & Development: Used in metabolic and pharmacokinetic studies to investigate the fate of related compounds in biological systems.

Basic Information

Product Name	Doxapram Related Compound B (25 Mg) (1-Ethyl-4-{2-[(2-Hydroxyethyl)Amino]Ethyl}-3,3-Diphenylpyrrolidin-2-One, Hydrochloride)
CAS No.	100106-91-0
Molecular Formula	C22H29N2O2 • HCl
Molecular Weight	396.94 g/mol (Free base: 360.48 g/mol)
Synonyms	1-Ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-3,3-diphenyl-2-pyrrolidinone hydrochloride; Doxapram Impurity B; Doxapram Related Substance B; Doxapram EP Impurity B; Doxapram Hydrochloride Related Compound B; 3,3-Diphenyl-1-ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-2-pyrrolidinone hydrochloride; AHR-619 Related Compound B
EINECS	Contact for details

Quality Control

Our Doxapram Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and water content determination, to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each unit, detailing batch-specific results, and is available upon request to support your regulatory and quality documentation.

Storage

Preserve in the original, 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 kept tightly sealed in a low-humidity environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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