Description

Aminoglutethimide Impurity D is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in the active pharmaceutical ingredient (API) aminoglutethimide, ensuring product safety and regulatory compliance. It is primarily used by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries to meet stringent pharmacopeial requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative analysis of aminoglutethimide and its related substances.
• Impurity Profiling & Method Development: Used in the development and validation of analytical methods (e.g., HPLC, LC-MS) for impurity identification and characterization.
• Quality Control & Assurance (QC/QA): Critical for batch release testing of aminoglutethimide API to ensure compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to monitor the formation of degradation products in aminoglutethimide formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study the metabolism and degradation pathways of aminoglutethimide.

Basic Information

Product Name	Aminoglutethimide Impurity D
CAS No.	119229-88-8
Molecular Formula	C13H16N2O2
Molecular Weight	232.28 g/mol
Synonyms	3-(4-Aminophenyl)-3-ethylpiperidine-2,6-dione; 4-Amino Analog of Aminoglutethimide; 4-Aminoaminoglutethimide; Aminoglutethimide 4'-Amino Impurity; Aminoglutethimide Related Compound D; AG Impurity D; 4'-Amino-3-ethyl-3-(4-aminophenyl)piperidine-2,6-dione
EINECS	Contact for details

Quality Control

Every batch of Aminoglutethimide Impurity D is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to support pharmaceutical applications, with testing typically performed in accordance with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity levels is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material should be handled in accordance with good laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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