Description

Aceglutamide Impurity CAS NO 1468-52-6 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Aceglutamide, a pharmaceutical agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Aceglutamide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial monographs (e.g., USP, EP).
• Stability Studies: Acts as a marker to track degradation pathways and assess the shelf-life of Aceglutamide formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Utilized in synthetic chemistry research to study the formation, isolation, and characterization of process-related impurities during Aceglutamide synthesis.

Basic Information

Product Name	Aceglutamide Impurity
CAS No.	1468-52-6
Molecular Formula	C7H12N2O4
Molecular Weight	188.18 g/mol
Synonyms	L-2-Acetamido-4-carbamoylbutanoic acid; N2-Acetyl-L-glutamine; N-Acetyl-L-glutamine; N-Acetylglutamine; Aceglutamide Related Compound; Aceglutamide Impurity A; L-Glutamine, N-acetyl-; (S)-2-Acetamidopentanediamide
EINECS	Contact for details

Quality Control

Our Aceglutamide Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC, NMR, and MS. We support compliance with ICH guidelines and can provide materials suitable for use as pharmaceutical reference standards.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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