Description

Cefalexin Impurity (3-Aminomethylene-6-Phenylpiperazine-2,5-Dione) is a key chemical reference standard used in the analytical profiling and quality control of the antibiotic Cefalexin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It serves as an essential tool for method development, validation, and impurity identification in the production of high-quality active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Cefalexin API and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish impurity profiles and validate analytical procedures.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to monitor the formation of this specific degradation product in Cefalexin under various storage conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cephalosporin antibiotics.
• Pharmacopoeial Testing: Supports testing in compliance with monographs from USP, EP, BP, and other international pharmacopoeias.

Basic Information

Product Name	Cefalexin Impurity (3-Aminomethylene-6-Phenylpiperazine-2,5-Dione)
CAS No.	65870-51-1
Molecular Formula	C12H13N3O2
Molecular Weight	231.25 g/mol
Synonyms	3-Aminomethylene-6-phenylpiperazine-2,5-dione; Cefalexin Impurity; Cephalexin Related Compound; 6-Phenyl-3-(aminomethylene)piperazine-2,5-dione; Cefalexin Degradation Product; Cephalexin Impurity; (3-Aminomethylene-6-phenyl-2,5-diketopiperazine); 65870-51-1
EINECS	Contact for details

Quality Control

Every batch of our Cefalexin Impurity is manufactured and tested under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis. A Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results and confirming compliance with in-house specifications suitable for use as a reference standard.

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) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment away from direct light exposure 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
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Heavy Metals	≤ 20 ppm

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