Description

Nmp-Aca (Cefepime Impurity) is a high-purity chemical reference standard used in the analysis and quality control of the antibiotic Cefepime. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Nmp-Aca in Cefepime Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Cefepime batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Cefepime to monitor impurity formation over time and under various stress conditions.
• Research on Degradation Pathways: Aids in research to understand the synthesis and degradation pathways of Cefepime, helping to optimize manufacturing processes.

Basic Information

Product Name	Nmp-Aca (Cefepime Impurity)
CAS No.	103296-32-8
Molecular Formula	C18H20N6O5S2
Molecular Weight	472.52 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino]-3-[(1-methylpyrrolidin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; 1-Methyl-4-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-pyrrolidinium; Cefepime N-Methylpyrrolidine Impurity; Cefepime Impurity A; Cefepime EP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Nmp-Aca (Cefepime Impurity) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.