Description

Ertapenem Impurity CAS NO 444057-62-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic drug Ertapenem. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in drug development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Ertapenem API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine batch release testing to ensure product purity meets pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Ertapenem formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Ertapenem.

Basic Information

Product Name	Ertapenem Impurity
CAS No.	444057-62-9
Molecular Formula	C22H25N3O7S
Molecular Weight	475.52 g/mol
Synonyms	(4R,5S,6S)-3-[[(3S,5S)-5-[(3-Carboxyphenyl)carbamoyl]pyrrolidin-3-yl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid; Ertapenem Related Compound; Ertapenem Degradant; Ertapenem Process Impurity; 1-Azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Ertapenem Impurity (CAS 444057-62-9) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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