Description

Ertapenem Impurity CAS NO 444057-65-2 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 laboratories, and research institutions involved in drug development and impurity profiling. The availability of this well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of 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 and stability testing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Ertapenem drug substances and products comply with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles, specifications, and control strategies for drug approval.
• Research & Development: Serves as a key reagent in metabolic studies, degradation pathway elucidation, and the synthesis of related substances for further investigation.

Basic Information

Product Name	Ertapenem Impurity
CAS No.	444057-65-2
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 Degradation Product; Ertapenem Process Impurity; (4R,5S,6S)-3-[[(3S,5S)-5-[(3-Carboxybenzoyl)amino]pyrrolidin-3-yl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Ertapenem Impurity is manufactured under strict quality systems to ensure batch-to-batch consistency and traceability. Each lot undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes data on assay, related substances, residual solvents, and other critical parameters. Our quality commitment aligns with ICH guidelines and supports compliance requirements for pharmaceutical development and manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or Certificate of Analysis. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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