Description

Ertapenem Dimer Iii is a structurally defined impurity and degradation product of the carbapenem antibiotic, ertapenem. Its precise characterization is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) and its final drug formulations. This compound is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, method development, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of ertapenem API and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Stability and Forced Degradation Studies: Employed to identify and quantify degradation pathways of ertapenem under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: Serves as a system suitability component and an identification marker in the routine QC testing of pharmaceutical batches.
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Research on Degradation Mechanisms: Used in academic and industrial research to understand the chemical behavior and stability of carbapenem antibiotics.

Basic Information

Product Name	Ertapenem Dimer Iii
CAS No.	1199797-42-6
Molecular Formula	C34H44N8O12S2
Molecular Weight	820.90 g/mol
Synonyms	(4R,5S,6S)-3-[[(3S,5S)-5-[[(3-Carboxyphenyl)carbamoyl]methyl]-4-methyl-2-oxo-1,3-thiazolidin-3-yl]sulfanyl]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Ertapenem Dimer III; Ertapenem Dimer C; Ertapenem Impurity Dimer III; Ertapenem Related Compound Dimer III
EINECS	Contact for details

Quality Control

Our Ertapenem Dimer Iii is manufactured under controlled conditions 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 HPLC purity, NMR, and MS confirmation. Our quality system is designed to support GMP/GLP compliance for use as a reference standard in pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This material is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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