Description

Ertapenem Impurity 10 is a specified impurity and degradation product of the carbapenem antibiotic, Ertapenem. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, stability studies, and quality control testing. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Ertapenem API and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ertapenem active pharmaceutical ingredient (API) and formulations.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies & Forced Degradation: Employed to understand degradation pathways and establish shelf-life specifications for Ertapenem products.
• Quality Control & Batch Release: Acts as a system suitability standard in QC laboratories to ensure analytical procedures are performing correctly for impurity detection.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research on Degradation Mechanisms: Used in academic and industrial research to study the chemical behavior and stability of carbapenem antibiotics.

Basic Information

Product Name	Ertapenem Impurity 10
CAS No.	357154-27-9
Molecular Formula	C22H24N3NaO7S
Molecular Weight	497.50 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 sodium salt; Ertapenem Related Compound J; Ertapenem Sodium Impurity J; Ertapenem EP Impurity J; Ertapenem USP Impurity J; (4R,5S,6S)-3-[[(3S,5S)-5-[(3-Carboxybenzoyl)amino]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt
EINECS	Contact for details

Quality Control

Our Ertapenem Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances by validated chromatographic methods. The quality standards are aligned with the requirements for pharmaceutical reference materials.

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 Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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