Description

Ertapenem Impurity 29 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 Ertapenem during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams for method validation, impurity profiling, and stability studies. The availability of this well-characterized impurity standard is essential for maintaining the stringent purity specifications of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ertapenem Impurity 29 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor and control impurity levels in Ertapenem API and finished dosage forms to meet pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Serves as a key intermediate or marker in studies investigating the synthesis, metabolism, or degradation pathways of Ertapenem.

Basic Information

Product Name	Ertapenem Impurity 29
CAS No.	866317-77-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 29; Ertapenem EP Impurity J; Ertapenem USP Impurity 29; Ertapenem Degradant; Ertapenem Process Impurity
EINECS	Contact for details

Quality Control

Our Ertapenem Impurity 29 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance needs.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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