Description

Ertapenem Impurity Dipp 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.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Dipp-related impurities in Ertapenem active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard in routine QC testing to ensure every batch of Ertapenem meets stringent purity specifications.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability protocols.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria and control strategies.
• Research & Process Chemistry: Used by chemists to study the formation pathways of this impurity, aiding in the optimization of synthesis and purification processes to minimize its presence.

Basic Information

Product Name	Ertapenem Impurity Dipp
CAS No.	220031-86-7
Molecular Formula	C22H30N4O7S
Molecular Weight	494.56 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 Diketo Piperazine (DIPP); Ertapenem DPP Impurity; Ertapenem Related Compound D; Ertapenem Degradation Product; 1-Azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Our Ertapenem Impurity Dipp is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment and allowed to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
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.