Description

Ertapenem Dimer Form D Impurity is a specified impurity of the carbapenem antibiotic ertapenem, identified by the CAS registry number 1199797-41-5. This compound is critical for pharmaceutical research and development, serving as a reference standard for the identification, quantification, and control of dimeric impurities during the manufacturing and quality assurance of ertapenem active pharmaceutical ingredient (API). It is primarily needed by analytical laboratories, quality control units, and regulatory affairs departments within pharmaceutical companies and contract research organizations (CROs) to ensure drug purity, safety, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ertapenem Dimer Form D in drug substances and products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control and Batch Release: Employed in routine QC testing to monitor and control the level of this specific dimer impurity to ensure it remains within International Council for Harmonisation (ICH) specified limits.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Optimization: Helps chemists identify and mitigate the formation pathways of this dimer during API synthesis and purification process development.

Basic Information

Product Name	Ertapenem Dimer Form D Impurity
CAS No.	1199797-41-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R,4R,5R,8R)-3-[(2S,3S)-2-[[(3S,5S)-5-[(3-Carboxy-1-azetidinyl)carbonyl]-3-pyrrolidinyl]thio]-3-hydroxy-1-oxobutyl]-4-[(1R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Ertapenem Dimer D; Ertapenem Dimer Form D; Ertapenem Dimer Impurity D; Ertapenem Related Compound D (Dimer)
EINECS	Contact for details

Quality Control

Our Ertapenem Dimer Form D Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and water content determination, to ensure it meets the high standards required for use as a reference standard. Certificates of Analysis (COA) with detailed batch-specific results are provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.