Description

Ertapenem Impurity Pro-Maba 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 drug Ertapenem. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development and validation. The precise characterization of such impurities is essential for meeting stringent pharmacopeial standards and regulatory filings.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pro-Maba impurity in Ertapenem API and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Ertapenem, supporting compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products in Ertapenem under various stress conditions.
• Research & Development: Facilitates studies on the degradation pathways, synthesis, and chemical behavior of Ertapenem and related β-lactam antibiotics.

Basic Information

Item	Details
Product Name	Ertapenem Impurity Pro-Maba
CAS No.	724700-26-9
Molecular Formula	C22H27N5O7S2
Molecular Weight	545.61 g/mol
Synonyms	(4R,5S,6S)-3-[[(3S,5S)-5-[[(3-Carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid; Ertapenem Impurity 4; Ertapenem Related Compound Pro-Maba; Pro-Maba Derivative of Ertapenem; (4R,5S,6S)-3-{[(3S,5S)-5-[(3-Carboxyanilino)carbonyl]-3-pyrrolidinyl]sulfanyl}-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Ertapenem Impurity Pro-Maba is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC). A detailed Certificate of Analysis (COA) is provided, documenting batch-specific results for purity, impurities, and other critical parameters, supporting compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Due to its hygroscopic nature, the material should be stored in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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