Description

Ertapenem Disodium is a synthetic, broad-spectrum carbapenem antibiotic belonging to the β-lactam class. It is valued for its stability against many β-lactamases, making it a critical agent for treating serious polymicrobial and resistant infections. This active pharmaceutical ingredient (API) is primarily required by pharmaceutical manufacturers for the formulation of injectable antibacterial drugs. Ertapenem Disodium CAS NO 153832-38-3 is a key component in the global fight against complex hospital and community-acquired infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of sterile injectable antibiotic formulations.
• Hospital Infection Treatment: Used in drugs targeting complicated intra-abdominal infections, skin and skin structure infections, and community-acquired pneumonia.
• Surgical Prophylaxis: Incorporated into medications for preventing post-surgical infections, particularly in colorectal procedures.
• Complicated Urinary Tract Infections (cUTI): A key therapeutic agent for drug formulations treating resistant urinary tract infections.
• Diabetic Foot Infections: Used in antibiotic preparations for managing polymicrobial infections without osteomyelitis.
• Generic Drug Manufacturing: Serves as the core API for companies producing generic versions of branded ertapenem products.
• Research & Development: Utilized in preclinical and clinical studies for developing new antibacterial therapies and combination drugs.
• Veterinary Pharmaceuticals: Potential application in developing advanced antibacterial treatments for veterinary use.

Basic Information

Item	Detail
Product Name	Ertapenem Disodium
CAS No.	153832-38-3
Molecular Formula	C22H24N3NaO7S
Molecular Weight	497.50 g/mol
Synonyms	Ertapenem Sodium; (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 Disodium Salt; MK-0826; L-749,345; INN: Ertapenem; IUPAC: Disodium (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-carboxylate
EINECS	Contact for details

Quality Control

Our Ertapenem Disodium is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure compliance with ICH Q7 guidelines and relevant pharmacopeial standards for active pharmaceutical ingredients. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We are committed to supplying material suitable for GMP manufacturing processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified. This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
pH (1% Solution)	6.5 - 8.5
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Bacterial Endotoxins	< 0.17 EU/mg
Sterility (for sterile grade)	Sterile

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