Ertapenem API Manufacturer & Supplier in India

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Ertapenem API Manufacturer & Supplier in India

Ertapenem is a synthetic 1-beta-methyl carbapenem antibiotic belonging to the beta-lactam class. It has broad-spectrum antibacterial activity and is used in pharmaceutical formulations for the treatment of susceptible bacterial infections.

Ertapenem inhibits bacterial cell-wall synthesis by binding to penicillin-binding proteins (PBPs), thereby interfering with the final transpeptidation step required for peptidoglycan synthesis. This results in bacterial cell-wall disruption and bactericidal activity.

What is Ertapenem?

Ertapenem is a carbapenem antibacterial API with activity against a broad range of Gram-positive and Gram-negative aerobic and anaerobic bacteria. It is structurally related to other carbapenem antibiotics such as meropenem, imipenem and doripenem.

Ertapenem has the molecular formula C₂₂H₂₅N₃O₇S, molecular weight 475.5 g/mol, and CAS Registry Number 153832-46-3.

Mechanism of Action

Ertapenem exerts bactericidal activity by binding to bacterial penicillin-binding proteins (PBPs) and inhibiting the synthesis of peptidoglycan, an essential component of the bacterial cell wall.

This mechanism leads to:

  • Inhibition of bacterial cell-wall synthesis
  • Disruption of bacterial cell-wall integrity
  • Bacterial cell lysis
  • Bactericidal antibacterial activity

Pharmaceutical Applications

Ertapenem is associated with pharmaceutical treatment of susceptible bacterial infections, including certain:

  • Intra-abdominal infections
  • Complicated skin and skin-structure infections
  • Community-acquired pneumonia
  • Complicated urinary tract infections
  • Acute pelvic infections
  • Other susceptible bacterial infections

The exact approved indications depend on the applicable regulatory labeling.

Ertapenem API

Ertapenem is a carbapenem beta-lactam API. In commercial pharmaceutical products, it is commonly supplied as ertapenem sodium, the sodium salt of ertapenem. PubChem identifies Ertapenem Sodium as the sodium salt and lists a molecular weight of approximately 497.5 g/mol.

Quality & Regulatory Considerations

Pharmaceutical-grade Ertapenem should be evaluated using validated analytical methods appropriate for a carbapenem antibiotic. Important quality attributes may include:

  • Identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Sterility/endotoxin controls where applicable
  • Beta-lactam degradation products
  • Elemental impurities
  • Microbial quality

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Ertapenem should be stored according to the approved API specification and stability requirements, with appropriate protection from moisture, heat and other conditions that may promote beta-lactam degradation.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point 150°C – 154°C
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