Penamecillin API Manufacturer in India

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Penamecillin API Overview

Penamecillin is a semisynthetic penicillin derivative and an acetoxymethyl ester prodrug of benzylpenicillin (penicillin G). It belongs to the beta-lactam penicillin class of antibacterial compounds. Penamecillin is chemically classified as a penicillanic acid ester and is converted by esterases to benzylpenicillin, the pharmacologically active antibacterial agent.

Penamecillin has the CAS Number 983-85-7, molecular formula C19H22N2O6S, and molecular weight 406.45 g/mol. FDA GSRS identifies the substance under UNII H0P1YE5581, while ChEBI, ChEMBL and DrugBank provide additional chemical and pharmaceutical identifiers.

The compound is also known by several names, including Penamecillinum, Penamecillina, benzylpenicillin acetoxymethyl ester, acetoxymethyl benzylpenicillinate, and the development code WY-20788. It has been associated with the trade names Havapen and Maripen in historical pharmaceutical literature.

Chemical Structure of Penamecillin

Penamecillin is structurally related to benzylpenicillin. Its chemical structure contains the characteristic beta-lactam ring and thiazolidine ring of penicillin derivatives, together with an acetoxymethyl ester group.

Its systematic chemical name is:

Acetyloxymethyl (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

PubChem confirms three defined stereocenters and the molecular formula C19H22N2O6S.

Key Chemical Information

  • Product: Penamecillin
  • CAS Number: 983-85-7
  • Molecular Formula: C19H22N2O6S
  • Molecular Weight: 406.45 g/mol
  • Exact Mass: 406.11986 Da
  • UNII: H0P1YE5581
  • ChEBI: CHEBI:131733
  • ChEMBL: CHEMBL2106988
  • DrugBank: DB13739
  • KEGG: D05406
  • ATC: J01CE06
  • Development Code: WY-20788
  • Chemical Class: Penicillanic acid ester
  • Drug Class: Beta-lactam antibacterial
  • Parent Active Drug: Benzylpenicillin

 

Mechanism of Action

Penamecillin itself functions primarily as a prodrug of benzylpenicillin. Following administration, esterases hydrolyze the acetoxymethyl ester portion of the molecule, releasing benzylpenicillin. ChEBI specifically defines penamecillin as the acetoxymethyl ester of benzylpenicillin and identifies it as a prodrug for benzylpenicillin.

The resulting benzylpenicillin exerts its antibacterial action by interfering with bacterial cell-wall synthesis. Like other penicillin-class beta-lactam antibiotics, benzylpenicillin acts on bacterial penicillin-binding proteins and disrupts peptidoglycan cross-linking, ultimately compromising bacterial cell-wall integrity.

This prodrug approach was designed to modify the pharmaceutical and absorption characteristics of the parent penicillin.

Penamecillin Pharmaceutical Development

Penamecillin has been studied as an orally active antibacterial prodrug. Historical pharmacological research investigated its absorption, metabolism and conversion to benzylpenicillin. PubChem classifies it as an antibacterial drug and prodrug, while ChEMBL records pharmaceutical development information for the compound.

Historical literature reports that penamecillin was investigated in relation to oral administration and systemic exposure to benzylpenicillin. It has also been studied in pharmacokinetic research involving the passage of penicillins from mother to fetus.

Because penamecillin is a historical/less commonly used penicillin prodrug rather than a widely marketed contemporary API, its current public regulatory specification information is considerably more limited than that available for major penicillins such as benzylpenicillin, amoxicillin or ampicillin.

Physical and Chemical Properties

Penamecillin is reported as a crystalline solid. Multiple chemical-reference sources report a melting point of approximately 106–108°C.

Historical chemical data also report a specific optical rotation of approximately:

[α]D20 +154°

This value is useful as a physicochemical reference but should not automatically be represented as a current pharmacopoeial acceptance range.

The compound has a calculated XLogP3 value of approximately 2.1, one hydrogen-bond donor, seven hydrogen-bond acceptors and eight rotatable bonds according to PubChem.

Penamecillin Solubility

Public commercial/research sources provide limited and inconsistent quantitative solubility data for Penamecillin. One research supplier reports solubility of approximately 10 mM in DMSO, while other sources do not provide a validated aqueous solubility value.

For this reason, a universal numerical water-solubility specification should not be invented for the CMS API specification.

Penamecillin Purity and Analytical Characterization

Penamecillin is available from research-chemical sources with different batch-specific purity specifications. For example, one commercial research listing reports 99.98% assay/purity, while another commercial source lists material at 96%. These differences demonstrate why commercial research-grade purity should not be presented as a universal pharmaceutical API specification.

Suitable analytical characterization of Penamecillin can include:

  • HPLC assay
  • HPLC related-substance testing
  • LC-MS identification
  • IR spectroscopy
  • NMR characterization
  • Optical rotation
  • Residual-solvent testing
  • Water determination
  • Melting-point determination

A commercial research source specifically provides RP-HPLC, NP-HPLC, LC-MS, MS, IR and other analytical documentation for its Penamecillin material.

Penamecillin API Quality Control

For pharmaceutical or analytical development, important Penamecillin quality attributes can include:

  1. Identity — confirmation of the Penamecillin molecular structure.
  2. Assay — quantitative determination using a validated chromatographic method.
  3. Related substances — control of degradation and process-related impurities.
  4. Water content — monitoring moisture in the beta-lactam compound.
  5. Residual solvents — control of manufacturing solvents.
  6. Optical rotation — useful for stereochemical characterization.
  7. Melting point — useful as a physicochemical identity parameter.
  8. Beta-lactam integrity — important because beta-lactam compounds can undergo hydrolysis.
  9. Stability — monitoring degradation during storage.

However, no current public USP, Ph. Eur. or IP universal Penamecillin API monograph with numerical release limits was verified during this research. Therefore, numerical values such as assay limits, LOD, residue on ignition, heavy-metal limits and impurity limits should not be fabricated.

Penamecillin and Benzylpenicillin

Penamecillin is directly related to benzylpenicillin. Its role is to act as an esterified prodrug that can release benzylpenicillin after enzymatic hydrolysis. The parent drug benzylpenicillin is an established beta-lactam antibacterial, whereas penamecillin represents an esterified form developed to modify pharmaceutical properties.

This relationship makes Penamecillin relevant to:

  • Penicillin prodrug research
  • Beta-lactam antibacterial research
  • Oral prodrug development
  • Benzylpenicillin pharmacokinetic studies
  • Pharmaceutical analytical research
  • Antibiotic structure-activity studies
  • Drug-metabolism research

Penamecillin API Applications

Potential applications of Penamecillin API or reference material include:

  • Penicillin prodrug research
  • Beta-lactam antibiotic research
  • Pharmaceutical analytical development
  • HPLC method development
  • LC-MS characterization
  • Drug metabolism studies
  • Pharmacokinetic research
  • Stability studies
  • Reference-standard development
  • Medicinal chemistry research

Because Penamecillin is not supported by a current publicly verified universal pharmacopoeial API specification, its final pharmaceutical quality requirements should be established from the applicable regulatory dossier, validated analytical procedures and approved product-specific specification.

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 0.5%
Residue on Ignition NMT 0.2%
Individual Impurity NMT 0.5%
Total Impurities ≤ 1.5%
Melting Point 106–108°C
Solubility 106–108°C
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