Levallorphan API | Opioid Antagonist API Manufacturer in India

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Levallorphan API

Levallorphan is a synthetic opioid compound belonging to the morphinan family. It acts primarily as an opioid receptor antagonist with mixed agonist-antagonist activity, particularly at the μ-opioid receptor.

Levallorphan has been investigated and used historically in the management of opioid-induced respiratory depression and as an antagonist of opioid effects. Its pharmacological activity is related to its ability to compete with opioid agonists at opioid receptors.

Levallorphan API Manufacturer in India

Levallorphan is a specialized opioid pharmaceutical API requiring controlled chemical synthesis, purification and stringent analytical characterization.

Important quality attributes include identity, assay, related substances, stereochemical purity, water content, residual solvents, elemental impurities and stability.

Chemical Information

CAS Number: 152-02-3
Molecular Formula: C17H23NO
Molecular Weight: 257.37 g/mol
Drug Class: Opioid Antagonist / Mixed Opioid Agent
Pharmacological Class: Opioid Receptor Antagonist
Therapeutic Class: Opioid Antidote / Antagonist
Therapeutic Area: Anesthesiology / Pain Management

Mechanism of Action

Levallorphan interacts with opioid receptors in the central nervous system and can antagonize the effects of opioid agonists.

Its activity can:

  • Compete with opioid agonists at opioid receptors
  • Reduce opioid-mediated central nervous system effects
  • Antagonize opioid-induced respiratory depression
  • Modify opioid analgesic and sedative effects

Its pharmacological profile differs from that of highly selective pure opioid antagonists because levallorphan can exhibit mixed receptor activity.

Pharmaceutical Applications

Levallorphan has historically been used as an opioid antagonist for reversing or reducing certain opioid effects, particularly:

  • Opioid-induced respiratory depression
  • Opioid-related central nervous system depression
  • Antagonism of opioid analgesic effects

Its clinical use has largely been superseded by more widely used opioid antagonists in many settings.

Morphinan Characteristics

Levallorphan is structurally related to morphinan opioid compounds and is the levorotatory stereoisomer associated with its opioid receptor activity.

The stereochemical configuration is important because opioid receptor affinity and pharmacological activity are strongly influenced by molecular stereochemistry.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of morphinan-related intermediates
  2. Controlled chemical synthesis
  3. Stereochemical control
  4. Functional-group transformations
  5. Purification
  6. Crystallization or salt formation where applicable
  7. Filtration
  8. Drying
  9. Milling where required
  10. Final analytical testing
  11. Controlled packaging

Quality and Analytical Testing

Levallorphan API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Mass spectrometry
  • Assay
  • Related substances
  • Stereochemical purity
  • Optical rotation
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Particle-size distribution where required
  • Stability testing

Storage

Levallorphan should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Because it is an opioid-related pharmaceutical substance, storage and handling should also comply with applicable controlled-substance regulations.

Pharmaceutical Research and Development

Levallorphan is relevant to research involving:

  • Opioid receptors
  • μ-opioid receptors
  • Opioid antagonists
  • Opioid-induced respiratory depression
  • Morphinan compounds
  • Opioid pharmacology
  • Pain management
  • Anesthesiology
  • Opioid receptor ligand development
  • CNS pharmacology

Levallorphan API Summary

Levallorphan is a synthetic morphinan opioid receptor antagonist/mixed opioid agent with CAS Number 152-02-3, molecular formula C17H23NO, and molecular weight 257.37 g/mol. It has historically been used to antagonize opioid effects, including opioid-induced respiratory depression.

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%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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