Latanoprost Free Acid API | Prostaglandin F2α Analog API Manufacturer in India

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Latanoprost (Free Acid Form) API

Latanoprost (Free Acid Form) is the active acid form of latanoprost, a synthetic prostaglandin F2α analogue used primarily in ophthalmology. Latanoprost itself is administered as an ester prodrug and is hydrolyzed in ocular tissues to the biologically active free acid.

The active free acid acts primarily on FP prostanoid receptors, increasing aqueous humor outflow through the uveoscleral pathway and thereby reducing intraocular pressure.

Latanoprost Free Acid API Manufacturer in India

Latanoprost Free Acid is a specialized ophthalmic pharmaceutical ingredient requiring controlled synthesis, purification and stereochemical characterization.

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

Chemical Information

CAS Number: 41639-83-2
Molecular Formula: C23H32O5
Molecular Weight: 388.50 g/mol
Drug Class: Prostaglandin Analogue
Pharmacological Class: Prostaglandin F2α Analogue
Therapeutic Class: Antiglaucoma Agent
Therapeutic Area: Ophthalmology

Mechanism of Action

The latanoprost free acid is a potent FP prostanoid receptor agonist.

Activation of FP receptors increases aqueous humor drainage, particularly through the uveoscleral outflow pathway.

This results in:

  • Increased aqueous humor outflow
  • Reduced intraocular pressure
  • Improved control of ocular hypertension
  • Reduced pressure associated with glaucoma

Pharmaceutical Applications

Latanoprost is primarily used in ophthalmic formulations for:

  • Open-angle glaucoma
  • Ocular hypertension
  • Reduction of elevated intraocular pressure

The free acid is the pharmacologically active species generated from latanoprost following hydrolysis.

Prostaglandin Analogue Characteristics

Latanoprost is a lipid-soluble ester prodrug designed to improve ocular penetration. Following administration, it is hydrolyzed by esterases to latanoprost free acid, which binds to FP receptors.

This prodrug-to-active-metabolite conversion is an important characteristic of the latanoprost pharmacological profile.

Manufacturing Process

Typical manufacture may involve:

  1. Preparation of protected prostaglandin intermediates
  2. Controlled stereoselective synthesis
  3. Introduction of the cyclopentyl and side-chain structures
  4. Functional-group transformations
  5. Purification
  6. Hydrolysis where required to obtain the free acid
  7. Chromatographic purification
  8. Isolation and drying
  9. Stereochemical characterization
  10. Final analytical testing
  11. Controlled packaging

Quality and Analytical Testing

Latanoprost Free Acid API quality evaluation may include:

  • Identification by HPLC
  • Identification by mass spectrometry
  • Assay
  • Related substances
  • Stereochemical purity
  • Diastereomeric impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Specific optical rotation where applicable
  • Chromatographic purity
  • Stability testing

Storage

Latanoprost Free Acid should be stored according to validated stability data and approved product requirements, with appropriate protection from heat, moisture, oxygen and light. Prostaglandin analogues can be sensitive to environmental conditions, making controlled storage important.

Pharmaceutical Research and Development

Latanoprost Free Acid is relevant to research involving:

  • FP prostanoid receptors
  • Prostaglandin pharmacology
  • Glaucoma
  • Ocular hypertension
  • Intraocular pressure regulation
  • Uveoscleral outflow
  • Ophthalmic drug delivery
  • Prostaglandin analogues
  • Antiglaucoma drug development

Latanoprost Free Acid API Summary

Latanoprost (Free Acid Form) is the pharmacologically active acid form of latanoprost, with CAS Number 41639-83-2, molecular formula C23H32O5, and molecular weight 388.50 g/mol. It acts as an FP receptor agonist and increases uveoscleral aqueous humor outflow, making it relevant to the treatment of elevated intraocular pressure.

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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