Misoprostol (Methyl Ester) API Manufacturer in India

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Misoprostol (Methyl Ester) API

Misoprostol (Methyl Ester) is a synthetic prostaglandin E1 (PGE1) analogue and is the methyl ester form of misoprostol. It belongs to the prostaglandin-class compounds and is used primarily as a pharmacological research compound and reference material.

The compound is associated with prostaglandin receptor pharmacology and has been studied for its activity at EP prostanoid receptors. The methyl ester structure gives the molecule a molecular formula of C22H38O5 and a molecular weight of approximately 382.5 g/mol.

Misoprostol (Methyl Ester) API Manufacturer in India

Misoprostol (Methyl Ester) is a specialized prostaglandin pharmaceutical compound requiring stringent control of chemical identity, stereochemical composition, purity and related substances.

Because misoprostol contains multiple stereocenters and exists as stereoisomeric components, stereochemical purity and isomeric composition are important quality attributes.

Chemical Information

ParameterValue
Product NameMisoprostol (Methyl Ester)
CAS Number59122-46-2
Molecular FormulaC22H38O5
Molecular Weight382.5 g/mol
IUPAC NameMethyl 7-[(1R,2R,3R)-3-hydroxy-2-[(S,E)-4-hydroxy-4-methyloct-1-enyl]-5-oxocyclopentyl]heptanoate
Compound ClassProstaglandin E1 Analogue
Therapeutic AreaGastroenterology / Reproductive Pharmacology
Molecule TypeSynthetic Small Molecule

PubChem identifies 59122-46-2 as the CAS number for the principal misoprostol structure and reports the molecular formula as C22H38O5.

Mechanism of Action

Misoprostol is a prostaglandin E1 analogue that interacts with prostanoid receptors. Its pharmacological effects are associated with modulation of prostaglandin receptor signaling.

Misoprostol-related pharmacology includes:

  • Prostanoid receptor activation
  • Modulation of gastric acid secretion
  • Enhancement of gastric mucosal protection
  • Smooth-muscle effects
  • Uterotonic activity

The methyl ester compound itself should be distinguished from the pharmacologically active misoprostol preparation and from individual stereoisomers when describing regulatory or clinical applications.

Pharmaceutical and Research Applications

Misoprostol-related compounds are associated with:

  • Prostaglandin receptor research
  • Gastrointestinal pharmacology
  • Gastric mucosal protection research
  • Reproductive pharmacology
  • Smooth-muscle pharmacology
  • Prostaglandin analogue research
  • Pharmaceutical analytical research

Physical Characteristics

Misoprostol (Methyl Ester) is a lipophilic prostaglandin derivative. IUPHAR/BPS reports a molecular weight of 382.27 g/mol, XlogP of 3.57, topological polar surface area of 83.83 Ų, five hydrogen-bond acceptors and two hydrogen-bond donors.

Manufacturing Process

A controlled manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of the prostaglandin intermediate
  3. Controlled stereoselective synthesis
  4. Esterification / methyl ester formation
  5. Purification
  6. Isomer separation or enrichment where required
  7. Chromatographic purification
  8. Solvent removal
  9. Controlled drying
  10. Final analytical characterization
  11. Pharmaceutical-grade packaging

Quality Control Testing

Important analytical parameters include:

  • Identity by IR
  • HPLC identification
  • LC-MS confirmation
  • Assay
  • Related substances
  • Stereochemical purity
  • Isomeric impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Stability-indicating purity testing

Storage

Store in a tightly closed container under controlled conditions, protected from moisture, excessive heat and direct light. Exact temperature requirements should follow the validated stability data for the material.

Pharmaceutical Research

Misoprostol (Methyl Ester) is relevant to research involving:

  • Prostaglandin E analogues
  • EP prostanoid receptors
  • Gastric mucosal protection
  • Gastric acid regulation
  • Smooth-muscle pharmacology
  • Reproductive pharmacology
  • Prostaglandin medicinal chemistry
  • Analytical reference standards

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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