Methylergonovine is a semi-synthetic ergot alkaloid and a potent uterotonic agent. It acts directly on uterine smooth muscle to increase the tone, rate, and amplitude of uterine contractions. Methylergonovine is commonly supplied pharmaceutically as methylergonovine maleate.
Methylergonovine maleate is used for the prevention and control of postpartum hemorrhage by promoting sustained uterine contraction following childbirth.
Methylergonovine Maleate is a specialized obstetric and gynecological pharmaceutical API requiring strict control of identity, assay, related alkaloids, optical rotation, pH, loss on drying and residue on ignition.
CAS Number: 57432-61-8 — Methylergonovine Maleate
Molecular Formula: C20H25N3O2 · C4H4O4
Molecular Weight: 455.50 g/mol
Free Methylergonovine Formula: C20H25N3O2
Free Methylergonovine Molecular Weight: 339.43 g/mol
Drug Class: Ergot Alkaloid
Therapeutic Class: Uterotonic Agent
Therapeutic Area: Obstetrics / Gynecology
Molecule Type: Semi-synthetic Ergot Alkaloid
Methylergonovine acts directly on uterine smooth muscle, increasing uterine tone and the rate and amplitude of rhythmic contractions. This produces a rapid and sustained uterotonic effect.
Methylergonovine Maleate API is used in pharmaceutical applications involving:
Methylergonovine Maleate is used in:
The USP describes Methylergonovine Maleate Injection as a sterile solution containing 0.2 mg/mL methylergonovine maleate.
Methylergonovine Maleate is handled as a pharmaceutical salt. The USP specifies preservation in tight, light-resistant containers and storage in a cold place.
A controlled Methylergonovine Maleate API manufacturing process may involve:
USP monograph information provides numerical requirements for several important quality parameters, including assay, optical rotation, pH, loss on drying and residue on ignition.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0%–103.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 4.4–5.2 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |