Ergometrine API Manufacturer & Supplier in India

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Ergometrine API Manufacturer & Supplier in India

Ergometrine, also known as Ergonovine, is a naturally derived ergot alkaloid with potent uterotonic activity. It is used in pharmaceutical formulations to promote uterine contraction, particularly in the management of postpartum bleeding associated with uterine atony.

Ergometrine is an ergot alkaloid structurally related to lysergic acid derivatives. It acts primarily on serotonergic, dopaminergic and adrenergic receptors, producing contraction of uterine smooth muscle and increasing uterine tone.

What is Ergometrine?

Ergometrine is the active pharmaceutical ingredient used in pharmaceutical preparations requiring controlled uterotonic activity. It is commonly encountered as ergometrine maleate, the salt form used in medicinal products.

The molecular formula of ergometrine is C₁₉H₂₃N₃O₂, with a molecular weight of approximately 325.41 g/mol. The CAS Registry Number for ergometrine is 60-79-7.

Mechanism of Action

Ergometrine produces contraction of uterine smooth muscle by interacting with several neurotransmitter receptors, particularly 5-HT2 serotonin receptors, as well as α-adrenergic and dopamine receptors.

Its uterotonic activity increases the tone and contraction of the uterus, making it useful in controlling bleeding associated with inadequate uterine contraction following childbirth.

Pharmaceutical Applications

Ergometrine is primarily associated with:

  • Postpartum haemorrhage management
  • Prevention and treatment of uterine atony
  • Control of postpartum bleeding
  • Uterotonic pharmaceutical formulations
  • Obstetric pharmaceutical applications

Ergometrine API

Ergometrine is a small-molecule ergot alkaloid API. Pharmaceutical-grade material is characterized using appropriate identity, assay, purity, related-substances and physicochemical testing.

Ergometrine maleate is commonly used in finished pharmaceutical formulations because the salt provides a suitable form for pharmaceutical manufacture.

Quality & Regulatory Considerations

Ergometrine API intended for pharmaceutical manufacturing should comply with the applicable pharmacopoeial monograph and approved product specification. Quality evaluation may include identification, assay, related substances, water content, optical rotation, residual solvents and other applicable physicochemical parameters.

A qualified supplier should provide relevant Certificate of Analysis (CoA), specification documentation, Safety Data Sheet (SDS/MSDS), batch traceability and regulatory documentation.

Storage

Ergometrine and its pharmaceutical preparations should be protected from light, moisture and excessive heat and stored according to the applicable approved specification and stability requirements.

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%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point 150°C – 154°C
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