Nicergoline API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Nicergoline API

Nicergoline is a semi-synthetic ergoline derivative used as a pharmaceutical active ingredient. It is structurally related to ergot alkaloids and is characterized by activity involving alpha-adrenergic and serotonergic receptors.

Nicergoline is used in pharmaceutical development, particularly in products associated with cerebrovascular and peripheral vascular applications.

Nicergoline API Manufacturer in India

Nicergoline is a specialized pharmaceutical API with defined chemical, stereochemical and physicochemical characteristics. Quality evaluation includes identification, assay, related substances, water content, sulfated ash and optical rotation.

Chemical Information

CAS Number: 27848-84-6

Molecular Formula: C24H26BrN3O3

Molecular Weight: 484.40 g/mol

IUPAC Name: [(6aR,9R,10aS)-10a-methoxy-4,7-dimethyl-6a,8,9,10-tetrahydro-6H-indolo[4,3-fg]quinolin-9-yl]methyl 5-bromopyridine-3-carboxylate

Drug Class: Ergot Derivative

Therapeutic Area: Neurology / Vascular Medicine

Molecule Type: Semi-synthetic Small Molecule

PubChem confirms CAS 27848-84-6, formula C24H26BrN3O3 and molecular weight 484.4 g/mol.

Mechanism of Action

Nicergoline is an ergot-derived compound with pharmacological activity at several receptor systems.

Its pharmacological properties include:

  • Alpha-adrenergic receptor antagonism
  • Modulation of serotonergic neurotransmission
  • Effects on cerebral vascular function
  • Effects on peripheral vascular function
  • Modulation of vascular tone
  • Investigation in cerebrovascular pharmacology

Pharmaceutical Applications

Nicergoline API is used in pharmaceutical development for:

  • Cerebrovascular pharmaceutical formulations
  • Peripheral vascular disease research
  • Neurological drug development
  • Cerebral circulation research
  • Vascular pharmacology research
  • Pharmaceutical formulation development
  • Analytical and quality-control testing

Physical Characteristics

According to the BP 2025 monograph, Nicergoline occurs as a fine to granular, white or yellowish powder. It is practically insoluble in water, freely soluble in methylene chloride and soluble in ethanol (96%). Nicergoline also exhibits polymorphism.

Manufacturing Process

A controlled Nicergoline API manufacturing process may involve:

  • Qualified starting-material preparation
  • Preparation of ergoline intermediates
  • Bromonicotinic acid derivative preparation
  • Esterification
  • Purification
  • Crystallization
  • Filtration
  • Drying
  • Milling, where required
  • Final analytical testing
  • Controlled pharmaceutical packaging

Quality Control Testing

Nicergoline quality testing can include:

  • IR identification
  • UV-visible identification
  • Specific optical rotation
  • HPLC related-substances testing
  • Assay
  • Water determination
  • Sulfated ash
  • Appearance of solution
  • Residual solvents
  • Elemental impurities
  • Polymorphic characterization

The BP monograph specifies 99.0%–101.0% content on an anhydrous basis, water NMT 0.5%, and sulfated ash NMT 0.1%.

Pharmaceutical Research

Nicergoline is relevant to research involving:

  • Cerebrovascular pharmacology
  • Peripheral vascular pharmacology
  • Ergot derivatives
  • Alpha-adrenergic receptors
  • Serotonergic pathways
  • Cerebral circulation
  • Vascular tone
  • Neurological drug development
  • Analytical pharmaceutical research

Storage

Store Nicergoline API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Actual storage conditions should follow the manufacturer's validated stability data and approved specification.

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 1.2%
Water Content NMT 0.5%
Specific Rotation +4.8° to +5.8°
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