Homatropine Methylbromide API Manufacturer in India

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Homatropine Methylbromide API Manufacturer in India

Homatropine Methylbromide is a synthetic anticholinergic and antimuscarinic pharmaceutical ingredient derived from the tropane alkaloid family. It is the methyl bromide quaternary ammonium salt of homatropine and produces antimuscarinic effects by competitively inhibiting acetylcholine at muscarinic receptors.

Homatropine Methylbromide has the molecular formula C17H24BrNO3 and a molecular weight of 370.28 g/mol. Its CAS Number is 80-40-0.

Homatropine Methylbromide API Overview

Homatropine Methylbromide is a quaternary ammonium antimuscarinic compound. The permanent positive charge of its quaternary ammonium group limits its penetration across the blood-brain barrier compared with tertiary amine anticholinergic compounds.

It has historically been used for its antispasmodic and anticholinergic properties and has applications in pharmaceutical formulation and analytical research.

Mechanism of Action

Homatropine Methylbromide acts as a competitive antagonist at muscarinic acetylcholine receptors.

By inhibiting muscarinic receptor stimulation, it can reduce parasympathetic effects such as:

  • Smooth-muscle contraction
  • Gastrointestinal motility
  • Glandular secretions
  • Certain visceral spasms

Pharmaceutical Applications

Homatropine Methylbromide has applications in:

  • Anticholinergic pharmaceutical research
  • Antispasmodic formulation development
  • Gastrointestinal pharmaceutical research
  • Pharmaceutical analytical testing
  • Formulation development
  • Research and development of muscarinic receptor antagonists

API Manufacturing

Homatropine Methylbromide is produced through controlled chemical synthesis involving preparation of the homatropine component followed by quaternization with a methylating agent to form the methyl bromide salt.

The resulting material undergoes purification, drying and quality-control testing to meet the applicable specification.

Physical and Chemical Properties

Homatropine Methylbromide is generally described as a white crystalline powder or crystalline solid. As a quaternary ammonium bromide salt, it has appreciable water solubility compared with the corresponding free-base/tertiary amine form.

Storage

Store Homatropine Methylbromide in a tightly closed container, protected from excessive moisture, heat and direct light. Follow the manufacturer's current CoA, SDS and validated stability conditions.

Quality Documentation

Depending on grade and intended application, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product specification
  • Analytical test report
  • Residual-solvent information
  • Stability information
  • Regulatory documentation

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 2.0%
Residue on Ignition NMT 0.5%
pH (1% Solution) 5.0 – 8.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
Specific Rotation −20° to −30°
Melting Point Approximately 250°C (decomposition)
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