N-Methyl Scopolamine API Manufacturer in India

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

N-Methyl Scopolamine API

N-Methyl Scopolamine is a quaternary ammonium derivative of scopolamine and an anticholinergic active pharmaceutical ingredient (API). It acts primarily by antagonizing muscarinic acetylcholine receptors and is associated with inhibition of parasympathetic cholinergic activity.

N-Methyl Scopolamine is commonly encountered in pharmaceutical research and as a quaternary scopolamine derivative. The exact salt and hydration state should be specified when defining the pharmaceutical material because these forms can have different molecular weights and physical properties.

N-Methyl Scopolamine API Manufacturer in India

N-Methyl Scopolamine is a specialized antimuscarinic pharmaceutical compound relevant to pharmaceutical formulation development, analytical research and cholinergic pharmacology. Its quaternary ammonium structure gives it physicochemical properties distinct from scopolamine free base.

Chemical Information

CAS Number: 3485-62-9

Molecular Formula: C18H26NO4⁺

Molecular Weight: 320.41 g/mol (cationic form)

Chemical Class: Tropane Alkaloid Derivative

Drug Class: Anticholinergic / Antimuscarinic

Therapeutic Area: Cholinergic Pharmacology / Gastrointestinal / Ophthalmic Research

Molecule Type: Quaternary Ammonium Derivative

Mechanism of Action

N-Methyl Scopolamine acts primarily by blocking muscarinic acetylcholine receptors.

Its pharmacological effects are associated with:

  • Muscarinic receptor antagonism
  • Reduction of parasympathetic cholinergic signaling
  • Decreased smooth-muscle contraction
  • Reduction of glandular secretions
  • Modulation of gastrointestinal and other cholinergic responses

Because it contains a permanent positive charge associated with its quaternary ammonium structure, its distribution across biological membranes differs from that of non-quaternary scopolamine.

Pharmaceutical Applications

N-Methyl Scopolamine is relevant to:

  • Antimuscarinic drug research
  • Cholinergic receptor research
  • Pharmaceutical formulation development
  • Gastrointestinal pharmacology research
  • Smooth-muscle pharmacology
  • Neuropharmacology research
  • Analytical and quality-control research

Anticholinergic Applications

N-Methyl Scopolamine is a useful compound for research involving muscarinic receptor activity and parasympathetic neurotransmission. Its quaternary ammonium character is particularly relevant when investigating compounds with limited penetration across the blood-brain barrier compared with tertiary amine analogues.

Physical Characteristics

N-Methyl Scopolamine and its pharmaceutical salts are generally handled as solid crystalline materials. Because the compound may be supplied in different salt or hydration forms, appearance, water content and molecular weight should be confirmed against the specific material specification.

Manufacturing Process

A controlled N-Methyl Scopolamine manufacturing process may involve:

  1. Preparation of qualified scopolamine starting material
  2. Controlled N-methylation
  3. Reaction monitoring
  4. Conversion to the required salt form
  5. Purification
  6. Crystallization or isolation
  7. Filtration
  8. Controlled drying
  9. Final analytical testing
  10. GMP-compliant packaging

Quality Control Testing

Typical N-Methyl Scopolamine API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Optical rotation
  • Residue on ignition, where applicable
  • Specific impurity profile
  • Particle-size distribution, where applicable
  • Stability testing

Storage

Store N-Methyl Scopolamine in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should be based on validated stability data and the applicable approved specification.

Pharmaceutical Research

N-Methyl Scopolamine is relevant to research involving:

  • Muscarinic acetylcholine receptors
  • Anticholinergic pharmacology
  • Parasympathetic nervous-system signaling
  • Smooth-muscle contraction
  • Gastrointestinal pharmacology
  • Cholinergic receptor antagonists
  • Neuropharmacology
  • Pharmaceutical formulation development
  • Analytical method development

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%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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