Memantine HCl API Manufacturer in India

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Memantine HCl API

Memantine Hydrochloride (Memantine HCl) is an NMDA receptor antagonist used primarily in the management of moderate to severe Alzheimer's disease. It helps regulate excessive glutamatergic activity in the brain by reducing pathological activation of N-methyl-D-aspartate (NMDA) receptors.

Memantine HCl is an important neurological pharmaceutical API used in the manufacture of oral formulations for Alzheimer's disease.

Memantine HCl API Manufacturer in India

Memantine HCl is a specialized CNS pharmaceutical API used in the development and manufacture of medicines for neurodegenerative disorders.

Key quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities and stereochemical purity, according to the applicable API specification.

Chemical Information

CAS Number: 41100-52-1
Molecular Formula: C12H22ClN
Molecular Weight: 215.76 g/mol
Chemical Name: Memantine Hydrochloride
Synonyms: Memantine HCl, 1-Amino-3,5-dimethyladamantane hydrochloride
Drug Class: NMDA Receptor Antagonist
Therapeutic Class: Anti-dementia Agent
Therapeutic Area: Neurology / Psychiatry
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Memantine is a low- to moderate-affinity, uncompetitive NMDA receptor antagonist. It preferentially blocks pathological NMDA receptor activity while allowing normal physiological neurotransmission to continue.

Its pharmacological action helps:

  • Reduce excessive glutamate-mediated stimulation
  • Limit pathological calcium influx
  • Modulate NMDA receptor activity
  • Protect neurons from excessive excitatory stimulation

Pharmaceutical Applications

Memantine HCl API is used in pharmaceutical development for:

  • Moderate to severe Alzheimer's disease
  • Dementia-related pharmaceutical research
  • NMDA receptor pharmacology
  • Neurodegenerative disease research
  • CNS drug development

Memantine may be used alone or in combination with other Alzheimer's disease therapies depending on the pharmaceutical product and clinical indication.

Dosage Form Applications

Memantine HCl is commonly formulated as:

  • Immediate-release tablets
  • Extended-release capsules
  • Oral solutions
  • Other oral pharmaceutical preparations

Physical Characteristics

Memantine Hydrochloride is generally described as a white crystalline powder. Its physical and solid-state characteristics should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Memantine HCl API manufacturing process may involve:

  1. Selection of qualified starting materials
  2. Preparation of adamantane-based intermediates
  3. Controlled chemical synthesis
  4. Introduction of the amino functionality
  5. Purification
  6. Hydrochloride salt formation
  7. Crystallization
  8. Filtration
  9. Controlled drying
  10. Milling or sieving where required
  11. Final analytical testing
  12. Pharmaceutical-grade packaging

Quality Control Testing

Typical Memantine HCl API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Optical purity / stereochemical purity
  • Residue on ignition
  • Particle-size distribution where applicable
  • Stability testing

Storage

Store Memantine HCl API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Pharmaceutical Research

Memantine HCl is relevant to research involving:

  • NMDA receptors
  • Glutamatergic neurotransmission
  • Alzheimer's disease
  • Neurodegeneration
  • Excitotoxicity
  • CNS pharmacology
  • Dementia therapies
  • Neurological drug development

Memantine HCl API Summary

Memantine Hydrochloride is a synthetic NMDA receptor antagonist with CAS Number 41100-52-1, molecular formula C12H22ClN, and molecular weight 215.76 g/mol. It is primarily used in pharmaceutical formulations for the management of moderate to severe Alzheimer's disease.

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%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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