Methdilazine API Manufacturer in India

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Methdilazine API

Methdilazine is a first-generation antihistamine belonging to the phenothiazine class. It possesses antihistaminic and anticholinergic properties and has been used primarily for the relief of itching associated with various dermatological conditions. PubChem identifies methdilazine as a histamine antagonist, cholinergic antagonist and antipruritic compound.

Methdilazine is a synthetic pharmaceutical compound relevant to antihistamine, dermatology and pharmaceutical research.

Methdilazine API Manufacturer in India

Methdilazine is a specialized antihistamine API used in pharmaceutical development and formulation. Quality evaluation should include identity, assay, related substances, residual solvents, water content and other applicable pharmaceutical quality parameters.

Chemical Information

CAS Number: 1982-37-2
Molecular Formula: C18H20N2S
Molecular Weight: 296.43 g/mol
IUPAC Name: 10-[(1-Methylpyrrolidin-3-yl)methyl]phenothiazine
Drug Class: First-Generation Antihistamine
Chemical Class: Phenothiazine
Therapeutic Class: Antihistamine / Antipruritic
Therapeutic Area: Dermatology / Allergy
Molecule Type: Synthetic Small Molecule

The CAS number, molecular formula and molecular weight are confirmed by NIST and the Royal Society of Chemistry's Merck Index.

Mechanism of Action

Methdilazine acts primarily as a histamine H1 receptor antagonist, reducing the effects of histamine involved in allergic reactions and itching.

It also possesses anticholinergic activity, which contributes to its broader pharmacological effects.

Pharmaceutical Applications

Methdilazine is associated with:

  • Relief of pruritus
  • Allergic skin conditions
  • Dermatological disorders associated with itching
  • Antihistamine research
  • Antipruritic pharmaceutical development
  • Histamine receptor pharmacology

Dosage Form Applications

Methdilazine has historically been used in oral pharmaceutical preparations, including tablets and other formulations depending on the applicable market.

Physical Characteristics

Methdilazine is described as a crystalline solid.

Manufacturing Process

A controlled Methdilazine API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of phenothiazine intermediates
  3. Controlled N-substitution
  4. Introduction of the methylpyrrolidinylmethyl side chain
  5. Purification
  6. Crystallization
  7. Filtration
  8. Controlled drying
  9. Final analytical testing
  10. Pharmaceutical-grade packaging

Quality Control Testing

Typical testing may include:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Melting point
  • Stability testing

Storage

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

Pharmaceutical Research

Methdilazine is relevant to research involving:

  • Histamine H1 receptors
  • Antihistamine pharmacology
  • Phenothiazine compounds
  • Anticholinergic activity
  • Dermatological therapeutics
  • Pruritus
  • Allergy research
  • Antipruritic drug development

Methdilazine API Summary

Methdilazine is a phenothiazine-class first-generation antihistamine with anticholinergic properties. It has CAS Number 1982-37-2, molecular formula C18H20N2S, and molecular weight 296.43 g/mol.

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 ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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