Mecloxamine Citrate API Manufacturer in India

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Mecloxamine Citrate API

Mecloxamine Citrate is an antihistamine pharmaceutical ingredient belonging to the class of H1 receptor antagonists. It has been used for its antihistaminic and antiemetic properties and is associated with the management of allergic symptoms and motion-related nausea.

Mecloxamine Citrate API Manufacturer in India

Mecloxamine Citrate is a specialized pharmaceutical API used in the development and manufacture of antihistamine and antiemetic formulations.

Important quality attributes include identity, assay, related substances, water content, residual solvents, residue on ignition and elemental impurities, according to the applicable API specification.

Chemical Information

CAS Number: 1218-56-6
Molecular Type: Synthetic Small Molecule
Drug Class: H1 Antihistamine
Therapeutic Class: Antihistamine / Antiemetic
Therapeutic Area: Allergy / Gastroenterology
Molecule Type: Synthetic Compound

Mechanism of Action

Mecloxamine acts primarily as an H1 histamine receptor antagonist. By reducing histamine-mediated signaling, it can suppress certain allergic responses.

Its pharmacological activity is associated with:

  • H1 histamine receptor antagonism
  • Reduction of histamine-mediated effects
  • Antihistaminic activity
  • Antiemetic activity

Pharmaceutical Applications

Mecloxamine Citrate has been associated with pharmaceutical applications involving:

  • Allergic symptoms
  • Histamine-mediated reactions
  • Nausea and vomiting
  • Motion-related sickness
  • Antihistamine formulations
  • Antiemetic pharmaceutical research

Dosage Form Applications

Depending on the applicable pharmaceutical product, Mecloxamine Citrate may be incorporated into:

  • Oral tablets
  • Capsules
  • Oral pharmaceutical preparations

Physical Characteristics

Mecloxamine Citrate is handled as a solid pharmaceutical substance. Its exact appearance, particle characteristics and solid-state properties should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Mecloxamine Citrate manufacturing process may involve:

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

Quality Control Testing

Typical API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Particle-size distribution, where applicable
  • Microbial quality, where applicable
  • Stability testing

Storage

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

Pharmaceutical Research

Mecloxamine Citrate is relevant to research involving:

  • Histamine H1 receptors
  • Antihistamine pharmacology
  • Antiemetic agents
  • Motion sickness
  • Allergy-related pharmacology
  • Gastrointestinal pharmacology
  • Pharmaceutical formulation development

Mecloxamine Citrate API Summary

Mecloxamine Citrate is a synthetic H1 antihistamine pharmaceutical ingredient associated with antihistaminic and antiemetic activity. It has CAS Number 1218-56-6 and has been used in pharmaceutical applications involving allergic symptoms and nausea-related conditions.

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 1.0%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 1.0%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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