Meclizine API Manufacturer & Supplier in India

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

Meclizine API Manufacturer in India

Meclizine is a piperazine-class antihistamine with anticholinergic and antiemetic properties. It is primarily used for the prevention and treatment of motion sickness and for the management of vertigo associated with vestibular disorders.

Meclizine works by reducing the effects of histamine at H1 receptors and decreasing abnormal stimulation of the vestibular system. Its central nervous system activity contributes to its antiemetic and antivertigo effects.

Meclizine Chemical Properties

Meclizine is a synthetic first-generation antihistamine with the molecular formula C25H27ClN2 and a molecular weight of approximately 390.95 g/mol. Its CAS Number is 73-33-4.

The compound is commonly supplied in pharmaceutical formulations as meclizine hydrochloride, depending on the intended product and market.

Mechanism of Action

Meclizine acts primarily as an H1 histamine receptor antagonist. It also exhibits anticholinergic activity.

By reducing histaminergic and cholinergic signaling within vestibular pathways, meclizine helps reduce symptoms such as nausea, vomiting and dizziness associated with motion sickness and vestibular disorders.

Pharmaceutical Applications

Meclizine is used for:

  • Prevention and treatment of motion sickness
  • Management of nausea and vomiting associated with motion sickness
  • Symptomatic treatment of vertigo
  • Vestibular disorder-related dizziness

It is generally administered orally.

Meclizine API Characteristics

  • Active Pharmaceutical Ingredient
  • First-Generation H1 Antihistamine
  • Antiemetic Agent
  • Antivertigo Agent
  • CAS Number: 73-33-4
  • Molecular Formula: C25H27ClN2
  • Molecular Weight: 390.95 g/mol
  • Therapeutic Category: Antihistamine / Antiemetic
  • Pharmacological Class: H1 Histamine Receptor Antagonist
  • Primary Target: Histamine H1 Receptor
  • Additional Activity: Anticholinergic
  • Route of Administration: Oral
  • Drug Type: Small-Molecule Pharmaceutical

Meclizine Quality and Analytical Testing

Meclizine API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.

HPLC, infrared spectroscopy and other validated analytical techniques may be used for identity, assay and purity determination. Final acceptance criteria should follow the applicable manufacturer's approved drug-substance specification and Certificate of Analysis.

Meclizine Storage

Meclizine should be stored in a tightly closed pharmaceutical-grade container under controlled conditions and protected from excessive heat, moisture and direct light.

Specific storage and transportation conditions should follow the applicable manufacturer's approved specification.

Meclizine API Supply

Meclizine API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable regulatory and quality requirements.

Meclizine API Manufacturer and Supplier in India

Meclizine API is available for qualified pharmaceutical development and manufacturing requirements. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.

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 10 ppm
pH (1% Solution) 4.0 – 6.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 2.0%
Melting Point Approximately 214–220 °C
Get Bulk Quote via WhatsApp