Pizotifen API Manufacturer in India

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Pizotifen API Manufacturer in India

Pizotifen is a pharmaceutical active ingredient belonging to the serotonin and histamine antagonist class. It is identified by CAS Number 15574-96-6, with the molecular formula C₁₉H₂₁NS and molecular weight 295.4 g/mol. Pizotifen has been used primarily for the prophylaxis of migraine and other vascular headache disorders.

Pizotifen API

Pizotifen API is a small-molecule compound with serotonin-antagonist and antihistamine activity. It acts mainly at serotonin 5-HT receptors, including 5-HT1 and 5-HT2 receptor subtypes, and also exhibits histamine-antagonist activity. It has been used for the prevention of migraine and cluster headache attacks.

The free base form of Pizotifen is identified by CAS 15574-96-6. Pizotifen Maleate is a separate salt form with CAS 24359-22-6, molecular formula C₂₃H₂₅NO₄S, and molecular weight 411.5 g/mol. Pizotifen Malate is another separate salt form, identified by CAS 5189-11-7.

Chemical and Pharmaceutical Profile

Pizotifen has the molecular formula C₁₉H₂₁NS and molecular weight 295.4 g/mol. PubChem reports an exact mass of 295.13947085 Da, XLogP3-AA of 3.8, hydrogen-bond donor count of 0, hydrogen-bond acceptor count of 2, rotatable bond count of 0, and topological polar surface area of 31.5 Ų.

The compound is a benzocycloheptathiophene derivative containing an N-methylpiperidine moiety. It is a non-ionic free-base compound and is associated with antihistaminic, serotonergic-antagonist and weak antimuscarinic pharmacological activity.

Key chemical identifiers include:

  • Product Name: Pizotifen
  • CAS Number: 15574-96-6
  • Molecular Formula: C₁₉H₂₁NS
  • Molecular Weight: 295.4 g/mol
  • UNII: 0BY8440V3N
  • ChEBI: CHEBI:50212
  • EC Number: 239-632-9
  • Physical Form: Powder
  • Exact Mass: 295.13947085 Da
  • XLogP3-AA: 3.8
  • H-Bond Donors: 0
  • H-Bond Acceptors: 2
  • Rotatable Bonds: 0
  • TPSA: 31.5 Ų

Pharmaceutical Applications

Pizotifen is primarily associated with the prophylaxis of migraine and vascular headache. Its pharmacological profile includes serotonin antagonism, particularly at 5-HT receptor subtypes, together with antihistaminic activity.

Pizotifen API may be relevant to:

  • Migraine-prevention pharmaceutical formulations
  • Headache-prophylaxis research
  • Serotonin-receptor pharmacology
  • Antihistamine-related pharmaceutical research
  • API development and characterization
  • Analytical method development
  • Pharmaceutical quality-control testing
  • Stability and impurity studies

Quality and Analytical Testing

Pizotifen API can be characterized using HPLC, LC-MS, NMR, chromatographic purity testing and other suitable analytical techniques.

Sigma-Aldrich currently lists Pizotifen ≥98% by HPLC, in powder form, with DMSO solubility of ≥8 mg/mL and room-temperature storage for its research product. These values relate to the specific analytical/research-grade material and should not be presented as a universal pharmacopoeial API specification.

For pharmaceutical API material, identity, assay, related substances, residual solvents, water content, elemental impurities and other quality attributes should be controlled according to the applicable approved specification and batch-specific Certificate of Analysis.

Pizotifen API Manufacturer in India

Pizotifen API is identified by CAS 15574-96-6, molecular formula C₁₉H₂₁NS, and molecular weight 295.4 g/mol. Its established pharmacological profile and defined chemical identity make it relevant to pharmaceutical development, formulation and analytical applications.

Quality evaluation may include HPLC assay, chromatographic purity, identity testing by spectroscopic techniques and other applicable pharmaceutical quality-control tests.

When supplying or manufacturing Pizotifen API, the free-base form should be clearly distinguished from Pizotifen Maleate and Pizotifen Malate because these salts have different CAS numbers, molecular formulas and molecular weights.

Packaging and Storage

Pizotifen should be packed in tightly closed, suitable pharmaceutical-grade containers that protect the material from moisture, contamination and unsuitable environmental exposure.

Sigma-Aldrich lists its Pizotifen research product for room-temperature storage and reports the material in powder form. Commercial pharmaceutical API storage should follow the approved product specification, packaging configuration and available stability data.

Documentation

Applicable documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • HPLC assay and purity data
  • Related-substance information
  • LC-MS / NMR characterization data
  • Batch analytical results
  • Stability information, where applicable
  • Technical documentation
  • Regulatory documentation, where applicable

Why Choose Pizotifen API

Pizotifen is a well-characterized pharmaceutical active ingredient with an established role in migraine prophylaxis and serotonin-receptor pharmacology. Its CAS Number 15574-96-6, molecular formula C₁₉H₂₁NS, and molecular weight 295.4 g/mol provide clear identification of the free-base API.

The availability of analytical reference material with ≥98% HPLC assay provides a useful benchmark for analytical characterization, while the final pharmaceutical API quality requirements should always be established according to the applicable product specification and batch Certificate of Analysis.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
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