Pizotifen Malate API is the pharmaceutical malate salt of pizotifen, a serotonin antagonist with antihistaminic and weak antimuscarinic properties. It is primarily associated with the prophylactic management of migraine and recurrent vascular headaches. Pizotifen Malate is identified by CAS Number 5189-11-7, molecular formula C₂₃H₂₇NO₅S, and molecular weight 429.5 g/mol. FDA's Global Substance Registration System identifies the substance as Pizotyline Malate/Pizotifen Malate, while PubChem confirms its chemical identity and molecular characteristics.
Pizotifen belongs to the benzocycloheptathiophene class of compounds and is generally formulated as the malate salt for pharmaceutical applications. The molecule has pharmacological activity at serotonin and histamine receptors and also exhibits weak antimuscarinic activity. Its established pharmaceutical use is primarily related to prevention rather than acute treatment of migraine attacks.
Pizotifen Malate is supplied as a crystalline pharmaceutical active ingredient. The compound is described as a malate salt formed from pizotifen and malic acid in a 1:1 ratio. The molecular formula is C₂₃H₂₇NO₅S, corresponding to the component representation C₁₉H₂₁NS · C₄H₆O₅. Its molecular weight is 429.5 g/mol.
The API is relevant to pharmaceutical manufacturing where controlled identity, assay, related substances, loss on drying and inorganic residue are important quality attributes. Commercial reference material is described as a crystalline solid, with analytical-grade material commonly offered at ≥98% purity; this value should be distinguished from a formal pharmacopoeial release specification.
Pizotifen Malate is chemically identified as Pizotifen Hydrogen Malate and is composed of pizotifen and malic acid in a 1:1 salt relationship. The API has CAS Number 5189-11-7 and UNII 99O99YVR4C.
Pizotifen itself has the molecular formula C₁₉H₂₁NS and molecular weight 295.4 g/mol, while the malate salt has a molecular weight of 429.5 g/mol.
Pizotifen Malate is primarily used in pharmaceutical formulations intended for migraine prophylaxis and prevention of recurrent vascular headaches. It is not generally used for the immediate relief of an established migraine attack.
Its pharmacological profile includes serotonin-antagonist, histamine-antagonist and weak antimuscarinic activity. These properties contribute to its use in preventive migraine therapy.
Quality control of Pizotifen Malate should include appropriate identification and purity testing. Important analytical parameters include:
For commercial pharmaceutical API, the final acceptance criteria should always correspond to the applicable approved specification, customer requirement or pharmacopoeial standard.
Pizotifen Malate is therefore suitable for quality-focused pharmaceutical API manufacturing with controlled analytical testing and batch-specific documentation.
As a Pizotifen Malate API Manufacturer in India, we focus on providing quality-controlled pharmaceutical API material for pharmaceutical development and manufacturing applications.
Pizotifen Malate can be supported with appropriate analytical documentation including Certificate of Analysis, product specifications, technical documentation and safety information according to applicable requirements.
Consistent control of raw materials, manufacturing processes, assay, related substances and physical characteristics is important for maintaining reliable API quality. Our manufacturing approach is designed to support pharmaceutical customers requiring dependable Pizotifen Malate API for formulation and production applications.
Pizotifen Malate should be packed in suitable pharmaceutical-grade, tightly closed containers that protect the material from contamination and environmental exposure.
The storage condition should follow the applicable approved specification and validated stability data. Packaging and handling should be performed under controlled conditions appropriate for pharmaceutical API materials.
Available documentation may include:
Pizotifen Malate is an established pharmaceutical active ingredient with a well-defined chemical identity and recognized application in migraine prophylaxis. Its defined CAS number, molecular formula and molecular weight make it readily identifiable for pharmaceutical development and manufacturing.
For companies seeking a Pizotifen Malate API Manufacturer in India, quality-focused production, analytical testing and appropriate batch documentation are essential for reliable pharmaceutical API sourcing and manufacturing support.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.5–101.5% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 0.10% |
| Water Content | NMT 0.5% |