Pranlukast Hydrate API is a pharmaceutical-grade cysteinyl leukotriene receptor antagonist used in respiratory and allergic disease management. The official Japanese Pharmacopoeia identifies Pranlukast Hydrate as N-[4-Oxo-2-(1H-tetrazol-5-yl)-4H-chromen-8-yl]-4-(4-phenylbutyloxy)benzamide hemihydrate, with the molecular formula C27H23N5O4·½H2O, molecular weight 490.51 g/mol, and CAS Number 150821-03-7.
Pranlukast Hydrate occurs as a white to light yellow crystalline powder. According to the Japanese Pharmacopoeia, it is very slightly soluble in ethanol (99.5) and practically insoluble in water. Its melting point is approximately 233°C with decomposition.
Pranlukast Hydrate is the hydrated pharmaceutical form of Pranlukast. The anhydrous Pranlukast active moiety has CAS 103177-37-3 and molecular weight 481.50 g/mol, while the pharmacopoeial hydrate has CAS 150821-03-7 and molecular weight 490.51 g/mol.
| Parameter | Value |
|---|---|
| Product Name | Pranlukast Hydrate |
| CAS Number | 150821-03-7 |
| Alternate / Anhydrous CAS | 103177-37-3 |
| Molecular Formula | C27H23N5O4·½H2O |
| Molecular Weight | 490.51 g/mol |
| Anhydrous Molecular Weight | 481.50 g/mol |
| UNII | FR702N558K |
| Development Code | ONO-1078 / ONO-RS-411 |
| Drug Class | Cysteinyl leukotriene receptor antagonist |
| Physical Form | Crystalline powder |
| Appearance | White to light yellow crystalline powder |
| Pharmacopoeial Standard | Japanese Pharmacopoeia (JP) |
The FDA GSRS record also identifies the substance as Pranlukast Hemihydrate and maps CAS 150821-03-7 to the hydrate form.
Pranlukast Hydrate is a chromone-derived leukotriene receptor antagonist. Its chemical structure incorporates a tetrazole group, chromone ring and phenylbutoxybenzamide moiety.
The Japanese Pharmacopoeia specifies the chemical name as N-[4-Oxo-2-(1H-tetrazol-5-yl)-4H-chromen-8-yl]-4-(4-phenylbutyloxy)benzamide hemihydrate.
Pranlukast acts by antagonizing cysteinyl leukotriene receptors and thereby reducing leukotriene-mediated bronchoconstriction and allergic inflammatory responses. It has been used as an antiasthmatic and antiallergic pharmaceutical ingredient.
The hydrate state is an important quality attribute because the pharmacopoeial material is specifically defined as a hemihydrate. The JP therefore controls water content at 1.5–2.2%.
Pranlukast Hydrate is a CysLT1 receptor antagonist used in pharmaceutical preparations for respiratory allergic conditions, particularly bronchial asthma and allergic rhinitis.
By blocking the action of cysteinyl leukotrienes, Pranlukast can reduce leukotriene-mediated airway constriction and inflammatory responses. Drug databases classify Pranlukast as a cysteinyl leukotriene receptor-1 antagonist and identify its antiasthmatic and antiallergic applications.
Pranlukast Hydrate has a defined Japanese Pharmacopoeia monograph, making it possible to use verified numerical specifications for several of your CMS fields.
The JP monograph includes:
The official JP assay requires 98.0–101.0% Pranlukast, calculated on the anhydrous basis. Water is controlled at 1.5–2.2%, residue on ignition at NMT 0.2%, heavy metals at NMT 20 ppm, and arsenic at NMT 2 ppm.
For related substances, the JP chromatographic procedure compares impurity peak areas against a diluted Pranlukast reference solution. The official procedure corresponds to approximately NMT 0.50% for the specified impurity at relative retention time around 1.5, NMT 0.20% for other individual impurities, and approximately NMT 1.0% total related substances.
Pranlukast Hydrate manufacturing requires controlled synthesis, purification and careful management of the hydrate state. Because the pharmacopoeial API is specifically the hemihydrate, water content is an important quality attribute.
A suitable analytical control strategy includes HPLC assay, related-substance testing, UV/IR identification, water determination, residue on ignition, heavy-metal testing and arsenic determination.
The Japanese Pharmacopoeia provides an established analytical framework for controlling Pranlukast Hydrate quality.
Pranlukast Hydrate should be packaged in tight containers to protect the material from environmental exposure and contamination. The JP specifies tight containers for the substance.
Because Pranlukast is supplied as a hemihydrate, excessive exposure to moisture or drying conditions should be avoided because changes in hydration state can affect the material's analytical characteristics.
Commercial research material is also commonly stored under controlled low-temperature conditions. Sigma-Aldrich identifies Pranlukast hemihydrate as a solid and reports it as practically insoluble in water.
Pranlukast Hydrate API documentation may include:
Pranlukast Hydrate is a well-characterized pharmaceutical ingredient with an established Japanese Pharmacopoeia monograph. Unlike APIs where only commercial research specifications are available, the JP provides verified numerical requirements for assay, water, residue on ignition, heavy metals, arsenic and related substances.
For API quality documentation, the exact hydrate form should be maintained as Pranlukast Hydrate, CAS 150821-03-7, rather than using the specifications of anhydrous Pranlukast.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0–101.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.50% |
| Total Impurities | NMT 1.0% |
| Melting Point | 1.5–2.2% |