Tirabrutinib Hydrochloride is a selective, orally active Bruton’s tyrosine kinase (BTK) inhibitor and a specialized oncology active pharmaceutical ingredient. It is the hydrochloride salt of Tirabrutinib, also known by the development codes ONO-4059 and GS-4059.
Tirabrutinib Hydrochloride has the CAS Number 1439901-97-9, molecular formula C₂₅H₂₂N₆O₃·HCl, and molecular weight 490.94 g/mol. The Japanese PMDA quality documentation describes the drug substance as a white to pale yellow or pale brown powder.
Tirabrutinib Hydrochloride is a small-molecule targeted oncology API belonging to the BTK inhibitor class. It is designed to bind covalently to Bruton’s tyrosine kinase, an important signaling protein involved in B-cell receptor signaling.
Tirabrutinib Hydrochloride has been developed for pharmaceutical applications involving B-cell malignancies and other diseases in which BTK signaling is therapeutically relevant. The compound received its initial approval in Japan in 2020 under the brand name Velexbru.
Product Name: Tirabrutinib Hydrochloride
Common Name: Tirabrutinib
CAS Number: 1439901-97-9
Free Base CAS Number: 1351636-18-4
Molecular Formula: C₂₅H₂₂N₆O₃·HCl
Expanded Formula: C₂₅H₂₃ClN₆O₃
Molecular Weight: 490.94 g/mol
Chemical Class: Purinone derivative
Therapeutic Class: Antineoplastic agent
Pharmacological Class: BTK inhibitor
Development Codes: ONO-4059, GS-4059
Appearance: White to pale yellow or pale brown powder
The free-base Tirabrutinib has the formula C₂₅H₂₂N₆O₃ and molecular weight 454.5 g/mol, while the hydrochloride API has a molecular weight of 490.94 g/mol.
Tirabrutinib Hydrochloride is a Bruton’s tyrosine kinase inhibitor. It covalently binds to BTK and inhibits BTK-mediated signaling.
BTK is an important component of B-cell receptor signaling and contributes to B-cell development, activation, proliferation and survival. By inhibiting this pathway, Tirabrutinib can interfere with signaling pathways associated with malignant B-cell proliferation.
Tirabrutinib Hydrochloride is an oncology-focused API used in pharmaceutical formulations for targeted treatment involving B-cell malignancies.
Its approved pharmaceutical applications vary by jurisdiction. In Japan, Tirabrutinib Hydrochloride has been approved for specific hematological oncology indications, including certain B-cell malignancies and primary central nervous system lymphoma.
The API is therefore relevant to the development and manufacture of specialized oral oncology formulations.
Tirabrutinib Hydrochloride is a chemically defined small-molecule API requiring comprehensive analytical controls.
Typical quality-control parameters include:
The PMDA regulatory-quality documentation identifies multiple potential specified impurities in the drug substance and demonstrates that impurity control is an important part of Tirabrutinib Hydrochloride API quality management.
Swapnroop Drugs and Pharmaceuticals provides quality-focused pharmaceutical API manufacturing and technical documentation solutions for specialized active pharmaceutical ingredients.
Tirabrutinib Hydrochloride is a specialized oncology API requiring controlled identity, assay, purity and impurity testing. A specification-driven analytical approach supports consistent quality and suitability for pharmaceutical development and manufacturing.
Swapnroop provides Tirabrutinib Hydrochloride API with quality-focused analytical testing and pharmaceutical documentation for qualified pharmaceutical requirements.
Tirabrutinib Hydrochloride should be packaged in suitable pharmaceutical-grade containers that protect the API from contamination, moisture and inappropriate environmental exposure.
PMDA quality documentation reports long-term stability studies at 30°C/65% RH using double low-density polyethylene bags and fiber drums, with no clear quality change reported during the evaluated period. Accelerated stability testing was conducted at 40°C/75% RH for 6 months.
For commercial API storage, the approved product specification, validated stability data and batch-specific Certificate of Analysis should be followed.
Technical documentation for Tirabrutinib Hydrochloride API may include:
Tirabrutinib Hydrochloride is a specialized targeted-oncology API requiring appropriate control of chemical identity, purity, related substances and stability.
Swapnroop focuses on specification-driven pharmaceutical API quality, analytical testing and technical documentation.
Tirabrutinib Hydrochloride API from Swapnroop is positioned for pharmaceutical customers seeking a quality-focused source of this specialized BTK inhibitor for pharmaceutical development and manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |