Tipiracil Hydrochloride is a small-molecule antineoplastic active pharmaceutical ingredient belonging to the pyrimidinedione class. It is the hydrochloride salt of tipiracil and acts as an inhibitor of thymidine phosphorylase.
Tipiracil Hydrochloride has the CAS Number 183204-72-0, molecular formula C₉H₁₁ClN₄O₂·HCl, and molecular weight 279.12 g/mol. FDA describes it as a white crystalline powder that is soluble in water and certain dilute aqueous solutions.
Tipiracil Hydrochloride is an oncology-focused pharmaceutical API used in combination with trifluridine. The combination is designed to provide complementary pharmacological activity, with trifluridine acting as a nucleoside metabolic inhibitor and tipiracil inhibiting thymidine phosphorylase.
Tipiracil hydrochloride is the pharmaceutical salt form used in the approved trifluridine/tipiracil medicinal product. FDA identifies the two active ingredients in a molar ratio of 1:0.5.
Product Name: Tipiracil Hydrochloride
CAS Number: 183204-72-0
Free Base CAS Number: 183204-74-2
Molecular Formula: C₉H₁₁ClN₄O₂·HCl
Expanded Formula: C₉H₁₂Cl₂N₄O₂
Molecular Weight: 279.12 g/mol
Chemical Class: Pyrimidinedione derivative
Therapeutic Class: Antineoplastic agent
Pharmacological Class: Thymidine phosphorylase inhibitor
Development Code: TAS-1-462
Appearance: White crystalline powder
The free base tipiracil has the molecular formula C₉H₁₁ClN₄O₂ and molecular weight 242.66 g/mol, while the hydrochloride salt has a molecular weight of 279.12 g/mol.
Tipiracil Hydrochloride inhibits thymidine phosphorylase, an enzyme involved in the metabolism of nucleoside compounds. In the trifluridine/tipiracil combination, inhibition of thymidine phosphorylase reduces the degradation of trifluridine and increases its systemic exposure.
This pharmacological relationship allows tipiracil to support the activity of trifluridine in the combination medicinal product.
Tipiracil Hydrochloride is primarily used as an oncology pharmaceutical API in combination with trifluridine.
The approved trifluridine/tipiracil product is used for specified advanced or metastatic solid-tumor indications, including colorectal cancer and certain gastric or gastroesophageal junction cancers, according to applicable regulatory labeling.
The API is therefore relevant to pharmaceutical development and manufacturing of oral antineoplastic formulations.
Tipiracil Hydrochloride requires appropriate quality controls for a pharmaceutical small molecule. Typical analytical controls include:
Because universal pharmacopoeial numerical acceptance limits were not established in the FDA sources reviewed for every CMS specification field, release criteria should be based on the applicable registered specification and validated analytical methods rather than unsupported generic values.
Swapnroop Drugs and Pharmaceuticals provides quality-focused pharmaceutical API manufacturing and documentation solutions for specialized oncology APIs.
Tipiracil Hydrochloride requires controlled analytical testing because the API is used as an active component of an antineoplastic combination. Appropriate controls for identity, assay, related substances, residual solvents and other quality attributes help support consistent pharmaceutical quality.
Swapnroop provides Tipiracil Hydrochloride API with specification-focused analytical testing and pharmaceutical documentation for qualified pharmaceutical requirements.
Tipiracil Hydrochloride should be packaged in suitable pharmaceutical-grade, well-closed containers that protect the API from contamination, moisture and inappropriate environmental exposure.
Storage conditions should follow the approved product specification, stability data and batch-specific Certificate of Analysis.
Technical documentation for Tipiracil Hydrochloride API may include:
Tipiracil Hydrochloride is a specialized oncology API requiring appropriate control of identity, purity and analytical quality. Swapnroop focuses on specification-driven pharmaceutical API quality, analytical testing and technical documentation.
Tipiracil Hydrochloride API from Swapnroop is positioned for pharmaceutical customers seeking a quality-focused source of this specialized thymidine phosphorylase 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% |