Tipiracil HCl API Manufacturer in India
Swapnroop Drugs & Pharmaceuticals offers Tipiracil HCl (Tipiracil Hydrochloride) as a pharmaceutical active ingredient for oncology drug development and pharmaceutical manufacturing applications. Tipiracil hydrochloride is a thymidine phosphorylase inhibitor used in combination with trifluridine in approved anticancer treatments.
About Tipiracil HCl API
Tipiracil hydrochloride is the hydrochloride salt of Tipiracil. It is a pyrimidine derivative and small-molecule antineoplastic API. Tipiracil inhibits thymidine phosphorylase, helping prevent the degradation of trifluridine when the two active ingredients are used together.
Chemical and Pharmaceutical Profile
Product Name: Tipiracil HCl
CAS No.: 183204-72-0
Molecular Formula: C9H11ClN4O2·HCl
Molecular Weight: 279.12 g/mol
Chemical Class: Pyrimidine derivative
Pharmacological Class: Thymidine phosphorylase inhibitor
Therapeutic Category: Antineoplastic
Appearance: White crystalline powder
Melting Point: 240°C with decomposition
pH: 3.74 at 10 mg/mL in water
pKa: 5.95
Pharmaceutical Applications
Tipiracil HCl is primarily used together with trifluridine in oncology pharmaceutical formulations. The combination is used for certain advanced or metastatic cancers according to approved regulatory indications.
Mechanism of Action
Tipiracil inhibits thymidine phosphorylase, an enzyme responsible for the degradation of trifluridine. By inhibiting this enzyme, Tipiracil increases the exposure and availability of trifluridine, supporting the anticancer activity of the combination.
Quality and Analytical Testing
Tipiracil HCl can be evaluated using pharmaceutical analytical techniques including HPLC, HPLC-related substance testing, IR identification, water determination, residue on ignition, heavy-metal testing and residual-solvent analysis.
Tipiracil HCl API Manufacturer in India
Swapnroop Drugs & Pharmaceuticals provides Tipiracil HCl for pharmaceutical manufacturing and development requirements with quality-focused manufacturing, analytical testing and batch-specific documentation.
Packaging and Storage
Tipiracil HCl should be packed in suitable, tightly closed pharmaceutical-grade containers and protected from moisture. Storage should be maintained according to the approved product specification and stability requirements.
Documentation
Certificate of Analysis (CoA), Product Specification, Certificate of Conformance (CoC), Safety Data Sheet (SDS), analytical reports, batch information, stability documentation and applicable regulatory documents can be provided according to customer requirements.
Why Choose Swapnroop
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| pH (1% Solution) | 3.74 |
| Melting Point | Approximately 240–245°C with decomposition |