Talazoparib is a potent small-molecule inhibitor of poly(ADP-ribose) polymerase (PARP), an enzyme family involved in DNA damage repair. It is an orally active targeted anticancer pharmaceutical ingredient used in selected cancers associated with homologous recombination repair deficiencies, including certain BRCA-mutated cancers.
Talazoparib has the chemical formula C19H14F2N6O and a molecular weight of approximately 380.4 g/mol. Its CAS Number is 1207456-01-6. Talazoparib is also known by the development code BMN-673.
Talazoparib is a fluorinated tricyclic heterocyclic compound containing nitrogen-rich heterocyclic functionality. The stereochemically defined molecule is chemically identified as a PARP inhibitor.
CAS Number: 1207456-01-6
Molecular Formula: C19H14F2N6O
Molecular Weight: 380.4 g/mol
Development Code: BMN-673
Therapeutic Class: PARP Inhibitor
API Type: Small-Molecule Anticancer API
The active pharmaceutical ingredient should be distinguished from Talazoparib Tosylate, which has CAS Number 1373431-65-2 and a different molecular composition and molecular weight.
Talazoparib inhibits PARP enzymes involved in DNA damage response and repair. Inhibition of PARP catalytic activity interferes with the repair of single-strand DNA damage and promotes accumulation of DNA damage.
Talazoparib also produces PARP trapping, in which PARP proteins become associated with damaged DNA. This contributes to replication-associated DNA damage and can result in cancer-cell death, particularly in tumors with deficiencies in homologous recombination DNA repair pathways.
Talazoparib is an antineoplastic API associated with targeted treatment of cancers involving DNA-repair deficiencies.
Its clinical application includes selected patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Talazoparib is also used in certain patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer in combination with appropriate androgen-receptor pathway therapy.
The exact approved indication depends on the regulatory jurisdiction, biomarker status, treatment combination, and applicable product labeling.
Talazoparib is a potent small-molecule pharmaceutical ingredient and requires controlled analytical testing during API manufacture and release.
Typical quality evaluation may include:
Numerical acceptance criteria should be taken from the applicable approved, customer, or validated manufacturer specification for the exact Talazoparib form.
Swapnroop Drugs and Pharmaceuticals is an India-based pharmaceutical manufacturing organization serving pharmaceutical markets with quality-focused API manufacturing and analytical documentation.
Talazoparib is a specialized oncology API requiring controlled synthesis, impurity profiling, stereochemical control, analytical characterization, and appropriate pharmaceutical documentation. The exact API form, specification, packaging configuration, and regulatory requirements should be established according to the intended pharmaceutical application and market.
Talazoparib API should be packed in suitable pharmaceutical-grade containers that protect the material from moisture, contamination, and environmental exposure.
Storage conditions should follow the validated product specification and stability data applicable to the supplied API. Packaging configuration, retest period, and transportation conditions should be confirmed through the applicable quality documentation.
Documentation for Talazoparib API may include:
Talazoparib is a targeted anticancer API belonging to the PARP inhibitor class. With its molecular formula C19H14F2N6O and molecular weight of approximately 380.4 g/mol, it is a structurally complex small molecule designed to interfere with DNA damage repair pathways.
For pharmaceutical development and manufacturing, accurate control of identity, assay, related substances, stereochemical purity, residual solvents, elemental impurities, and stability is important. Swapnroop Drugs and Pharmaceuticals supports pharmaceutical customers with quality-focused API manufacturing and documentation for qualified pharmaceutical applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |