Niraparib Tosylate is a pivotal active pharmaceutical ingredient and certified reference standard for quality control of this PARP inhibitor. In quality control contexts, Niraparib Tosylate and its related impurities are essential analytical reference standards for impurity profiling and analytical method development. As the tosylate monohydrate salt, Niraparib Tosylate offers enhanced aqueous solubility and improved crystallinity. The PARP inhibitory mechanism of Niraparib Tosylate exploits synthetic lethality in tumors with homologous recombination repair deficiencies, making this compound therapeutically important for ovarian and other cancers .
|
Parameter |
Specification |
|
Product Name |
Niraparib Tosylate |
|
CAS Number |
1613220-15-7 |
|
Molecular Formula |
C₁₉H₂₀N₄O · C₇H₈O₃S · H₂O |
|
Molecular Weight |
510.61 g/mol |
|
Appearance |
Solid |
|
Storage Condition |
Protected from light, 10–30°C |
Niraparib tosylate monohydrate is the tosylate salt and hydrate form of niraparib, and also a selective inhibitor of PARP1/2 (IC50 = 3.8 nM and 2.1 nM), which has been approved by the FDA for the treatment of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
Journal of Medicinal Chemistry, 2009, Vol. 52, No. 22 reported the synthetic route: In the process of synthesizing Niraparib, platinum oxide was used for the reduction of the pyridine ring, and this reagent has a relatively high cost. Sodium azide was used for the synthesis of the pyrazole ring, and this step is relatively dangerous in scale-up preparation, so this reagent should be avoided. After the racemic Niraparib is finally synthesized by this route, chiral resolution is carried out using a supercritical chiral separation column. This process has a high cost and is not conducive to scale-up preparation.
Cosperpharm has established a comprehensive quality assurance system for Niraparib Tosylate:
Thorough analytical characterization. Each batch undergoes multi-technique analytical release testing: HPLC purity verification, water content determination, residual solvent analysis, and where applicable, ¹H NMR and MS confirmation of molecular identity.
Full batch traceability with retention samples. From raw material procurement through synthesis, purification, and final packaging, every step is fully documented and traceable.
Stability monitoring program. Cosperpharm conducts ongoing stability studies under recommended storage conditions.
Documentation ready for regulatory submission. Every shipment includes a Certificate of Analysis (COA), Safety Data Sheet (SDS), and customs documentation. DMF-ready documentation packages are available upon request.
Customer-initiated quality audits. Qualified customers are welcome to audit Cosperpharm's manufacturing, quality control, and documentation facilities.
Looking for Niraparib Tosylate for your PARP inhibitor development program or analytical method validation? Cosperpharm provides reliable supply and technical support—get in touch to discuss your needs.
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