General Information

Olaparib Impurities and Olaparib  

Daicel Pharma offers Olaparib impurities that include Olaparib Acid Impurity, Olaparib N-Boc Impurity, Olaparib Amine impurity, Olaparib Pyrolidione Adduct, Olaparib Desfluoro Impurity, Olaparib Dimethylbenzamide Impurity, Diketo Impurity of Olaparib, and Diamide Impurity of Olaparib. These impurities are critical for determining  Olaparib quality, stability, and safety. Daicel Pharma custom synthesizes and distributes Olaparib impurities worldwide.

Olaparib [CAS: 763113-22-0], an antineoplastic drug treating advanced ovarian cancer, belongs to the N-acylpiperazine family. Olaparib treats patients with germline BRCA1/2-mutations who have HER2-negative locally advanced or metastatic breast cancer.

Olaparib: Use and Commercial Availability  

Olaparib treats adults diagnosed with advanced BRCA1/2-mutated high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have shown a complete or partial response to first-line platinum-based chemotherapy. Furthermore, Olaparib is for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. It is available as Lynparza.

Olaparib Structure and Mechanism of Action

The chemical name of Olaparib is 4-[[3-[[4-(Cyclopropylcarbonyl)-1-piperazinyl]carbonyl]-4-fluorophenyl]methyl]-1(2H)-phthalazinone. Its chemical formula is C₂₄H₂₃FN₄O₃, and its molecular weight is approximately 434.5 g/mol.

Olaparib inhibits poly (ADP-ribose) polymerase (PARP) enzymes, PARP1, PARP2, and PARP3. It prevents PARP enzyme activity leading to tumor cell death.

Olaparib Impurities and Synthesis

Olaparib impurities are unwanted chemicals that may be present in the medication formulation. They can come from sources, including starting materials, reagents, intermediates, and byproducts during the synthetic process¹. Impurities must be under control and monitored to assure the quality and safety of Olaparib.

Daicel provides a Certificate of Analysis (CoA) of Olaparib impurity standards such as Olaparib Acid Impurity, Olaparib N-Boc Impurity, Olaparib Amine impurity, Olaparib Pyrolidione Adduct, Olaparib Desfluoro Impurity, Olaparib Dimethylbenzamide Impurity, Diketo Impurity of Olaparib, and Diamide Impurity of Olaparib. Daicel Pharma has a cGMP-compliant analytical laboratory that offers the CoA, which contains extensive characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We give additional characterization data, such as 13C-DEPT, on request.