Olaparib

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Diamide Impurity of Olaparib

  • CAT Number DCTI-C-2092
  • CAS Number 2250242-62-5
  • Molecular Formula C36H28F2N6O4
  • Molecular Weight 646.65

Diketo Impurity of Olaparib

  • CAT Number DCTI-C-2091
  • CAS Number NA
  • Molecular Formula C42H36F2N8O6
  • Molecular Weight 786.8

Olaparib Acid Impurity

  • CAT Number DCTI-C-2090
  • CAS Number 763114-26-7
  • Molecular Formula C16H11FN2O3
  • Molecular Weight 298.27

Olaparib Amine impurity

  • CAT Number DCTI-C-2110
  • CAS Number 763111-47-3
  • Molecular Formula C20H19FN4O2
  • Molecular Weight 366.4

Olaparib Desfluoro Impurity

  • CAT Number DCTI-C-1865
  • CAS Number 763113-06-0
  • Molecular Formula C24H24N4O3
  • Molecular Weight 416.48

Olaparib Dimethylbenzamide Impurity

  • CAT Number DCTI-C-1619
  • CAS Number 2415448-60-9
  • Molecular Formula C18H16FN3O2
  • Molecular Weight 325.34

Olaparib Impurity E

  • CAT NUMBER DCTI-C-3219
  • CAS NUMBER 1830366-25-0
  • MOLECULAR FORMULA C24H21FN2O4
  • MOLECULAR WEIGHT 420.44

Olaparib N-Boc Impurity

  • CAT Number DCTI-C-2093
  • CAS Number 763114-04-1
  • Molecular Formula C25H27FN4O4
  • Molecular Weight 466.51

Olaparib Pyrolidione Adduct

  • CAT Number DCTI-C-2111
  • CAS Number NA
  • Molecular Formula C28H28FN5O4
  • Molecular Weight 517.56

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 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.

References
FAQ's

Frequently Asked Questions

It's difficult to remove all impurities from any pharmaceutical product, including Olaparib. Manufacturers work hard to reduce impurities through optimized synthesis procedures, purification techniques, and quality control. The goal is to maintain impurity levels considerably below the permissible limits set by regulatory bodies to assure the drug's safety and efficacy.

Impurities might occur as unexpected byproducts or side reactions during the production of Olaparib. They can emerge as a result of incomplete reaction conditions, chemical transformations, or the usage of impure starting materials.

Impurities in Olaparib may impair its efficacy, safety, and overall quality. They must be regulated and monitored to ensure purity and the drug's efficacy.

Olaparib Impurities should be stored at a regulated room temperature of 2-8°C or as specified on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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