Complaint
| Items | Standards | Results |
| Appearance | White or off-white crystalline powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | slightly soluble in ethanol, very slightly soluble in water | Complies |
| Loss on Drying | ≤ 1.00% | 0.35% |
| Heavy Metals | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.06% |
| Related Substance | Any single impurity: ≤0.10% | 0.06% |
| Total Impurities: ≤1.00% | 0.18% | |
| Assay (HPLC basis on drying) | 98.0%~102.0% | 99.96% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
Olaparib as a maintenance therapy or monotherapy for the treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. On January 12, 2018, FDA expanded the approved use of Olaparib to include chemotherapy-experienced patients with germline breast cancer susceptibility gene (BRCA) mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.
