| CAS No. | 545348-09-2 |
| Molecular Formula | C9H16N2O |
| Molecular Weight | 168.24 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Olaparib Impurity 104.
As a process- or degradation-related impurity, Olaparib Impurity 104 (CAS 545348-09-2, C9H16N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Olaparib Impurity 104 (C9H16N2O) is characterized by an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a certified reference material (CRM), Olaparib Impurity 104 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C9H16N2O |
| Molecular Weight | 168.24 g/mol |
| Appearance | White to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1984 |
| Nitrogen Atoms | 2 |