| CAS No. | 75281-25-3 |
| Molecular Formula | C20H28O3 |
| Molecular Weight | 316.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 316.43 g/mol gives Isotretinoin EP Impurity I distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Isotretinoin EP Impurity I (CAS 75281-25-3) is a certified pharmaceutical impurity reference standard with the molecular formula C20H28O3 and a molecular weight of 316.43 g/mol.
The molecular framework of Isotretinoin EP Impurity I (C20H28O3) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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), Isotretinoin EP Impurity I 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 | C20H28O3 |
| Molecular Weight | 316.43 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >90% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1978 |