Phenylephrine EP Impurity D CAS 1367567-95-0
| CAS No. | 1367567-95-0 |
| Molecular Formula | C16H19NO2 |
| Molecular Weight | 257.33 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Phenylephrine EP Impurity D (CAS 1367567-95-0) is a certified pharmaceutical impurity reference standard with the molecular formula C16H19NO2 and a molecular weight of 257.33 g/mol.
Structurally, Phenylephrine EP Impurity D (C16H19NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 257.33 g/mol, it falls into the medium-molecular-weight range. 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).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
Physical & Chemical Properties
| Molecular Formula | C16H19NO2 |
| Molecular Weight | 257.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Nitrogen Atoms | 1 |
Related Phenylephrine Standards
- Phenylephrine EP Impurity D Racemate (CAS 1159977-09-9)
- Phenylephrine Impurity 30 (CAS 286426-31-1)
- Phenylephrine EP Impurity E (CAS 56917-44-3)
- Phenylephrine Impurity 23 (CAS CATO-C4X-146723)
- Phenylephrine Impurity 84 (CAS CATO-C4X-146784)
- Phenylephrine Impurity 85 (CAS CATO-C4X-146785)
- Phenylephrine Impurity 62(Phenylephrine Isoquinolinone Analog) (CAS CATO-C4X-146762)
- Phenylephrine Impurity 25 (CAS CATO-C4X-146725)
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