Phenylephrine Hydrochloride EP Impurity A HCl (R-Isomer) CAS 636-87-3
| CAS No. | 636-87-3 |
| Molecular Formula | C8H11NO2 |
| Molecular Weight | N/A |
| 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.
As a process- or degradation-related impurity, Phenylephrine Hydrochloride EP Impurity A HCl (R-Isomer) (CAS 636-87-3, C8H11NO2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Phenylephrine Hydrochloride EP Impurity A HCl (R-Isomer) (C8H11NO2HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 189.64 g/mol, it falls into the medium-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C8H11NO2 HCl |
| Molecular Weight | 189.64 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Phenylephrine Standards
- Phenylephrine Impurity 58 (CAS 1007885-60-0)
- Phenylephrine Impurity 100 (CAS 1026633-55-5)
- Phenylephrine Related Compound G (CAS 1094089-46-9)
- Phenylephrine EP Impurity D Racemate (CAS 1159977-09-9)
- Phenylephrine Impurity 18 (Mixture of Diastereomers) (CAS 1217525-08-0)
- Phenylephrine-d3 HCl (Methyl-d3) (CAS 1217858-50-8)
- Phenylephrine-3-O-Sulfate (CAS 1242184-39-9)
- Phenylephrine 2-O-β-glucuronide, >98% (CAS 1260611-56-0)
Recommended Standards
- Bendamustine Impurity 4 (CAS 3543-73-5)
- Lecithin Impurity 5 (CAS 1934266-33-7)
- Obeticholic Acid Impurity 5 (CAS 915038-26-5)
- 5-Bromo-1-phenyl-1H-pyrazole-4-carbonitrile (CAS 76767-44-7)
- 2-(2-Bromoallyl)isoindoline-1,3-dione (CAS 500589-29-7)
- 1-Bromo-2-(difluoromethyl)-3-fluorobenzene (CAS 1166820-46-7)
- Benzyldimethyloctylammonium Chloride (CAS 959-55-7)
- 2-(1H-benzo[d][1,2,3]triazol-1-yl)-2-(9H-carbazol-9-yl)-1-phenylethan-1-one (CAS 124337-48-0)
- 2-(Oxo-8-(pyridin-2-yl)pyrazolo[1,5-d][1,2,4]triazin-1-yl)acetic acid (CAS 1708428-15-2)
- Semaglutide Impurity 190 (CAS CATO-C4X-2226190)
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