Naloxone EP Impurity A HCl(Naltrexone EP Impurity B HCl) CAS 33522-95-1
| CAS No. | 33522-95-1 |
| Molecular Formula | C16H17NO4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 323.77 g/mol gives Naloxone EP Impurity A HCl(Naltrexone EP Impurity B HCl) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Naloxone EP Impurity A HCl(Naltrexone EP Impurity B HCl) (CAS 33522-95-1, C16H17NO4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Naloxone EP Impurity A HCl(Naltrexone EP Impurity B HCl) (C16H17NO4HCl) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
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.
Physical & Chemical Properties
| Molecular Formula | C16H17NO4 HCl |
| Molecular Weight | 323.77 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1966 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Naloxone Standards
- Naloxone Impurity 21 (CAS 119630-94-3)
- Naloxone-D5 (CAS 1261079-38-2)
- Naloxone-d5 3-Methyl Ether (1.0mg/ml in Acetonitrile) (CAS 1261082-21-6)
- Naloxone Hydrochloride EP Impurity B (CAS 1352085-46-1)
- Naloxone-d5 HCl (CAS 1426174-78-8)
- Naloxone Impurity 18 (CAS 156047-22-2)
- Naloxone Hydrochloride EP Impurity E (CAS 211738-08-8)
- Naloxone Hydrochloride EP Impurity C (CAS 2139253-68-0)
Recommended Standards
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- 2-(2,3-Dihydrobenzo[b][1,4]dioxin-5-yl)-4,4,5,5-tetramethyl-1,3,2-dioxaborolane (CAS 1116104-19-8)
- 1-(2-Bromoethyl)-3-nitro-1h-pyrazole (CAS 885689-61-2)
- 9-(Diphenylmethylene)-9H-fluorene (CAS 4709-68-6)
- 3-(Dimethylsulfamoyl)benzene-1-sulfonyl chloride (CAS 197891-83-1)
- N-5-phenyl-1H-tetrazole-1,5-diamine (CAS 5533-44-8)
- Semaglutide impurity 30 (CAS CATO-C4X-222630)
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