Naloxone Hydrochloride EP Impurity E CAS 211738-08-8
| CAS No. | 211738-08-8 |
| Molecular Formula | C38H40N2O8 |
| Molecular Weight | 652.73 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
CATO supplies Naloxone Hydrochloride EP Impurity E (CAS 211738-08-8), a pharmacopoeial impurity reference standard (molecular formula C38H40N2O8, MW 652.73 g/mol) used for the identification and quantification of trace impurities in APIs.
Naloxone Hydrochloride EP Impurity E (C38H40N2O8) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).
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 | C38H40N2O8 |
| Molecular Weight | 652.73 g/mol |
| Purity | >90% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 20.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2017 |
| Nitrogen Atoms | 2 |
Related Naloxone Standards
- Naloxone impurity 14 (CAS CATO-C4X-149314)
- Naloxone 3-beta-D-Glucuronide (CAS 22135-79-1)
- Naloxone Impurity 21 (CAS 119630-94-3)
- Naloxone Impurity 20 (CAS 50510-01-5)
- Naloxone-d5 HCl (CAS 1426174-78-8)
- Naloxone Hydrochloride EP Impurity B (CAS 1352085-46-1)
- Naloxone Impurity 10 (CAS CATO-C4X-149310)
- Naloxone Impurity 11 (CAS CATO-C4X-149311)
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- (4-Fluoro-6-methoxypyridin-3-yl)boronic acid (CAS 2225180-40-3)
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Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com