Tapentadol Impurity 1 CAS 2645-08-1
| CAS No. | 2645-08-1 |
| Molecular Formula | C15H22N4O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Tapentadol Impurity 1 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.
Tapentadol Impurity 1 (CAS 2645-08-1) is a certified pharmaceutical impurity reference standard with the molecular formula C15H22N4O3HCl and a molecular weight of 342.82 g/mol.
Structurally, Tapentadol Impurity 1 (C15H22N4O3HCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 342.82 g/mol, it falls into the moderately-high-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 | C15H22N4O3 HCl |
| Molecular Weight | 342.82 g/mol |
| Appearance | Off-white to pale 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 DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |
Related Tapentadol Standards
- Tapentadol-d5 Hydrochloride (CAS 1217724-63-4)
- Tapentadol O-beta-D-Glucuronide (CAS 1300037-86-8)
- Tapentadol O-Sulfate (CAS 1300037-87-9)
- Tapentadol-d5 O-Sulfate (CAS 1346598-84-2)
- Tapentadol N-Oxide (CAS 1346601-17-9)
- Tapentadol-d5 N-Oxide (CAS 1346603-32-4)
- Tapentadol N-Oxide (CAS 1422277-62-0)
- Tapentadol-D3 HCl (CAS 1435782-38-9)
Recommended Standards
- Resmetirom impurity 95 (CAS CATO-C4X-291295)
- Elagolix Impurity 68 (CAS CATO-C4X-206868)
- LCZ-696 Impurity 43 (CAS 2216755-67-6)
- 2-((3-Isopropylisoxazol-5-yl)methoxy)ethan-1-amine (CAS 1431964-02-1)
- Allene (CAS 463-49-0)
- (3-Aminopropanoyl)-L-methionine (CAS 17136-27-5)
- Methyl 5-bromo-3-(2,2,2-trifluoroacetamido)thiophene-2-carboxylate (CAS 852330-31-5)
- 1,6-Diiodonaphthalene (CAS 64567-12-0)
- 3-Amino-4,4,4-trifluorobutan-1-ol (CAS 914223-46-4)
- Allo-Thr5-Tirzepatide (CAS CATO-CPTD788934)
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