Roxatidine Impurity 55 CAS 100841-00-7
| CAS No. | 100841-00-7 |
| Molecular Formula | C10H15NO2 |
| Molecular Weight | 181.23 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Roxatidine Impurity 55 (CAS 100841-00-7, C10H15NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C10H15NO2, Roxatidine Impurity 55 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 181.23 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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.
As a certified reference material (CRM), Roxatidine Impurity 55 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.
Physical & Chemical Properties
| Molecular Formula | C10H15NO2 |
| Molecular Weight | 181.23 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >80% |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1985 |
| Nitrogen Atoms | 1 |
Related Roxatidine Standards
- Roxatidine Impurity 22 (CAS 72126-71-7)
- Roxatidine Impurity 49 (CAS 4530-44-3)
- Roxatidine Impurity 4 (CAS 73279-04-6)
- Roxatidine Impurity 45 (CAS 73152-41-7)
- Roxatidine Impurity 46 (CAS 4764-13-0)
- Roxatidine Impurity 71 (CAS CATO-C4X-121371)
- Roxatidine Impurity 80 (CAS 853574-98-8)
- Roxatidine Impurity 56 (CAS 132513-51-0)
Recommended Standards
- Tirofiban Impurity 38 (CAS 1558275-49-2)
- Tamsulosin EP Impurity F (CAS 6781-17-5)
- Mianserin Impurity 109 (CAS 4397-15-3)
- Omeprazole Impurity 60 (CAS 150054-47-0)
- Timolol EP Impurity C Maleate (CAS 610271-57-3)
- Piribedil Impurity 6 (CAS 4971-68-0)
- Afatinib Impurity 59 (CAS CATO-C4X-100659)
- 1-(5-Chloro-2-fluorophenyl)-1h-pyrazole-3-carboxylic acid (CAS 1155049-47-0)
- Decahydronaphthalene-2-carboxylic Acid (CAS 13032-41-2)
- 2-(Sec-butyl)-4-chloro-6-ethylthieno[2,3-d]pyrimidine (CAS 1340221-66-0)
- 1,2,3,4-Tetrahydro-1,5-naphthyridine (CAS 13993-61-8)
- 2-((Tert-butoxycarbonyl)amino)-3-(3-chloro-2-fluorophenyl)propanoic acid (CAS 1260010-17-0)
- 5-Pyrimidinecarboxylic acid, 2-[9-(2-propyn-1-yl)-3,9-diazaspiro[5.5]undec-3-yl]-, hydrochloride (1:1) (CAS 2363174-61-0)
- Insulin Degludec Impurity 10 (CAS CATO-C4X-215710)
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