Gemcitabine Impurity N2 CAS 928797-50-6
| CAS No. | 928797-50-6 |
| Molecular Formula | C10H16F2O5 |
| Molecular Weight | 254.23 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Gemcitabine Impurity N2 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.
Gemcitabine Impurity N2 (CAS 928797-50-6) is a certified pharmaceutical impurity reference standard with the molecular formula C10H16F2O5 and a molecular weight of 254.23 g/mol.
Structurally, Gemcitabine Impurity N2 (C10H16F2O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 254.23 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 | C10H16F2O5 |
| Molecular Weight | 254.23 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F-containing |
Related Gemcitabine Standards
- Gemcitabine Impurity 17 (CAS 95058-92-7)
- Gemcitabine Impurity 36 (CAS 166376-97-2)
- Gemcitabine Impurity 23 (CAS 82188-74-7)
- Gemcitabine Impurity N1 (CAS 103882-85-5)
- Gemcitabine (CAS 95058-81-4)
- Gemcitabine EP Impurity B (CAS 95058-85-8)
- Gemcitabine Impurity 14 (CAS 294177-31-4)
- Gemcitabine Impurity 20 (CAS 153381-14-7)
Recommended Standards
- Ethyl 2-(difluoromethyl)-8-methylimidazo[1,2-a]pyridine-3-carboxylate (CAS 2514942-05-1)
- N-(3-Amino-5-(trifluoromethyl)phenyl)methanesulfonamide (CAS 873056-09-8)
- Ethyl 2-(difluoromethyl)-6-methylimidazo[1,2-a]pyridine-3-carboxylate (CAS 2514953-09-2)
- N,2-Dimethyl-6-(trifluoromethyl)pyridine-3-sulfonamide (CAS 2108822-19-9)
- Oxacillin EP Impurity G (CAS 724695-30-1)
- Fluticasone Impurity 49 (CAS CATO-C4X-165049)
- N-Nitroso Revefenacin impurity 99 (CAS CATO-C4X-203199)
- 3-Acetyl-5-chloroindole (CAS 51843-24-4)
- N-(4-Cyanophenyl)-2-(4-(2,6-dioxo-1,3-dipropyl-2,3,6,9-tetrahydro-1H-purin-8-yl)phenoxy)acetamide (CAS 264622-58-4)
- (2S)-2-({2-azabicyclo[2.2.1]heptan-2-yl}carbonylamino)propanoic acid (CAS 1485623-74-2)
- (4-Methylpyrrolidin-2-yl)methanol (CAS 1248567-73-8)
- 1-(2,5-Dichlorophenyl)-1H-pyrrole-2-carbaldehyde (CAS 881041-52-7)
- 2-Amino-5-phenylpyrimidine-4,6-diol (CAS 154146-07-3)
- Tirzepatide Impurity 45 (CAS CATO-C4X-324045)
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