Isosorbide Dinitrate Impurity 12 CAS 1217604-00-6
| CAS No. | 1217604-00-6 |
| Molecular Formula | [13C]6H9NO6 |
| Molecular Weight | 197.09 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Isosorbide Dinitrate Impurity 12 is closely related to an organic framework in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Isosorbide Dinitrate Impurity 12 (CAS 1217604-00-6, [13C]6H9NO6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Isosorbide Dinitrate Impurity 12 ([13C]6H9NO6) is characterized by an organic framework. 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 | [13C]6H9NO6 |
| Molecular Weight | 197.09 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | -2.0 |
| CAS Registry Year (est.) | 1990 |
| Nitrogen Atoms | 1 |
Related Isosorbide Standards
- Isosorbide-13C6 DiNitrate (CAS 1391051-97-0)
- Isosorbide Dinitrate, Diluted EP Impurity C (CAS 16051-77-7)
- Isosorbide Dinitrate Impurity 18 (Diluted with Lactose) (CAS 16908-90-0)
- Isosorbide Dinitrate EP Impurity B (CAS 16106-20-0)
- Isosorbide Dinitrate Impurity 28 (CAS CATO-C4X-223828)
- Isosorbide Dinitrate Impurity 10 (CAS CATO-C4X-223810)
- Isosorbide Dinitrate Impurity 11 (CAS 110627-22-0)
- Isosorbide Impurity 22 (CAS 110627-23-1)
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