Ranitidine EP Impurity I CAS 207592-21-0
| CAS No. | 207592-21-0 |
| Molecular Formula | C27H44N8O6S2 |
| Molecular Weight | 640.82 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Ranitidine EP Impurity I (CAS 207592-21-0, C27H44N8O6S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Ranitidine EP Impurity I is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 640.82 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
Physical & Chemical Properties
| Molecular Formula | C27H44N8O6S2 |
| Molecular Weight | 640.82 g/mol |
| Purity | >95% |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2016 |
| Nitrogen Atoms | 8 |
| Sulfur Atoms | 2 |
Related Ranitidine Standards
- Ranitidine EP Impurity A (CAS 72126-78-4)
- Ranitidine Impurity 12 (CAS CATO-C4X-137012)
- Ranitidine Impurity 21 (CAS 112233-25-7)
- Ranitidine EP Impurity J (CAS 1331637-48-9)
- Ranitidine N,S-Dioxide (CAS 1185237-42-6)
- Ranitidine Impurity 1 (CAS 72115-14-1)
- Ranitidine EP Impurity C (CAS 73851-70-4)
- Ranitidine EP Impurity E (CAS 73857-20-2)
Recommended Standards
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- Capecitabine Impurity 27 (CAS 13007-50-6)
- 2-(5-(3,4-Dimethylphenyl)oxazol-2-yl)ethan-1-amine (CAS 1017366-13-0)
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