Ranitidine Hydrochloride EP Impurity B CAS 91224-69-0
| CAS No. | 91224-69-0 |
| Molecular Formula | C10H18N2OS |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Ranitidine Hydrochloride EP Impurity B is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Ranitidine Hydrochloride EP Impurity B (CAS 91224-69-0, C10H18N2OSC4H4O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Ranitidine Hydrochloride EP Impurity B (C10H18N2OSC4H4O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
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 | C10H18N2OS C4H4O4 |
| Molecular Weight | 330.40 g/mol |
| Purity | 97%+ |
| 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 |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1983 |
| Nitrogen Atoms | 2 |
| Sulfur Atoms | 1 |
Related Ranitidine Standards
- Ranitidine Impurity 11 (CAS 102721-76-6)
- Ranitidine Impurity 13 (CAS 112233-24-6)
- Ranitidine Impurity 21 (CAS 112233-25-7)
- Ranitidine Impurity 10 (CAS 113224-25-2)
- Ranitidine EP Impurity D (CAS 117846-02-3)
- Ranitidine N,S-Dioxide (CAS 1185237-42-6)
- Ranitidine-d6 HCl (CAS 1185238-09-8)
- Ranitidine-D6 (CAS 1185514-83-3)
Recommended Standards
- Mesna impurity 15 (CAS CATO-C4X-169215)
- Calcium Dobesilate Impurity N1 (CAS 6409-58-1)
- Esomeprazole Impurity 73 (CAS CATO-C4X-111273)
- Sodium-N-methyl-N-tall oil taurate (CAS 61791-41-1)
- 2-((5-(3-Chlorophenyl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)-N-(3,4-dimethylphenyl)acetamide (CAS 882749-08-8)
- 3-Cyclopropyl-4-ethyl-2-oxopyrrolidine-3-carbonitrile (CAS 1462290-17-0)
- 3-Amino-N-(5-chloro-2-methoxyphenyl)-6-ethyl-4-(trifluoromethyl)-5,6,7,8-tetrahydrothieno[2,3-b]quinoline-2-carboxamide (CAS 939888-82-1)
- N-(9-(2-Oxopropyl)-9H-purin-6-yl)acetamide (CAS 105970-01-2)
- Nintedanib Impurity 174 (CAS CATO-C4X-1814174)
- Neuropeptide Y, human (CAS 98264-90-5)
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