Ranitidine EP Impurity D HCl CAS CATO-C4X-13704
| CAS No. | CATO-C4X-13704 |
| Molecular Formula | C12H19N3O4S |
| Molecular Weight | N/A |
| 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 D HCl (CAS CATO-C4X-13704, C12H19N3O4SHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C12H19N3O4SHCl, Ranitidine EP Impurity D HCl contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 337.82 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
Physical & Chemical Properties
| Molecular Formula | C12H19N3O4S HCl |
| Molecular Weight | 337.82 g/mol |
| Purity | >95% |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
| 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
- Donepezil impurity 32 (CAS 120014-07-5)
- Hydroxychloroquine R-isomer Impurity (CAS 137433-23-9)
- Tetrabenazine Impurity 3 (CAS 99672-64-7)
- 4-Methyl-N-(4-nitrophenyl)-N-(p-tolyl)aniline (CAS 20440-92-0)
- 1H-Pyrazolo[4,3-d]pyrimidin-7(7aH)-one (CAS 179042-24-1)
- 3-(Benzo[b]thiophen-3-yl)morpholine (CAS 1270538-13-0)
- 3-(Thiophen-2-yl)-1,2,4-oxadiazole-5-thiol (CAS 1340404-47-8)
- 4-Phenylpiperazine-1-carboximidamide (CAS 17238-58-3)
- (S)-4-(2-Chloro-6-(iodomethyl)pyrimidin-4-yl)-3-methylmorpholine, 97% (CAS 1009628-22-1)
- Stresscopin-Related Peptide (human) (CAS 348626-74-4)
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