Rosuvastatin EP Impurity J (Sodium Salt) CAS 2226413-62-1(Free Acid)
| CAS No. | 2226413-62-1(Free Acid) |
| Molecular Formula | C38H43F2N6O8S2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Rosuvastatin EP Impurity J (Sodium Salt) 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.
As a process- or degradation-related impurity, Rosuvastatin EP Impurity J (Sodium Salt) (CAS 2226413-62-1(Free Acid), C38H43F2N6O8S2Na) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C38H43F2N6O8S2Na, Rosuvastatin EP Impurity J (Sodium Salt) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 836.90 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C38H43F2N6O8S2 Na |
| Molecular Weight | 836.90 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 19.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 6 |
| Sulfur Atoms | 2 |
Related Rosuvastatin Standards
- Rosuvastatin Impurity 205 (CAS 1007871-85-3)
- Rosuvastatin EP Impurity L Calcium(Mixture of Diastereomers) (CAS 1024064-70-7)
- Rosuvastatin Impurity 267 (CAS 1031246-43-1)
- Rosuvastatin Impurity 19 (CAS 1035595-71-1)
- Rosuvastatin Impurity 27 (CAS 1044518-75-3)
- Rosuvastatin Impurity 192 (CAS 1092844-00-2)
- Rosuvastatin Impurity 123 (CAS 1112048-62-0)
- Rosuvastatin Impurity 37 (CAS 1197348-98-3)
Recommended Standards
- Colesevelam Amino Dihexylquat Impurity HBr (Amino Dihexyltrimethylammonium Bromide HBr) (CAS 2170771-70-5)
- Ibuprofen impurity 142 (CAS 3585-52-2（free base))
- Perampanel Impurity 35 (CAS CATO-C4X-243035)
- N,N-dimethylpiperidine-3-carboxamide hydrochloride (CAS 112950-94-4)
- 4-Iodo-3-nitro-1H-pyrazole-5-carboxylic acid (CAS 1621909-80-5)
- 3-Amino-N-(2-methylphenyl)benzenesulfonamide (CAS 847171-68-0)
- N-Mesityl-3-oxobutanamide (CAS 19359-16-1)
- (S)-5-Cbz-5-Aza-spiro[2.4]heptane-7-carboxylic acid (CAS 2097073-15-7)
- (S)-Fmoc-2-amino-5-(N'-Pbf-N''-trifluoroethyl-guanidino)-pentanoic acid (CAS 1060769-47-2)
- PACAP-Related Peptide (PRP), rat (CAS 132769-35-8)
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