Rosuvastatin EP Impurity J (Sodium Salt) CAS 2226413-62-1(Free Acid)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2226413-62-1(Free Acid)
Molecular FormulaC38H43F2N6O8S2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rosuvastatin EP Impurity J (Sodium Salt) CAS 2226413-62-1(Free Acid) 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 FormulaC38H43F2N6O8S2 Na
Molecular Weight836.90 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay 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 AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms6
Sulfur Atoms2

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