Atorvastatin EP Impurity C Calcium Salt CAS 693793-53-2

Purity >80%In StockPharmacopoeial Impurity Standards
CAS No.693793-53-2
Molecular Formula2*C33H33F2N2O5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Atorvastatin EP Impurity C Calcium Salt CAS 693793-53-2 chemical structure

Description

As a certified reference material (CRM), Atorvastatin EP Impurity C Calcium 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, Atorvastatin EP Impurity C Calcium Salt (CAS 693793-53-2, C33H33F2N2O5Ca) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Atorvastatin EP Impurity C Calcium Salt (C33H33F2N2O5Ca) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 17.5, corresponding to approximately 17 ring(s) or double-bond equivalent(s). With a molecular weight of 615.71 g/mol, it falls into the high-molecular-weight range. 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 Formula2*C33H33F2N2O5 Ca
Molecular Weight615.71 g/mol
Purity>80%
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)17.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1985
Halogen ContentF-containing
Nitrogen Atoms2

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