(3R,5S)-Atorvastatin EP Impurity B (single configuration) Calcium salt CAS 651770-09-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.651770-09-1
Molecular Formula2*C33H34FN2O5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

(3R,5S)-Atorvastatin EP Impurity B (single configuration) Calcium salt CAS 651770-09-1 chemical structure

Description

The occurrence of (3R,5S)-Atorvastatin EP Impurity B (single configuration) Calcium salt is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies (3R,5S)-Atorvastatin EP Impurity B (single configuration) Calcium salt (CAS 651770-09-1), a pharmacopoeial impurity reference standard (molecular formula C33H34FN2O5Ca, MW 597.72 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C33H34FN2O5Ca, (3R,5S)-Atorvastatin EP Impurity B (single configuration) Calcium salt contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 597.72 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), (3R,5S)-Atorvastatin EP Impurity B (single configuration) 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.

Physical & Chemical Properties

Molecular Formula2*C33H34FN2O5 Ca
Molecular Weight597.72 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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)17.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1985
Halogen ContentF-containing
Nitrogen Atoms2

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