Dutasteride EP Impurity I CAS 1648593-70-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1648593-70-7
Molecular FormulaC46H55F6N3O4
Molecular Weight827.94 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dutasteride EP Impurity I CAS 1648593-70-7 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 827.94 g/mol gives Dutasteride EP Impurity I distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Dutasteride EP Impurity I (CAS 1648593-70-7) is a certified pharmaceutical impurity reference standard with the molecular formula C46H55F6N3O4 and a molecular weight of 827.94 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Dutasteride EP Impurity I is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 827.94 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Dutasteride EP Impurity I 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 FormulaC46H55F6N3O4
Molecular Weight827.94 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)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Halogen ContentF-containing
Nitrogen Atoms3

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