Ritonavir Impurity 46 CAS 1010809-54-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1010809-54-7
Molecular FormulaC32H42N4O8S
Molecular Weight642.76 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ritonavir Impurity 46 CAS 1010809-54-7 chemical structure

Description

Ritonavir Impurity 46 (CAS 1010809-54-7) is a certified pharmaceutical impurity reference standard with the molecular formula C32H42N4O8S and a molecular weight of 642.76 g/mol.

Ritonavir Impurity 46 (C32H42N4O8S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Ritonavir Impurity 46 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 FormulaC32H42N4O8S
Molecular Weight642.76 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
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Nitrogen Atoms4
Sulfur Atoms1

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