Sofosbuvir Impurity 70 CAS 1334513-02-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1334513-02-8
Molecular FormulaC18H17F5NO5P
Molecular Weight453.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sofosbuvir Impurity 70 CAS 1334513-02-8 chemical structure

Description

Sofosbuvir Impurity 70 (CAS 1334513-02-8) is a certified pharmaceutical impurity reference standard with the molecular formula C18H17F5NO5P and a molecular weight of 453.30 g/mol.

Structurally, Sofosbuvir Impurity 70 (C18H17F5NO5P) contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.5, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 453.30 g/mol, it falls into the moderately-high-molecular-weight range. 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), Sofosbuvir Impurity 70 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 FormulaC18H17F5NO5P
Molecular Weight453.30 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentF-containing
Nitrogen Atoms1

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