Prednisone EP Impurity C CAS 70522-55-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.70522-55-3
Molecular FormulaC21H24O5
Molecular Weight356.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Prednisone EP Impurity C CAS 70522-55-3 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Prednisone EP Impurity C.

As a process- or degradation-related impurity, Prednisone EP Impurity C (CAS 70522-55-3, C21H24O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a flavonoid core, a hydroxyl group, an ether linkage, Prednisone EP Impurity C is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 356.41 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Prednisone EP Impurity C 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 FormulaC21H24O5
Molecular Weight356.41 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, 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
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1977

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