Betamethasone EP Impurity I CAS 185613-69-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.185613-69-8
Molecular FormulaC22H29FO5
Molecular Weight392.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Betamethasone EP Impurity I CAS 185613-69-8 chemical structure

Description

As a certified reference material (CRM), Betamethasone 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.

CATO supplies Betamethasone EP Impurity I (CAS 185613-69-8), a pharmacopoeial impurity reference standard (molecular formula C22H29FO5, MW 392.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C22H29FO5, Betamethasone EP Impurity I contains a flavonoid core, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 392.46 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

Physical & Chemical Properties

Molecular FormulaC22H29FO5
Molecular Weight392.46 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2010
Halogen ContentF-containing

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