Methylprednisolone Impurity 1 CAS CATO-C4X-19191

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-19191
Molecular FormulaC26H32O8
Molecular Weight472.53 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Methylprednisolone Impurity 1 CAS CATO-C4X-19191 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 Methylprednisolone Impurity 1.

Methylprednisolone Impurity 1 (CAS CATO-C4X-19191) is a certified pharmaceutical impurity reference standard with the molecular formula C26H32O8 and a molecular weight of 472.53 g/mol.

Based on its molecular formula C26H32O8, Methylprednisolone Impurity 1 contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 472.53 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Methylprednisolone Impurity 1 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 FormulaC26H32O8
Molecular Weight472.53 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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