Mycophenolate Mofetil Impurity 16 CAS 32483-51-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.32483-51-5
Molecular FormulaC19H24O6
Molecular Weight348.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mycophenolate Mofetil Impurity 16 CAS 32483-51-5 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 Mycophenolate Mofetil Impurity 16.

CATO supplies Mycophenolate Mofetil Impurity 16 (CAS 32483-51-5), a pharmacopoeial impurity reference standard (molecular formula C19H24O6, MW 348.39 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Mycophenolate Mofetil Impurity 16 (C19H24O6) contains a flavonoid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 348.39 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC19H24O6
Molecular Weight348.39 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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1966

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