Ursodeoxycholic Acid impurity 72 CAS 2168516-46-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2168516-46-7
Molecular FormulaC25H40O6
Molecular Weight436.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ursodeoxycholic Acid impurity 72 CAS 2168516-46-7 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 Ursodeoxycholic Acid impurity 72.

CATO supplies Ursodeoxycholic Acid impurity 72 (CAS 2168516-46-7), a pharmacopoeial impurity reference standard (molecular formula C25H40O6, MW 436.58 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ursodeoxycholic Acid impurity 72 (C25H40O6) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 436.58 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), Ursodeoxycholic Acid impurity 72 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 FormulaC25H40O6
Molecular Weight436.58 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1998

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