Tiropramide Impurity B CAS 57227-08-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.57227-08-4
Molecular FormulaC29H32N2O4
Molecular Weight472.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tiropramide Impurity B CAS 57227-08-4 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 Tiropramide Impurity B.

CATO supplies Tiropramide Impurity B (CAS 57227-08-4), a pharmacopoeial impurity reference standard (molecular formula C29H32N2O4, MW 472.58 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Tiropramide Impurity B is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 472.58 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Tiropramide Impurity B 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 FormulaC29H32N2O4
Molecular Weight472.58 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Nitrogen Atoms2

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