Tacrolimus impurity 48 CAS CATO-C4X-130048

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-130048
Molecular FormulaC43H69NO11
Molecular Weight776.01 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tacrolimus impurity 48 CAS CATO-C4X-130048 chemical structure

Description

As a certified reference material (CRM), Tacrolimus impurity 48 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.

As a process- or degradation-related impurity, Tacrolimus impurity 48 (CAS CATO-C4X-130048, C43H69NO11) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Tacrolimus impurity 48 (C43H69NO11) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC43H69NO11
Molecular Weight776.01 g/mol
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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