Pimecrolimus Impurity 12 CAS CATO-C4X-173112

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-173112
Molecular FormulaC43H68ClNO11
Molecular Weight810.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pimecrolimus Impurity 12 CAS CATO-C4X-173112 chemical structure

Description

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.

Pimecrolimus Impurity 12 (CAS CATO-C4X-173112) is a certified pharmaceutical impurity reference standard with the molecular formula C43H68ClNO11 and a molecular weight of 810.45 g/mol.

Pimecrolimus Impurity 12 (C43H68ClNO11) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

As a certified reference material (CRM), Pimecrolimus Impurity 12 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 FormulaC43H68ClNO11
Molecular Weight810.45 g/mol
Purity>90%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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