Pimecrolimus Impurity 1 CAS 1025113-89-6

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.1025113-89-6
Molecular FormulaC42H66ClNO11
Molecular Weight796.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pimecrolimus Impurity 1 CAS 1025113-89-6 chemical structure

Description

As a certified reference material (CRM), Pimecrolimus Impurity 1 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.

Pimecrolimus Impurity 1 (CAS 1025113-89-6) is a certified pharmaceutical impurity reference standard with the molecular formula C42H66ClNO11 and a molecular weight of 796.43 g/mol.

Pimecrolimus Impurity 1 (C42H66ClNO11) 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. 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 FormulaC42H66ClNO11
Molecular Weight796.43 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
CAS Registry Year (est.)1988
Halogen ContentCl-containing
Nitrogen Atoms1

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