Loratadine EP Impurity E CAS 170727-59-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.170727-59-0
Molecular FormulaC22H23ClN2O2
Molecular Weight382.88 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Loratadine EP Impurity E CAS 170727-59-0 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 Loratadine EP Impurity E.

As a process- or degradation-related impurity, Loratadine EP Impurity E (CAS 170727-59-0, C22H23ClN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Loratadine EP Impurity E (C22H23ClN2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 382.88 g/mol, it falls into the moderately-high-molecular-weight range. 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).

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.

CATO manufactures Loratadine EP Impurity E under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC22H23ClN2O2
Molecular Weight382.88 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2005
Halogen ContentCl-containing
Nitrogen Atoms2

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