Pitolisant Impurity 43 CAS 85356-69-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.85356-69-0
Molecular FormulaC9H10I2
Molecular Weight371.98 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitolisant Impurity 43 CAS 85356-69-0 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.

As a process- or degradation-related impurity, Pitolisant Impurity 43 (CAS 85356-69-0, C9H10I2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pitolisant Impurity 43 (C9H10I2) contains iodine substitution, an aromatic ring system. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

CATO manufactures Pitolisant Impurity 43 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 FormulaC9H10I2
Molecular Weight371.98 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1981
Halogen ContentI-containing

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