地芬尼多杂质4盐酸盐 CAS 94908-95-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.94908-95-9
Molecular FormulaC11H21N
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

地芬尼多杂质4盐酸盐 CAS 94908-95-9 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 地芬尼多杂质4盐酸盐.

As a process- or degradation-related impurity, 地芬尼多杂质4盐酸盐 (CAS 94908-95-9, C11H21NHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

地芬尼多杂质4盐酸盐 (C11H21NHCl) contains chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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.

As a certified reference material (CRM), 地芬尼多杂质4盐酸盐 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 FormulaC11H21N HCl
Molecular Weight203.75 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1984
Halogen ContentCl-containing
Nitrogen Atoms1

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