Tranexamic Acid EP Impurity E HCl CAS 157605-44-2

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.157605-44-2
Molecular FormulaC16H28N2O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tranexamic Acid EP Impurity E HCl CAS 157605-44-2 chemical structure

Description

As a process- or degradation-related impurity, Tranexamic Acid EP Impurity E HCl (CAS 157605-44-2, C16H28N2O3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Tranexamic Acid EP Impurity E HCl (C16H28N2O3HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, 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.

CATO manufactures Tranexamic Acid EP Impurity E HCl 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 FormulaC16H28N2O3 HCl
Molecular Weight332.87 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor)
Purity>90%
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)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)2002
Halogen ContentCl-containing
Nitrogen Atoms2

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