Amitriptyline EP Impurity A CAS 1210-35-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1210-35-1
Molecular FormulaC15H12O
Molecular Weight208.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amitriptyline EP Impurity A CAS 1210-35-1 chemical structure

Description

As a process- or degradation-related impurity, Amitriptyline EP Impurity A (CAS 1210-35-1, C15H12O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Amitriptyline EP Impurity A (C15H12O) contains a hydroxyl group, an ether linkage, a polycyclic aromatic system. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC15H12O
Molecular Weight208.26 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957

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