Nortriptyline

Nortriptyline Impurities

Nortriptyline impurities include synthetic intermediates, degradation products, and structurally related tricyclic analogs that may arise during synthesis, formulation, or storage. As a second-generation tricyclic antidepressant used in the treatment of major depressive disorder and neuropathic pain, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Nortriptyline EP Impurities

Pharmacopeial and non-pharmacopeial Nortriptyline impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and stability testing. EP traceable materials are supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Nortriptyline Related Compounds

Structurally related compounds and biosynthetic analogs associated with Nortriptyline are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, HPLC method development, and impurity threshold assessments.

Nortriptyline Impurity Reference Standards

Nortriptyline impurity reference standards are provided with validated analytical data including purity, NMR, and MS. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.