Nicotine

Nicotine Impurities

Nicotine impurities include biosynthetic analogs, process-related compounds, and degradation products that may arise during extraction, synthesis, formulation, or storage. As a naturally occurring alkaloid used in smoking cessation therapies and nicotine replacement products, impurity profiling is essential to ensure product safety, pharmacological consistency, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Nicotine EP Impurities

Pharmacopeial and non-pharmacopeial Nicotine 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.

Nicotine Related Compounds

Structurally related compounds and biosynthetic derivatives associated with Nicotine are included for use in impurity identification, toxicological qualification, and regulatory submission. All related substances are supported by comprehensive analytical documentation and conform to international standards.

Nicotine Impurity Reference Standards

Nicotine 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.