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Adrenaline impurities consist of synthetic intermediates, residual solvents, and degradation products formed under stress conditions such as oxidation, hydrolysis, and light exposure. As a sympathomimetic agent used in emergency medicine for anaphylaxis, cardiac arrest, and asthma, impurity profiling is essential to maintain therapeutic integrity and patient safety. Degradation pathways typically involve oxidative breakdown of the catechol moiety and hydrolytic cleavage of the side chain under acidic or photolytic conditions. All impurities are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.
Pharmacopeial and non-pharmacopeial Adrenaline 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.
Structurally related compounds and synthetic analogs associated with Adrenaline 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, genotoxicity assessments, and impurity threshold evaluations.
Adrenaline impurity reference standards are provided with validated analytical data including purity, NMR, MS, and full Certificates of Analysis. 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.
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