Isotretinoin (13-cis-retinoic acid) is a retinoid used in the treatment of severe recalcitrant nodular acne. Its impurity profile includes structurally related analogs, residual solvents, and degradation products. The pharmaceutical impurities can be formed under stress conditions such as hydrolysis, oxidation, and photolysis. Typical degradation pathways of Isotretinoin may involve oxidative breakdown of the polyene chain, isomerization to other retinoic acid forms (e.g., all-trans-retinoic acid), and rearrangement of substituents within the retinoid scaffold. These impurities may affect the potency, stability, and safety of the drug. Thus, all impurities related to Isotretinoin must be structurally characterized and qualified according to ICH guidelines for toxicological assessment and analytical validation.
We provide the pharmacopeial and non-pharmacopeial Isotretinoin impurity compounds that are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.
Structurally related compounds and synthetic analogs of Isotretinoin are included for impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.
We also supply the Isotretinoin impurity reference standards, which 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. The EP/USP traceable products are available upon request and are routinely re-tested to ensure consistency and reliability.
Register to add the product to RFQ list
Already have an account? Log in here
Don’t have an account? Register here
