Acarbose

Acarbose Impurities

Acarbose is a complex oligosaccharide derived from microbial fermentation, primarily used as an alpha-glucosidase inhibitor for managing type 2 diabetes. Its impurity profile includes structurally related saccharide analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis and oxidation. Degradation pathways typically involve cleavage of glycosidic bonds and oxidation of hydroxyl groups, especially under acidic or enzymatic conditions. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Acarbose EP Impurities

Pharmacopeial and non-pharmacopeial Acarbose impurity compounds 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.

Acarbose Related Compounds

Structurally related compounds and fermentation-derived analogs associated with Acarbose are included for use in 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.

Acarbose Impurity Reference Standards

Acarbose 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.