Sapropterin

Sapropterin Impurities

Sapropterin impurities include synthetic intermediates, process-related compounds, degradation products, and nitrosamine derivatives that may arise during synthesis, formulation, or storage. As a synthetic form of tetrahydrobiopterin (BH4) used in the treatment of phenylketonuria (PKU), 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.

Sapropterin EP Impurities

Pharmacopeial and non-pharmacopeial Sapropterin 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.

Sapropterin Related Compounds

Structurally related compounds and synthetic analogs associated with Sapropterin 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.

Sapropterin Impurity Reference Standards

Sapropterin 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.