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Ertugliflozin impurities include process-related substances, degradation products, and structurally related analogs formed during synthesis or storage. As a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of type 2 diabetes mellitus, impurity profiling is essential for ensuring product safety, efficacy, and regulatory compliance. All materials are structurally characterized and qualified under ICH guidelines.
We offer pharmacopeial and non-pharmacopeial impurity standards for Ertugliflozin that align with European Pharmacopoeia (EP) specifications. These standards support method development, routine quality control, and stability testing. EP traceable entries are available upon request and are supplied with validated analytical data including purity, identity, and structural confirmation.
Our catalog includes Ertugliflozin-related compounds such as synthetic intermediates, degradation products, and structural analogs. These compounds are used in forced degradation studies, impurity identification, and genotoxicity assessments. All entries are supported by comprehensive analytical documentation and meet international regulatory expectations.
Ertugliflozin impurity reference standards are provided with full analytical characterization including HPLC purity, NMR, and MS data. These standards are suitable for pharmaceutical R&D, method validation, and GMP-compliant quality control. EP/USP traceable materials are available upon request. All products are re-tested periodically to ensure consistency and reliability.
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