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SQ109 impurities include synthetic intermediates, process-related compounds, degradation products, and potential nitrosamine contaminants that may arise during synthesis, formulation, or storage. As an investigational ethylenediamine-based antitubercular agent targeting MmpL3 in Mycobacterium tuberculosis, impurity profiling is essential to ensure product safety, therapeutic consistency, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.
Pharmacopeial and non-pharmacopeial SQ109 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 SQ109 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.
SQ109 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. Traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.
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