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Erythromycin impurities include process-related substances, degradation products, and structurally related analogs formed during fermentation, synthesis, or storage. As a macrolide antibiotic used to treat respiratory and skin infections, impurity control is essential for ensuring product safety, efficacy, and compliance with global regulatory standards. All impurity materials are structurally characterized and qualified under ICH guidelines.
We offer pharmacopeial and non-pharmacopeial impurity standards for Erythromycin that conform to European Pharmacopoeia (EP) specifications. These standards support method development, impurity profiling, 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 Erythromycin-related compounds such as fermentation by-products, synthetic intermediates, and degradation 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.
Erythromycin impurity reference standards are supplied 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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