API IMPURITIES

API impurities are undesirable chemical substances structurally similar to drug molecules but distinct from the active pharmaceutical ingredient (API) itself. Impurity synthesis and identification are major activities at Orbiton. As a global impurity standard manufacturer and supplier, we possess extensive knowledge and understanding of the impurity synthesis process. Although impurities are our primary products, we also undertake custom synthesis projects under a CDA for gram-scale impurities synthesis. For custom impurity synthesis, we perform a comprehensive literature review, analyze the mechanistic aspects of the synthetic process, and synthesize and characterize these impurities using advanced techniques, including traditional forced degradation methods.
• Impurity isolation and purification
• Certified impurity standards
• Custom synthesis of impurities from milligrams to grams
• Structure elucidation of unknown impurities
• Over 2000 impurities in stock
• Cost-effective scientific solutions