Clearsynth is a leading innovator in pharmaceutical reference standards, offering high-quality Reference Standards for Amberlite, including both pharmacopeial and non-pharmacopeial impurities, metabolites, stable isotope products, and nitrosamines (N-NO products). Our Amberlite impurity reference standards are invaluable for pharmaceutical research, supporting product development, ANDA and DMF submissions, quality control (QC), method validation, and stability studies. They also aid in identifying unknown impurities and assessing genotoxic potential.
Our Amberlite-related products undergo thorough characterization and are supplied with detailed Certificates of Analysis (COA) and analytical data that meet regulatory requirements. All supplied products are re-tested at regular intervals to ensure ongoing quality and compliance.
