Labeled solvents that comply with multiple pharmacopeial standards—such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), BP (British Pharmacopoeia), JP (Japanese Pharmacopoeia), and Multi-Compendial standards—are essential in pharmaceutical, biotechnology, and analytical laboratories.
Pharmaceutical impurities are unwanted chemicals that remain in Active Pharmaceutical Ingredients (APIs) or finished drug products. Regulatory authorities such as ICH (International Council for Harmonisation), USP, EP, BP, and JP provide guidelines for controlling these impurities to ensure drug safety and efficacy.
Nitrosamine impurities are genotoxic and potentially carcinogenic compounds found in pharmaceuticals, primarily due to process-related contamination or environmental exposure. Regulatory authorities such as the FDA, EMA, ICH, and WHO have established stringent guidelines to detect, control, and mitigate nitrosamine impurities in drugs.
Inductively Coupled Plasma (ICP), Atomic Absorption Spectroscopy (AAS), and Ion Chromatography (IC) Reference Standards are high-purity calibration materials used to ensure accurate quantification of trace elements and ions in various samples.
