Residual solvents in pharmaceuticals are organic volatile or semi-volatile impurities left over from the synthesis of active pharmaceutical ingredients (APIs), from the manufacturing process of the final pharmaceutical products or from packaging and storage. Depending on the toxicity, residual solvents in pharmaceutical pose a severe risk for the patient. They also have a potential impact on the crystalline form, possibly affecting solubility, stability, and bioavailability. Therefore, it is required to closely monitor and control the residual solvents in all drug substances, excipients in drug formulations, and drug products.
Honeywell Chromasolv™ GC-headspace solvents were developed particularly for the identification and quantification of residual solvents in pharmaceuticals using GC-headspace methods described in monographs from the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.) and following the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.
Accurate and reliable GC-headspace analysis requires the use of very pure solvents with extremely low concentrations of the defined residual solvents. Honeywell ensures this high purity through special, state-of-theart production and application tests, hence we can consistently deliver the reliability, accuracy and analytical safety you need. The preferred solvent choice for GC headspace analysis is water due to ease of handling and the fact that it is non-toxic. But not all samples are soluble in water, therefore organic solvents with low volatility and a high boiling point, such as dimethyl sulfoxide (DMSO) and dimethylformamide (DMF) may be required.