In the pharmaceutical field and especially according to the pharmacopeias, residual solvents are defined as volatile organic compounds that are utilized in the production of active ingredients and excipients, as well as the final pharmaceutical product.
Since residual solvents do not possess any therapeutic effect, they must be reduced as much as possible in the product. However, this is usually not completely possible considering the production process. For this reason, limit values are defined based on the toxicity of the individual solvent.
The corresponding specifications as well as the general methods for identifying and determining residual solvents are described in the pharmacopeias Ph. Eur. and USP/NF.
GBA Pharma offers a wide spectrum of possibilities to test for residual solvents according to Ph. Eur. 2.4.24 and USP <467>.
If you are interested in any of our services, then please feel free to contact one of our representatives.