Residual Solvent Testing

Solvents are a necessary part of pharmaceutical manufacturing. Residual solvents in pharmaceutical products are organic volatile compounds used or generated in the manufacture of drug substances or excipients, in the preparation of drug products, or from packaging and storage. Removing them is an important part of the process to ensure that pharmaceuticals do not contain toxic volatile organic compounds, so verification of this removal plays an important role. At BOC Sciences, our skilled analysts have extensive experience in using wet chemistry to analyze pharmaceutical products for residual solvent testing. and can test your raw materials, intermediates and final products at any stage of development. We offer a comprehensive residual solvent analysis program for pharmaceutical substances (APIs), drug products and excipients.

Our Services

Drug substances, excipients and drug products should be tested for residual solvents when the production or purification process is known to result in the presence of residual solvents. Only residual solvents used or generated during the production or purification process are necessary to be tested. Therefore, residual solvent analysis is a very important quality control procedure in the pharmaceutical industry. BOC Sciences has established a comprehensive analytical laboratory that offers complete wet chemistry residual solvent testing. We have introduced a number of techniques for different application to measure the residual amounts of these solvents.

• USP<467>Methods
• Sampling: static headspace sampling method
• Analysis: GC/FID (flame ionization detector) using dedicated columns. GC/MS (mass detection) can also be used for residual solvent analysis
• For solvents that are not listed, we can develop new methods to identify and quantify residual solvents (RS) or organic volatile impurities (OVI) in your formulations
• Our toxicologists can determine the permissible daily exposure (PDE) of your materials
• Analysis of finished formulations and component substances

Figure 2. Water and DMSO in Residual Solvent Analysis by GC-VUV (class 2 solvents). (Jack, C. 2017)

We offer robust testing for all types of solvents to help you quickly ensure the safety and quality of your pharmaceutical products:

• Class 1 solvents

Solvents to be avoided: known human carcinogens, strongly suspected human carcinogens, and environmentally hazardous solvents

• Class 2 solvents

Solvents to be restricted: on-genotoxic animal carcinogenss or other possible pathogens of irreversible toxicity, such as neurotoxic or teratogenic, other significant but reversible toxicity

• Class 3 solvents

Solvents with low toxicity potential: solvents with low toxic potential for humans

BOC Sciences can test for a variety of solvents. Contact us to learn about our capabilities for solvents not on this list.

Why Choose Us?

• As the world's leading supplier of pharmaceutical residue impurity testing and residue solvent analysis, we provide you with the experience, technology and regulatory expertise you need
• Our teams can provide you with a wide range of state-of-the-art chromatography and mass spectrometry instruments, as well as extensive method development experience, which are used to optimize analytical methods for residue solvent analysis.
• Our comprehensive wet chemistry testing capabilities can simplify your residual solvent testing process
• Our experts can screen, confirm, identify and quantify multiple solvent classes