Determination of residual solvents

Purpose

Residual solvent analysis aims to ensure the safety, quality and regulatory compliance of products and processes where organic solvents are used.  

The analysis is a tool in, for example, work to protect health and the environment, to maintain high product quality and to comply with laws and standards, especially in the areas of pharmaceuticals, food, chemistry and the environment.  

Areas of application 

• Safety. Organic solvents can cause negative effects on health and the environment. The analysis ensures that the levels are below permitted limits.
  • Monitoring: Analysis of solvent residues as part of the monitoring of solvent emissions and exposures to protect the environment and personnel                                                                                       
• Quality control. Residues of solvents in a product can affect the stability, taste, smell or function of the product. Analysis verifies that manufacturing produces a clean and consistent product.
  • Pharmaceuticals: Ensuring that the active substance and finished product do not contain harmful levels of residual solvents from the manufacturing process
  • Food and packaging: Control of solvents from printing inks and adhesives in the packaging that can migrate to the food                                                                                                              
• Regulatory compliance. Legislation and guidelines, such as ICH Q3C for pharmaceuticals or food law within EU, set maximum limits for residual solvents. Analysis is required to demonstrate compliance.                    
• Process optimisation. The analysis results can be used to improve process steps such as drying or purification in a manufacturing process, to reduce solvent residues and make the process more efficient.

Method

Gas chromatography (GC) is the standard method for the analysis of solvent residues. The most widely used technique is Headspace GC (HS GC), where a dissolved sample is heated and volatile organic solvents are analyzed in the gas phase. The most common detection technique is Flame Ionisation Detection (FID).   

The method is quantitative, robust, highly reproducible and standard in quality control QC. Furthermore, the method is very sensitive, solvent concentrations at ppm and down to ppb levels can be analysed, and it is suitable for volatile and semi volatile organic solvents.  

RISE performs both GMP analyses according to ICH Guidelines (ICH Q3C), analyses according to Ph Eur 2.4.24 and exploratory analyses for research and development purposes.  

Delivery

Results are reported in agreement with the customer, for example in the form of a written report, or a Certificate of Analysis CoA, or as a table with raw data.