Residual solvent analysis of pharmaceutical products in accordance with the ICH Q3C guideline
Your needs: reliably analyze residual solvents in your pharmaceutical products to meet ICH Q3C requirements
What is ICH Q3C?
The ICH (International Conference on Harmonisation) Q3C guideline provides recommendations on toxicologically acceptable concentrations, for patient safety, of residual solvents (or volatile residual impurities) in pharmaceutical products.
Thus, the ICH Q3C guideline classifies residual solvents into three categories according to their toxicological risk to humans:
What is a residual solvent according to ICH Q3C?
Residual solvents in pharmaceutical products are defined as volatile organic chemicals used or produced during the manufacture of pharmaceutical products or drug substances (benzene, acetone, cyclohexane, toluene, 1,4-dioxane, etc.).
Residual solvents provide no therapeutic benefits. However, an organic solvent may be used in pharmaceutical manufacturing to improve production yield, or to establish the physicochemical properties of a substance or pharmaceutical product (such as purity, crystallinity, or solubility).
Consequently, finding residual solvents in pharmaceutical products is not impossible, particularly because certain manufacturing techniques do not completely eliminate them.
How can residual solvents be identified and quantified in pharmaceutical products?
Residual solvents are usually isolated using separation techniques such as gas chromatography coupled with mass spectrometry (GC-MS). Wherever possible, harmonized methods described in pharmacopoeias (USP 467) should be used to determine residual solvent concentrations. Otherwise, the selected analytical method must undergo appropriate validation.
Validation of residual solvent analytical methods must comply with the guidelines set out in the ICH Q2 documents (USP 467).
Conducting regular checks helps prevent production incidents and ensures continued compliance with evolving pharmaceutical specifications.
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FILAB laboratory supports you in analyzing residual solvents in your pharmaceutical products in accordance with ICH Q3C
Our ICH Q3C solvent analysis services
For over 30 years, our FILAB laboratory has had the experience and dedicated analytical facilities to support pharmaceutical companies today with residual solvent analysis in accordance with the ICH Q3C guideline, through tailored support.
Working with a laboratory of experts in ICH Q3C solvent analysis, such as FILAB, makes it easier to understand the strategic challenges and changes affecting the pharmaceutical industry.
The FILAB laboratory supports pharmaceutical companies with pharmaceutical stability testing and the detection of residual solvents in pharmaceutical products and substances, using its GC-MS and HS-GC-MS equipment, along with expertise in pharmaceutical analysis.
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