Element provides residual solvents testing services in conformity with USP <467> and ICH Q3C methods.467>
Solvents are often necessary for the manufacture of drug products, as they can improve yield and solubility and enhance crystallization. However, depending on their toxicity and concentration, they can be harmful to the patient. Determination of residual solvents is critical to ensure that pharmaceutical raw materials and finished products are safe.
USP 460 and ICH Q3C
Element conducts residual solvent testing in compliance with USP <467> and ICH Q3C. Many residual solvents can be determined by USP <467> and ICH Q3C, while some require methods to be developed specifically and validated.
Our Engaged Experts also conduct residual solvents testing using our internal Gas Chromatography Mass Spectrometry (GC/MS) methods.
The Element advantage
Working closely with our clients, we look for potential sources of solvent contamination, and assist in working to eliminate these from your products. We also help to resolve difficult out of specification issues related to solvents. The USP <467> and ICH Q3C residual solvents methods can be performed on a rush basis to meet your business needs.
For more information about our residual solvents testing services, or to request a quote, contact us today.467>467>467>
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Trace Metal Services
Element is a recognized world-leader in trace metal analysis, providing testing for elemental impurities by ICPOES and ICPMS in compliance with USP , EP (2.4.20), and ICH Q3D guidelines.
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