Residual solvent (RS) and organic volatile impurities (OVI) identification and quantification in pharmaceutical drug substances, excipients and products
Solvents are often necessary for the manufacture of active pharmaceutical ingredients (APIs) or drug substances and excipients used in the formulation of various drug products. Control of solvents in the finished drug product is required by various regulatory agencies worldwide, as they provide no therapeutic benefit and may actually be harmful.
There are literally hundreds of solvents that are employed in the manufacture of pharmaceutical articles. ICH guideline Q3C (R5) and USP chapter <467> provide permissible daily exposure (PDE) for some of the commonly used solvents. USP <467> and Ph. Eur. 5.4 provide analytical methods for the analysis for the commonly used solvents. If a solvent other than those listed in the ICH Q3C (R5) or USP <467> is utilized in the manufacture of a pharmaceutical article then the onus falls on the drug product manufacturer to determine the acceptable PDE and establish a suitable analytical procedure for the control of that solvent.
We provide expert determination and identification of residual solvents in pharmaceutical articles, helping customers ensure that residual solvents have been reduced to acceptable levels in drug products, drug substances and excipients. Often it is prudent to ensure residual solvents are controlled for all excipients and the drug substance(s) in order to ensure that the finished product will meet the limits specified in ICH Q3C(R5) or USP <467> or the limit established by the drug product manufacturer for unique solvent(s).
Our Good Manufacturing Practice (cGMP) laboratories routinely conduct residual solvent testing in accordance with pharmacopoeia methods, in particular USP <467>, and Ph. Eur. 5.4 for residual solvents. Additionally, we are also able to develop and validate tailored methods that will meet your specific needs using a range of chromatographic techniques such as headspace gas chromatography or gas chromatography - mass spectrometry (GC-MS). Our pharmaceutical analysis experts conduct residual solvent method validation which conforms to ICH Q2 (R1) guidelines on validation of analytical procedures. The accurate and robust data generated for residual solvents can help you to make an appropriate risk-based assessment for your finished drug product(s).
Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards. As a trusted provider of residual solvents determination from our network of GMP laboratories, we offer you extensive expertise for pharmaceutical impurity analysis, underpinned by with a broad range of analytical techniques to suit your particular needs.
Organic Volatile Impurity Analytical Capabilities
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