Residual solvents are trace-level chemical residues in drug substances and drug products that are byproducts of manufacturing, or that form during packaging and storage. It is the responsibility of the drug manufacturers to ensure that these residues are removed, or are present only in limited concentrations.

The United States Pharmacopeia (USP) recently revised General Chapter <467> on residual solvent analysis by adopting the International Committee on Harmonization (ICH) Q3C guidelines. The new revisions also include analytical methodologies for the identification, control and quantification of residual solvents that are adapted from the European Pharmacopoeia (EP). This revision, effective July 1, 2008, replaces previous methods and significantly increases the requirements with which a pharmaceutical company must comply in order to demonstrate that all drug products (not just new) are compliant with Chapter <467> limits. The change increases the number of solvents requiring testing from seven to fifty-nine.

While most companies have extensive data on the solvents used in the manufacturing of their API, the information regarding solvents present in the excipients is usually much lower. It is the responsibility of the drug product manufacturer to control the limit of solvents.

Testing is only required for those solvents used in the manufacturing or purification process of drug substances, excipients or products. This allows each company to determine which solvents it uses in production and develop testing procedures that address their specific needs.
Solvents have been classified based on their potential health risks into three main categories:

• Class 1: Solvents should not be used because of the unacceptable toxicities or deleterious environmental effects
• Class 2: Solvents should be limited because of inherent toxicities
• Class 3: Solvents may be regarded as less toxic and of lower risk to human health

The Overbrook HT200 Headspace Autosampler has been specially designed to fit the needs of General Chapter <467>. The sensitivity and reproducibility have been exhaustively evaluated at multiple locations around the world to ensure consistent method. We have also demonstrated performance characteristics for drug substances, excipients and drug products. All show extremely consistent data.

The HT200 is a compact unit that mounts easily to the top of any GC system, making it an easy add on for any pharmaceutical company. Due to it’s ruggedness, it has been recently featured in USP training courses around the world, offering a cost effective turn-key solution to General Chapter <467>. The units are set up and working within 1-day of arrival at the laboratory.

Fore more information about HT200H Autosampler, visit www.overbrookscientific.com. For more information about the USP <467> training seminars, which feature the HT200H Autosampler, visit www.usp.org.

Also, contact our Marketing Department (info@overbrookscientific.com) to recieve copies of the monograph and chromatograms featuring the HT200H