Swab / Direct Combustion Carbon Analysis of Drug Residue by TOC


Cleaning validation for production equipment at pharmaceutical facilities is an important process for ensuring quality control and safety. HPLC is often used for evaluation and testing, but can become complicated and time-consuming when sample preparation requires the use of solvent extraction or enrichment, etc. An alternative is the swab/direct combustion carbon analysis method using a Total Organic Carbon (TOC) Analyzer in concert with a Solid Sample Combustion Unit. An example of this method, which enables quick, accurate measurement even when there are insoluble residues, is introduced here.


Lancaster Labs offers Melamine testing


Lancaster Laboratories has developed and validated a new method for detecting melamine in pharmaceutical products that uses LC/MS/MS to provide greater sensitivity and specificity over other techniques. Lancaster Laboratories’ new method meets the Food and Drug Administration’s August 2009 guidance, entitled Pharmaceutical Components at Risk for Melamine Contamination, which identifies raw materials that are considered high risk for melamine contamination and recommends monitoring of these raw materials for the presence of melamine prior to release into production.