For many industries working either at the development, production or operational level, there is increasing pressure to identify, characterise, quantify and monitor impurities. Potential sources of such impurities include;

• Raw materials
• Residual solvents or other chemicals used during the manufacturing process
• Degradants of a drug substance and its excipents
• Extractables and leachables from packaging, closed container systems etc.

Many QC methods use established methodologies and standard analytical techniques on already well characterised raw materials or products. In contrast early stage investigative work, processes subject to a material change etc. will typically require more definitive information.

The analytical techniques of GC-MS and LC-MS possess the capability to separate and then provide important structural information on any unknown. When combined with the mass spectrometer’s inherent high sensitivity and specificity, it means that such hyphenated instrument types are widely regarded as being capable of generating the most defensible data.

Following chromatographic separation the resultant mass spectrum of any unknown may be searched and compared against established libraries or user-contributed databases to facilitate identification.

Alternatively, for characterisation first principles de novo mass spectral interpretation in conjunction with a base structure may elicit a putative structure, with further corroboration provided by accurate mass determination and empirical formulae proposals for the intact unknown precursor and its resultant product ions.

Through the experience and expertise provided by our scientific staff, in combination with the range of single and tandem mass spectrometers possessed by the laboratory, we are widely used to assist clients in the identification and characterisation of product or process related impurities or degradants.

If you have a need to undertake either the identification or characterisation of unknowns in your sample sets then contact us - absolutely free and with no obligation!