Trace Organic Analysis

September 5, 2014

The identification and quantification of residual solvents (RS) and organic volatile impurities (OVI) in pharmaceutical and otherproducts. Labofine assures clients that if organic volatile impurities and residual solvents have been reduced to the acceptable level in manufacture of drug substance, excipients and drug products.

 

  • Methods utilised include pharmacopeia methods (e.g. USP <467>) but methods can also be tailored to our client's specific needs.

 

  • Residual Solvents Screen by GCMS, GC-μECD with head space

    • Acrylamide by LC or Isotope-Dilution GCMS

    • Alcohols by GC or GCMS

    • Aldehydes and Ketones by LC, GC, or GCMS

    • Ethylene Chlorohydrin and Ethylene Glycol_ by GC