Pharmalytica Services is capable of providing the testing needed to meet the requirements of the new USP <467> procedure for Residual Solvents.

In summary, the analytical approach described in the Chapter has been updated for the use of headspace GC. A sample is first screened for all of the Class 1 and Class 2 solvents that are amenable to the method (Procedure A). If no peaks are detected then, the sample meets the specification. If any peaks corresponding to a solvent are detected, the sample is analyzed again using a different type of GC column (Procedure B). If no peak corresponding to the solvent tentatively identified in Procedure A is detected in Procedure B then, the sample meets the specification. However, if the presence of the solvent is confirmed by Procedure B, the sample is analyzed again in order to quantify the amount of solvent present (Procedure C). This is accomplished using the conditions from either Procedure A or Procedure B, whichever provides superior performance.

Request a quotation for USP <467> Testing
info@pharmalytica.com