Establishing acceptable limits
Limits: Practical, achievable and verifiable
Rationale: Logical, based on knowledge of materials
Each situation assessed individually
Principal reactant and other chemical variations
Screening (thin-layer chromatography) in addition to chemical analyses where necessary
11. Establishing acceptable limits
Note: uniform distribution of contaminants is not guaranteed.
11.1 The acceptance criteria established for contaminant levels in the sample should be practical, achievable and verifiable. The rationale for the residue limits established should be logical, and based on the knowledge of the materials involved.
11.2 Each situation should be assessed individually. The manner in which limits are established should be carefully considered. In establishing residual limits it may not be adequate to focus only on the principal reactant, because other chemical variations may be more difficult to remove.
11.3 Where necessary, screening using thin-layer chromatography should be performed in addition to chemical analyses.
11.4 There should be no residue from the previous product, from reaction by-products and degradants, or from the cleaning process itself (e.g. detergents or solvents).