STUDY DESIGN
Linearity
5  solutions (in the appropriate range of concentration) from 5 different weighings of technical material reference item
Progressive dilutions, for each of the 5 solutions, until reaching the appropriate dilution factors
Precision
5  solutions (as 5 independent weighings of formulated product)
Progressive dilutions, for each of the 5 solutions, until reaching the appropriate dilution factors
Interferences check
Blank formulation: 2 samples
Study includes GLP management and reporting

REFERENCES AND GUIDELINES
SANCO/3030/99 rev. 4 (11/07/2000) – Technical Material and Preparations: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414.