Validation of the analytical method in the formulated product

STUDY DESIGN
Validation of the analytical method in the formulated product
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
Accuracy or Interference check
2 Fortification levels on the blank formulation: High and Low
Low level: 1 solution of blank sample added with known amount of technical material reference item
High level: 1 solution of blank sample added with known amount of technical material reference item Progressive dilutions, for each solution, until reaching the appropriate dilution factors
or
Interferences check
Blank formulation: 2 samples

Validation of the analytical method in the aqueous solutions
Linearity
5 solutions in Standard water (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 Standard water (as 5 independent weighings of formulated product)
Progressive dilutions, for each of the 5 solutions, until reaching the appropriate dilution factors
Accuracy or Interference check
2 Fortification levels on the blank formulation: High and Low
Low level: 1 solution in Standard water of blank sample added with known amount of technical material reference item
High level: 1 solution in Standard water of blank sample added with known amount of technical material reference item Progressive dilutions, for each solution, until reaching the appropriate dilution factors
or
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.

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Scientific Contact

Simona Coranelli
E-mail: scoranelli@biotecnologiebt.it
Phone: +39 075 895 0045 - Ext. 264

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E-mail: marketing@biotecnologiebt.it