Analytical method validation for determination of the active ingredient in technical materials

STUDY DESIGN
Linearity
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.

 

 

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Scientific Contact

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

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