Method validation according to pharmacy standards

Identifier:  TFG:2630

Handle: https://hdl.handle.net/20.500.11797/TFG2630

Authors:  Ventura Argelaga, Anna

Abstract:
The main objective of this project is the AC-TH501 method validation, an analytical method which the presence of free ATBS is determinated in personal care products, made in the AMPS plant of the company Clariant Ibérica S.A. The validation was done considering that it is a non-normalized established method, so different parameters were studied. These are the linearity, the limits of detection and quantification, accuracy and robustness. Each of this parameters was validated with statistical tests and studies, some of which were complemented by visual evidence, such as robustness. The acceptance criteria used in each case was established by the company's quality supervisor, knowing which was the main purpose of the method. The AC-TH501 method, looking at the results obtained during the validation process and the established acceptance criteria, is considered valid to be used in the analysis of these same products but for pharmacological purposes, as excipients.