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Adoption of new pharmacopeia chapters (USP and EP) for packaging materials
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Advisor(s)
Abstract(s)
A escolha inadequada do material de embalagem, particularmente na indústria farmacêutica,
pode comprometer a qualidade e segurança de um produto.
A presente tese de mestrado investigou a adoção de novos métodos de análise de materiais
de embalagem de Polietileno de Baixa Densidade (LDPE) propostos pela revisão da
Farmacopeia dos Estados Unidos (USP) e Farmacopeia Europeia (EP).
Diante da iminente revisão das farmacopeias que passará a ser efetiva em 2025, este estágio
teve como principal objetivo criar e aprovar novos métodos de análise de materiais de
embalagem, assegurando a conformidade com os parâmetros atualizados, com base nos
métodos disponibilizados pelas mesmas nos capítulos <661.1> e <661.2> da USP e 3.1 da
EP.
Os métodos de análise elaborados incluem a identificação por ATR-IR, a espectroscopia UV-
Vis, o Total Organic Carbon (TOC), a Appearance of Solution, a Acidity and Alkalinity e o teste
de Reducing Substances.
Métodos como a identificação por ATR-IR, Appearance of Solution e Acidity and Alkalinity são
considerados de rotina nos laboratórios da Hovione, portanto, não foram considerados para
execução de trabalho laboratorial no âmbito da verificação compendial. A espectroscopia UV-
Vis, TOC e o teste de Reducing Substances foram considerados e, para isso, foi elaborado o
protocolo de verificação compendial. Futuramente, estes métodos serão testados em
laboratório através de uma verificação compendial, aprovados e implementados como
métodos internos. Assim, ficará completa a sua efetivação de acordo com as atualizações das
farmacopeias seguidas pela Hovione.
Em resumo, este trabalho destaca a importância da adoção métodos de análise de materiais
de embalagem, mais especificamente de LDPE, de forma a assegurar a eficácia e qualidade
de produtos farmacêuticos.
The inappropriate choice of packaging material, particularly in the pharmaceutical industry, can compromise the quality and safety of a product. This master's thesis investigated the adoption of the new methods for analyzing Low Density Polyethylene (LDPE) packaging materials proposed by the revision of the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP). In view of the imminent revision of the pharmacopoeias that will become effective in 2025, the main objective of this internship was to create and approve new methods for analyzing packaging materials, ensuring compliance with the updated parameters, based on the methods provided by the pharmacopeias in chapters <661.1> and <661.2> of the USP and 3.1 of the EP. The analysis methods developed include ATR-IR identification, UV-Vis spectroscopy, TOC, Appearance of Solution, Acidity and Alkalinity and the Reducing Substances tests. Methods such as ATR-IR identification, Appearance of Solution and Acidity and Alkalinity are considered routine in Hovione's laboratories, so they were not considered for the laboratorial work in the scope of the compendial verification. UV-Vis spectroscopy, TOC and the Reducing Substances tests were considered and a compendial verification protocol was prepared. In the future, these methods will be tested in the laboratory under the compendial verification scope, approved and implemented as internal Hovione methods. This procedures will complete their implementation in accordance with the updated pharmacopoeias followed by Hovione. In summary, this work highlights the importance of the adoption of methods to analyze packaging materials, specifically LDPE, in order to ensure the efficacy and quality of pharmaceutical products.
The inappropriate choice of packaging material, particularly in the pharmaceutical industry, can compromise the quality and safety of a product. This master's thesis investigated the adoption of the new methods for analyzing Low Density Polyethylene (LDPE) packaging materials proposed by the revision of the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP). In view of the imminent revision of the pharmacopoeias that will become effective in 2025, the main objective of this internship was to create and approve new methods for analyzing packaging materials, ensuring compliance with the updated parameters, based on the methods provided by the pharmacopeias in chapters <661.1> and <661.2> of the USP and 3.1 of the EP. The analysis methods developed include ATR-IR identification, UV-Vis spectroscopy, TOC, Appearance of Solution, Acidity and Alkalinity and the Reducing Substances tests. Methods such as ATR-IR identification, Appearance of Solution and Acidity and Alkalinity are considered routine in Hovione's laboratories, so they were not considered for the laboratorial work in the scope of the compendial verification. UV-Vis spectroscopy, TOC and the Reducing Substances tests were considered and a compendial verification protocol was prepared. In the future, these methods will be tested in the laboratory under the compendial verification scope, approved and implemented as internal Hovione methods. This procedures will complete their implementation in accordance with the updated pharmacopoeias followed by Hovione. In summary, this work highlights the importance of the adoption of methods to analyze packaging materials, specifically LDPE, in order to ensure the efficacy and quality of pharmaceutical products.
Description
Keywords
Embalagem LDPE Método Farmacopeia Protocolo Packaging Method Pharmacopoeia Protocol