Testes compendiais e orientação regulatória
Os patrocinadores e requerentes de medicamentos são obrigados a propor especificações (ou seja, atributos, procedimentos analíticos e critérios de aceitação) para os excipientes, insumos farmacêuticos ativos e medicamentos em seus pedidos.
Estas especificações devem aderir aos padrões de qualidade dispostos na Farmacopeia/Formulário Nacional dos Estados Unidos (USP/NF), na Farmacopeia Britânica (BP), na Farmacopeia Europeia (EP) ou na Farmacopeia Japonesa (JP).
Os testes farmacopeicos compendiais são protocolos padronizados para muitas matérias-primas e produtos finais farmacêuticos. Os testes e a conformidade com essas normas detalhadas nos métodos compendiais são requisitos básicos para a fabricação, liberação e distribuição de ingredientes farmacêuticos e medicamentos em nível global.
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Artigos técnicos relacionados
- Compendial methods from the USP (United States Pharmacopeia) are widely used in pharmaceutical drug product and raw materials testing. However, not all methods in the USP use modern technologies. In chromatographic methods, it is not uncommon that older brands of columns are specified. Therefore, the USP methods are under continuous revision to improve existing procedures or to allow the user to obtain better results.
- Determination of the progestin medication, Drospirenone, using Purospher® STAR RP-18e Hibar® HPLC column and meeting the system suitability criteria as described in the USP monograph.
- The titer determination or standardization of a titration solution is essential for accurate and reliable titration results.
- Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.
- This application note describes the LC-MS-based quantitative analysis of known nitrosamine impurities following procedures 1 and 3 as given in USP general chapter <1469>.
- Technical article on Selecting the Right Water Purification System
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Protocolos relacionados
- This paper illustrates the setting up of a Lopinavir assay following European pharmacopoeia guidelines (10.2), and using a shorter column packed with smaller particles. The described assay saves valuable time and improves separation efficiency, which typically translates to better method performance.
- Aripiprazole is an atypical antipsychotic and a partial dopamine agonist. It is primarily used in the treatment of schizophrenia, bipolar disorder, major depressive disorder, tic disorders, and irritability associated with autism. Aripiprazole was first approved by the U.S. Food and DrugAdministration in November 2002 for schizophrenia and by the European Medicines Agency in June 2004 for acute manic and mixed episodes associated with bipolar disorder.
- Under applied conditions, system suitability criteria are met, and the Chloroquine Phosphate HPLC Assay and Impurity Profiling Methods demonstrate good resolution/selectivity, reproducibility, and sensitivity.
- Folic acid or folate is classified as a B vitamin (B9). Folic acid is synthetically produced, and used in fortified foods and supplements. Folate is converted by humans to dihydrofolate (dihydrofolic acid), tetrahydrofolate (tetrahydrofolic acid), and other derivatives, which have various biological activities.
- Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension.
- Following GB method for Vitamin A and Vitamin E as it is written with a 250 x 4.6 mm Ascentis® Express C30 column gives baseline resolution between the critical pair (gamma-, and beta-tocopherol; peaks 3 and 4).
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Destaques
Do desenvolvimento à liberação do medicamento, este PDF interativo descreve diversos filtros e reagentes confiáveis e consistentes para o protocolo de teste de dissolução
Esta apresentação oferece uma visão geral de alto nível dos valores específicos dos padrões farmacopeicos.
Aprenda estratégias para melhorar a produtividade e reduzir os custos em suas análises farmacêuticas com a adaptação do método U/HPLC.
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