Mariah Ultramari | Universidade de São Paulo (original) (raw)

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Papers by Mariah Ultramari

Research paper thumbnail of Liquid Chromatographic Peak Purity Assessments in Forced Degradation Studies: An Industry Perspective

Deleted Journal, 2024

digital) is published monthly by MultiMedia Healthcare, LLC., 2 Commerce Drive Cranbury, NJ 08512... more digital) is published monthly by MultiMedia Healthcare, LLC., 2 Commerce Drive Cranbury, NJ 08512, and is distributed free of charge to users and specifiers of chromatographic equipment in the United States and Canada. LCGC is available on a paid subscription basis to nonqualified readers in the United States and its possessions at the rate of: 1 year (13 issues

Research paper thumbnail of Pharmaceutical Forced Degradation (Stress Testing) Endpoints: A Scientific Rationale and Industry Perspective

Journal of Pharmaceutical Sciences

Research paper thumbnail of Isolamento e caracterização de produtos de degradação do ativo farmacêutico cloridrato de doxorrubicina

Research paper thumbnail of Determinação de 'beta'-n-metilamino-L-alanina (L-BMAA) em amostras ambientais por ressonância magnética nuclear (RMN 'ANTPOT. 1' H)

Revista Brasileira de Toxicologia, 2009

Research paper thumbnail of Development of an analytical method by HPLC-PDA for determination of lopinavir and ritonavir degradation products

Brazilian Journal of Pharmaceutical Sciences, 2011

Research paper thumbnail of Determinação de microcistinas nas represas de abastecimento da grande São Paulo por cromatografia líquida acoplada à espectrometria de massas

Research paper thumbnail of H NMR determination of bN-methylamino-L-alanine ( L-BMAA ) in environmental and biological samples

A nuclear magnetic resonance (1H NMR) method for the determination of b-N-methylamino-L-alanine (... more A nuclear magnetic resonance (1H NMR) method for the determination of b-N-methylamino-L-alanine (L-BMAA) in environmental aqueous samples was developed and validated. L-BMAA is a neurotoxic modified amino acid that can be produced by cyanobacteria in aqueous environments. This toxin was extracted from samples by means of solid-phase extraction (SPE) and identified and quantified by 1H NMR without further derivatization steps. The lower limit of quantification (LLOQ) was 5 mg/mL. Good inter and intra-assay precision was also observed (relative standard deviation <8.5%) with the use of 4-nitro-DLphenylalanine as an internal standard (IS). This method of 1H NMR analysis is not time consuming and can be readily utilized to monitor L-BMAA and confirm its presence in environmental and biological samples. 2008 Elsevier Ltd. All rights reserved.

Research paper thumbnail of Characterization and in silico Mutagenic Assessment of a New Betahistine Degradation Impurity

Journal of the Brazilian Chemical Society, 2019

Currently, the pharmaceutical industry devotes great attention to drug degradation products becau... more Currently, the pharmaceutical industry devotes great attention to drug degradation products because these compounds can offer risks to patients. A previous degradation study of betahistine (N-α-methyl-2-pyridylethylamine) conducted under different stress conditions detected three main impurities named A, B and C. Degradation products were analyzed by high-resolution mass spectrometry in electrospray source and time of flight analyzer (ESI-TOF) and nuclear magnetic resonance (NMR). Impurity mutagenicity was evaluated by Derek Nexus and Sarah Nexus softwares. Liquid chromatography hyphenate with tandem mass spectrometry (LC-MS/MS) analysis of the betahistine forced degradation sample indicated the presence of a new impurity, which was named impurity C1. 2D NMR experiments allowed the complete structural characterization of the new entity. The active pharmaceutical ingredient and degradation impurities were classified as inactive in the in silico mutagenic studies. Systematic investigation of a forced degradation sample led to the characterization of a new betahistine impurity. The in silico mutagenicity study of the betahistine degradation impurities may be useful in the risk assessment of the drug products.

Research paper thumbnail of Desenvolvimento de método indicativo de estabilidade para o antineoplásico cloridrato de doxorrubicina e avaliação da toxicidade in vitro de seus principais produtos de degradação

Research paper thumbnail of Stability indicating method development for the antineoplastic drug doxorubicin and in vitro toxicity evaluation of its main degradation products

Em julho de 2008, a ANVISA publicou um informe técnico esclarecendo um item importante da RE nº 1... more Em julho de 2008, a ANVISA publicou um informe técnico esclarecendo um item importante da RE nº 1 (2005), que trata sobre os estudos de estabilidade de medicamentos. Este documento originou uma nova RDC de nº 58, publicada em dezembro de 2013, a qual estabelece limites para produtos de degradação em medicamentos. O objetivo do presente trabalho foi avaliar o comportamento do antineoplástico cloridrato de doxorrubicina frente a condições de decomposição (hidrólise ácida, básica, oxidação, temperatura e fotólise), a fim de se determinar suas principais vias de degradação e também elucidar as estruturas de seus principais produtos de degradação. Para isso foi desenvolvido e validado um método indicativo de estabilidade por HPLC-DAD-MS, o qual utiliza como fase estacionária uma coluna Luna C18(2) (150 mm x 3,0 mm, µm) com gradiente de fase móvel de tampão formiato de amônio 5 mmoles.L-1 pH 3 e metanol e fluxo de 0,3 mL.min-1. Ao longo do estudo foram encontrados diversos produtos de deg...

Research paper thumbnail of 1H NMR determination of β- N-methylamino- l -alanine ( l -BMAA) in environmental and biological samples

Toxicon, 2009

A nuclear magnetic resonance ( 1 H NMR) method for the determination of b-N-methylamino-L-alanine... more A nuclear magnetic resonance ( 1 H NMR) method for the determination of b-N-methylamino-L-alanine (L-BMAA) in environmental aqueous samples was developed and validated. L-BMAA is a neurotoxic modified amino acid that can be produced by cyanobacteria in aqueous environments. This toxin was extracted from samples by means of solid-phase extraction (SPE) and identified and quantified by 1 H NMR without further derivatization steps. The lower limit of quantification (LLOQ) was 5 mg/mL. Good inter and intra-assay precision was also observed (relative standard deviation <8.5%) with the use of 4-nitro-DLphenylalanine as an internal standard (IS). This method of 1 H NMR analysis is not time consuming and can be readily utilized to monitor L-BMAA and confirm its presence in environmental and biological samples.

Research paper thumbnail of Liquid Chromatographic Peak Purity Assessments in Forced Degradation Studies: An Industry Perspective

Deleted Journal, 2024

digital) is published monthly by MultiMedia Healthcare, LLC., 2 Commerce Drive Cranbury, NJ 08512... more digital) is published monthly by MultiMedia Healthcare, LLC., 2 Commerce Drive Cranbury, NJ 08512, and is distributed free of charge to users and specifiers of chromatographic equipment in the United States and Canada. LCGC is available on a paid subscription basis to nonqualified readers in the United States and its possessions at the rate of: 1 year (13 issues

Research paper thumbnail of Pharmaceutical Forced Degradation (Stress Testing) Endpoints: A Scientific Rationale and Industry Perspective

Journal of Pharmaceutical Sciences

Research paper thumbnail of Isolamento e caracterização de produtos de degradação do ativo farmacêutico cloridrato de doxorrubicina

Research paper thumbnail of Determinação de 'beta'-n-metilamino-L-alanina (L-BMAA) em amostras ambientais por ressonância magnética nuclear (RMN 'ANTPOT. 1' H)

Revista Brasileira de Toxicologia, 2009

Research paper thumbnail of Development of an analytical method by HPLC-PDA for determination of lopinavir and ritonavir degradation products

Brazilian Journal of Pharmaceutical Sciences, 2011

Research paper thumbnail of Determinação de microcistinas nas represas de abastecimento da grande São Paulo por cromatografia líquida acoplada à espectrometria de massas

Research paper thumbnail of H NMR determination of bN-methylamino-L-alanine ( L-BMAA ) in environmental and biological samples

A nuclear magnetic resonance (1H NMR) method for the determination of b-N-methylamino-L-alanine (... more A nuclear magnetic resonance (1H NMR) method for the determination of b-N-methylamino-L-alanine (L-BMAA) in environmental aqueous samples was developed and validated. L-BMAA is a neurotoxic modified amino acid that can be produced by cyanobacteria in aqueous environments. This toxin was extracted from samples by means of solid-phase extraction (SPE) and identified and quantified by 1H NMR without further derivatization steps. The lower limit of quantification (LLOQ) was 5 mg/mL. Good inter and intra-assay precision was also observed (relative standard deviation <8.5%) with the use of 4-nitro-DLphenylalanine as an internal standard (IS). This method of 1H NMR analysis is not time consuming and can be readily utilized to monitor L-BMAA and confirm its presence in environmental and biological samples. 2008 Elsevier Ltd. All rights reserved.

Research paper thumbnail of Characterization and in silico Mutagenic Assessment of a New Betahistine Degradation Impurity

Journal of the Brazilian Chemical Society, 2019

Currently, the pharmaceutical industry devotes great attention to drug degradation products becau... more Currently, the pharmaceutical industry devotes great attention to drug degradation products because these compounds can offer risks to patients. A previous degradation study of betahistine (N-α-methyl-2-pyridylethylamine) conducted under different stress conditions detected three main impurities named A, B and C. Degradation products were analyzed by high-resolution mass spectrometry in electrospray source and time of flight analyzer (ESI-TOF) and nuclear magnetic resonance (NMR). Impurity mutagenicity was evaluated by Derek Nexus and Sarah Nexus softwares. Liquid chromatography hyphenate with tandem mass spectrometry (LC-MS/MS) analysis of the betahistine forced degradation sample indicated the presence of a new impurity, which was named impurity C1. 2D NMR experiments allowed the complete structural characterization of the new entity. The active pharmaceutical ingredient and degradation impurities were classified as inactive in the in silico mutagenic studies. Systematic investigation of a forced degradation sample led to the characterization of a new betahistine impurity. The in silico mutagenicity study of the betahistine degradation impurities may be useful in the risk assessment of the drug products.

Research paper thumbnail of Desenvolvimento de método indicativo de estabilidade para o antineoplásico cloridrato de doxorrubicina e avaliação da toxicidade in vitro de seus principais produtos de degradação

Research paper thumbnail of Stability indicating method development for the antineoplastic drug doxorubicin and in vitro toxicity evaluation of its main degradation products

Em julho de 2008, a ANVISA publicou um informe técnico esclarecendo um item importante da RE nº 1... more Em julho de 2008, a ANVISA publicou um informe técnico esclarecendo um item importante da RE nº 1 (2005), que trata sobre os estudos de estabilidade de medicamentos. Este documento originou uma nova RDC de nº 58, publicada em dezembro de 2013, a qual estabelece limites para produtos de degradação em medicamentos. O objetivo do presente trabalho foi avaliar o comportamento do antineoplástico cloridrato de doxorrubicina frente a condições de decomposição (hidrólise ácida, básica, oxidação, temperatura e fotólise), a fim de se determinar suas principais vias de degradação e também elucidar as estruturas de seus principais produtos de degradação. Para isso foi desenvolvido e validado um método indicativo de estabilidade por HPLC-DAD-MS, o qual utiliza como fase estacionária uma coluna Luna C18(2) (150 mm x 3,0 mm, µm) com gradiente de fase móvel de tampão formiato de amônio 5 mmoles.L-1 pH 3 e metanol e fluxo de 0,3 mL.min-1. Ao longo do estudo foram encontrados diversos produtos de deg...

Research paper thumbnail of 1H NMR determination of β- N-methylamino- l -alanine ( l -BMAA) in environmental and biological samples

Toxicon, 2009

A nuclear magnetic resonance ( 1 H NMR) method for the determination of b-N-methylamino-L-alanine... more A nuclear magnetic resonance ( 1 H NMR) method for the determination of b-N-methylamino-L-alanine (L-BMAA) in environmental aqueous samples was developed and validated. L-BMAA is a neurotoxic modified amino acid that can be produced by cyanobacteria in aqueous environments. This toxin was extracted from samples by means of solid-phase extraction (SPE) and identified and quantified by 1 H NMR without further derivatization steps. The lower limit of quantification (LLOQ) was 5 mg/mL. Good inter and intra-assay precision was also observed (relative standard deviation <8.5%) with the use of 4-nitro-DLphenylalanine as an internal standard (IS). This method of 1 H NMR analysis is not time consuming and can be readily utilized to monitor L-BMAA and confirm its presence in environmental and biological samples.