Lc/Ms:an Essential Tool in Drug Development

Baluguri, Pavan Kumar; Nama, Srikanth; Chandu, Babu Rao; Sakala, Bhargavi

doi:10.7439/ijapa.v1i2.9

Cited by 2 publications

(2 citation statements)

References 15 publications

(18 reference statements)

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“…Returning to the example of morphologically directed imaging, these systems involve considerable investment but can deliver significant value over the long term. Being able to measure not just size and shape but also the distribution of different chemical species within a dispersed sample, such as a disintegrated tablet, can be invaluable when trying to really understand how the process works and how to optimize it 16 .…”

Section: • Process Relevancementioning

confidence: 99%

Optimizing Tabletting Processes with Quality by Design: An Overview

Nwoko¹

2010

IJDDT

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The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. A process is well understood when all critical sources of variability are identified and explained, variability is managed by the process, and product quality attributes can be accurately and reliably predicted over the design space. Quality by Design (QbD) is a systematic approach to development of products and processes that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science, statistical methods and quality risk management. In an attempt to curb rising development costs and regulatory barriers to innovation and creativity, the FDA and ICH have recently started promoting QbD in the pharmaceutical industry [1, 3, 7,]. QbD is partially based on the application of multivariate statistical methods [2, 4, 6] and a statistical Design of Experiments strategy [4, 5, 6] to the development of both analytical methods and pharmaceutical formulations. The talk will review the basics of QbD with case studies from the pharmaceutical industry

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Section: • Process Relevancementioning

confidence: 99%

Optimizing Tabletting Processes with Quality by Design: An Overview

Nwoko¹

2010

IJDDT

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“…Among analytical instrumental techniques used in the analysis of degradation products and impurity profiling during the period 2013-2017, LC-MS appears to be the most common technique. 5,6 The latter technique is based on atmospheric pressure ionization that has no uniform response, suffers from matrix effects, and relies on the proton affinity of the analyzed analyte. 7 Also, the identification of the compounds is less reliable than when in-vacuum electron ionization (EI) gas chromatography-mass spectrometry (GC-MS) is used.…”

Section: Introductionmentioning

confidence: 99%

Analysis of impurities in pharmaceuticals by LC‐MS with cold electron ionization

2020

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Pharmaceuticals require careful and precise determination of their impurities that might harm the user upon consumption. Although today, the most common technique for impurities identification is liquid chromatography-mass spectrometry (LC-MS/MS), it has several downsides due to the nature of the ionization method. Also, the analyses in many cases are targeted thus despite being present, some of the compounds will not be revealed. In this paper, we propose and show a new method for untargeted analysis and identification of impurities in active pharmaceutical ingredients (APIs). The instrument used for these analyses is a novel electron ionization (EI) LC-MS with supersonic molecular beams (SMB). The EI-LC-MS-SMB was implemented for analyses of several drug samples spiked with an impurity. The instrument provides EI mass spectra with enhanced molecular ions, named Cold EI, which increases the identification probabilities when the compound is identified with the aid of an EI library like National Institute of Standards and Technology (NIST). We analyzed ibuprofen and its impurities, and both the API and the expected impurity were identified with names and structures by the NIST library. Moreover, other unexpected impurities were found and identified proving the ability of the EI-LC-MS-SMB system for truly untargeted analysis. The results show a broad dynamic range of four orders of magnitude at the same run with a signal-to-noise ratio of over 10 000 for the API and almost uniform response.

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Lc/Ms:an Essential Tool in Drug Development

Cited by 2 publications

References 15 publications

Optimizing Tabletting Processes with Quality by Design: An Overview

Optimizing Tabletting Processes with Quality by Design: An Overview

Analysis of impurities in pharmaceuticals by LC‐MS with cold electron ionization

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