Articles with "forced degradation" as a keyword



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Forced degradation study with a developed and validated RP-HPLC method for determination of cefpodoxime proxetil in the bulk and finished pharmaceutical products

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Published in 2019 at "Journal of the Iranian Chemical Society"

DOI: 10.1007/s13738-019-01630-5

Abstract: The present study aimed to develop an HPLC method of Cfp analysis which enjoyed highly linearity, repeatability, robustness, ruggedness, selectivity, rapidly, and economic to use. The chromatographic method uses a column Inertsil ODS-3 (250 mm × 4.6 mm × 5 µm). The… read more here.

Keywords: forced degradation; bulk; method; degradation study ... See more keywords
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Development of stabilized fuzapladib solution for injection: forced degradation study and pharmacokinetic evaluation

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Published in 2022 at "Pharmaceutical Development and Technology"

DOI: 10.1080/10837450.2022.2089165

Abstract: Abstract The aim of the present study was to develop and evaluate stabilized injection solutions of fuzapladib sodium hydrate using antioxidants as the stabilizers. To estimate the possible degradation factors and pathways of fuzapladib, forced… read more here.

Keywords: injection; fuzapladib solution; forced degradation; degradation ... See more keywords
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Using bispecific antibodies in forced degradation studies to analyze the structure–function relationships of symmetrically and asymmetrically modified antibodies

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Published in 2019 at "mAbs"

DOI: 10.1080/19420862.2019.1618675

Abstract: ABSTRACT Forced degradation experiments of monoclonal antibodies (mAbs) aid in the identification of critical quality attributes (CQAs) by studying the impact of post-translational modifications (PTMs), such as oxidation, deamidation, glycation, and isomerization, on biological functions.… read more here.

Keywords: function; structure function; symmetrically asymmetrically; forced degradation ... See more keywords
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Development of a stability-indicating assay method by HPLC-DAD and MS characterization of forced degradation products of ravuconazole.

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Published in 2021 at "Journal of chromatographic science"

DOI: 10.1093/chromsci/bmab064

Abstract: Ravuconazole (RAV) is a triazole antifungal with broad spectrum and a novel alternative in the treatment of systemic fungal infections. A stability-indicating method by high-performance liquid chromatography-diode array detection was developed and fully validated to… read more here.

Keywords: degradation; forced degradation; degradation products; stability indicating ... See more keywords
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Mini Review on Forced Degradation Studies on Anti-Epileptic Drugs and Beyond.

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Published in 2022 at "Journal of chromatographic science"

DOI: 10.1093/chromsci/bmac070

Abstract: In this review on the forced degradation studies on anti-epileptic drugs and the development of validated stability-indicating assay methods for drug substances and products at a condition more severe than accelerated condition (i.e. 40 ± 2°C, 75 ± 5%… read more here.

Keywords: epileptic drugs; studies anti; forced degradation; degradation ... See more keywords
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Forced degradation studies of elagolix sodium with the implementation of high resolution LC-UV-PDA-MSn (n = 1,2,3…) and NMR structural elucidation.

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Published in 2022 at "Journal of pharmaceutical and biomedical analysis"

DOI: 10.2139/ssrn.4252205

Abstract: Elagolix sodium (ELS) is a marketed product using to release moderate to severe endometriosis-associated pain. It contains functional groups such as carboxyl group, secondary amino group, 2,4-dioxo pyrimidinyl and several benzyl or benzyl-like position hydrogen… read more here.

Keywords: hydrogen; elagolix sodium; group; forced degradation ... See more keywords
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Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination

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Published in 2019 at "Acta Pharmaceutica"

DOI: 10.2478/acph-2019-0025

Abstract: Abstract An ultra-high performance liquid chromatography method for simultaneous determination of tacrolimus impurities in pharmaceutical dosage forms has been developed. Appropriate chromatographic separation was achieved on a BEH C18 column using gradient elution with a… read more here.

Keywords: degradation; forced degradation; determination; method ... See more keywords
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Forced Degradation Studies and Development and Validation of HPLC-UV Method for the Analysis of Velpatasvir Copovidone Solid Dispersion

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Published in 2022 at "Antibiotics"

DOI: 10.3390/antibiotics11070897

Abstract: Analytical methods for the drug substance and degradation products (DPs) are validated by performing forced degradation studies. Forced degradation studies of Velpatasvir (VEL) drug substance and Velpatasvir copovidone solid dispersion (VEL-CSD) were performed under the… read more here.

Keywords: velpatasvir copovidone; forced degradation; method; vel ... See more keywords
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Development and Validation of Stability Indicating Method for Estimation of Buparvaquone by Forced Degradation Studies

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Published in 2020 at "Indian Journal of Pharmaceutical Education and Research"

DOI: 10.5530/ijper.54.3.131

Abstract: Aim: A lucid, rapid and precise stability-indicating method was developed by using HPLC for the estimation of Buparvaquone in bulk as well as pharmaceutical dosage form by forced degradation studies. Materials and Methods: Princeton C18… read more here.

Keywords: forced degradation; indicating method; stability indicating; estimation buparvaquone ... See more keywords
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Stability Indicating Forced Degradation Studies

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Published in 2019 at "Research Journal of Pharmacy and Technology"

DOI: 10.5958/0974-360x.2019.00078.7

Abstract: Forced degradation study (FD) studies (stress testing) are an intrinsic part of pharmaceutical product development. It is procedure whereby the natural degradation rate of a product or material is increased by the application of additional… read more here.

Keywords: development; stability indicating; degradation study; forced degradation ... See more keywords