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Drug Development and Industrial Pharmacy Volume 42, 2016 - Issue 4: Special Focus Issue: Ocular and Ophthalmic Drug Delivery Systems
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Non-themed Articles

Application of NIR chemometric methods for quantification of the crystalline fraction of warfarin sodium in drug product

Maxwell Korang-YeboahDivision of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
,
Sohail AkhtarDivision of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
,
Akhtar SiddiquiDivision of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
,
Ziyaur RahmanDivision of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
&
Mansoor A. KhanDivision of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USACorrespondence[email protected]
Pages 584-594 | Received 05 Mar 2015, Accepted 29 May 2015, Published online: 10 Jul 2015

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M. Razuc, A. Grafia, L. Gallo, M. V. Ramírez-Rigo & R. J. Romañach. (2019) Near-infrared spectroscopic applications in pharmaceutical particle technology. Drug Development and Industrial Pharmacy 45:10, pages 1565-1589.
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Articles from other publishers (15)

Jean P. Feng Báez, Mery Vet George De la Rosa, Bárbara B. Alvarado-Hernández, Rodolfo J. Romañach & Torsten Stelzer. (2023) Evaluation of a compact composite sensor array for concentration monitoring of solutions and suspensions via multivariate analysis. Journal of Pharmaceutical and Biomedical Analysis 233, pages 115451.
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Sathish Dharani, Khaldia Sediri, Phillip Cook, Rajendran Arunagiri, Mansoor A. Khan & Ziyaur Rahman. (2021) Preparation and Characterization of Stable Amorphous Glassy Solution of BCS II and IV Drugs. AAPS PharmSciTech 23:1.
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Harsh S. Shah, Kaushalendra Chaturvedi, Rutesh H. Dave & Kenneth R. Morris. (2021) Molecular Insights into Warfarin Sodium 2-Propanol Solvate Solid Form Changes and Disproportionation Using a Low Volume Two-Stage Dissolution Approach. Molecular Pharmaceutics 18:4, pages 1779-1791.
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Harsh S. Shah, Kaushalendra Chaturvedi, Rutesh H. Dave, Simon Bates, Rahul V. Haware & Kenneth R. Morris. (2020) New Insights on Warfarin Sodium 2-Propanol Solvate Solid-State Changes Using a Multivariate Approach. Crystal Growth & Design 20:11, pages 7328-7340.
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Nuno F. da Costa, Ana I. Fernandes & João F. Pinto. (2020) Measurement of the amorphous fraction of olanzapine incorporated in a co-amorphous formulation. International Journal of Pharmaceutics 588, pages 119716.
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Diaa Shakleya, Ziyaur Rahman & Patrick J. Faustino. (2019) Development and validation of an ultra‐high‐performance liquid chromatography–tandem mass spectrometry method to determine the bioavailability of warfarin and its major metabolite 7‐hydroxy warfarin in rats dosed with oral formulations containing different polymorphic forms. Biomedical Chromatography 33:12.
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Julia A. Griffen, Andrew W. Owen & Pavel Matousek. (2018) Quantifying low levels (<0.5% w/w) of warfarin sodium salts in oral solid dose forms using Transmission Raman spectroscopy. Journal of Pharmaceutical and Biomedical Analysis 155, pages 276-283.
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Sathish Dharani, Ziyaur Rahman, Sogra F. Barakh Ali, Hamideh Afrooz & Mansoor A. Khan. (2018) Quantitative estimation of phenytoin sodium disproportionation in the formulations using vibration spectroscopies and multivariate methodologies. International Journal of Pharmaceutics 539:1-2, pages 65-74.
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Natalia L. Calvo, Rubén M. Maggio & Teodoro S. Kaufman. (2018) Chemometrics-assisted solid-state characterization of pharmaceutically relevant materials. Polymorphic substances. Journal of Pharmaceutical and Biomedical Analysis 147, pages 518-537.
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Rahul B. Chavan, Nallamothu Bhargavi, Anurag Lodagekar & Nalini R. Shastri. (2017) Near infra red spectroscopy: a tool for solid state characterization. Drug Discovery Today 22:12, pages 1835-1843.
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Xiao-Meng Chong, Wen-Bo Zou, Shang-Chen Yao & Chang-Qin Hu. (2016) Rapid Analysis of the Quality of Amoxicillin and Clavulanate Potassium Tablets Using Diffuse Reflectance Near-Infrared Spectroscopy. AAPS PharmSciTech 18:4, pages 1311-1317.
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Adam C. Fisher, Sau L. Lee, Daniel P. Harris, Lucinda Buhse, Steven Kozlowski, Lawrence Yu, Michael Kopcha & Janet Woodcock. (2016) Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality. International Journal of Pharmaceutics 515:1-2, pages 390-402.
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Maxwell Korang-Yeboah, Ziyaur Rahman, Dhaval Shah, Adil Mohammad, Suyang Wu, Akhtar Siddiqui & Mansoor A. Khan. (2016) Impact of formulation and process variables on solid-state stability of theophylline in controlled release formulations. International Journal of Pharmaceutics 499:1-2, pages 20-28.
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Maxwell Korang-Yeboah, Ziyaur Rahman, Dhaval A. Shah & Mansoor A. Khan. (2016) Spectroscopic-Based Chemometric Models for Quantifying Low Levels of Solid-State Transitions in Extended Release Theophylline Formulations. Journal of Pharmaceutical Sciences 105:1, pages 97-105.
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Ziyaur Rahman, Maxwell Korang-Yeboah, Akhtar Siddiqui, Adil Mohammad & Mansoor A. Khan. (2015) Understanding effect of formulation and manufacturing variables on the critical quality attributes of warfarin sodium product. International Journal of Pharmaceutics 495:1, pages 19-30.
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