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Pharmaceutical Development and Technology Volume 10, 2005 - Issue 2
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Research Article

Degradation of a Lyophilized Formulation of BMS-204352: Identification of Degradants and Role of Elastomeric Closures

Munir N. Nassar Biopharmaceutics Research and Development, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA
, Ph.D.,
Vishwas V. Nesarikar Biopharmaceutics Research and Development, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA
,
Ruben Lozano Analytical Research and Development, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA
,
Yande Huang Process Research and Development, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA
&
Venkatapuram Palaniswamy Process Research and Development, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA
Pages 227-232 | Received 08 Aug 2004, Accepted 26 Oct 2004, Published online: 07 Oct 2008

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Qiqing Zhong, Sarah Stowers, Nathaniel L. Segraves, Kenley K. Ngim, Ke Zhang, Tracy Bostick, Alan Deese & Nik P. Chetwyn. (2013) Degradation of a pharmaceutical in HPLC grade methanol containing trace level formaldehyde. Pharmaceutical Development and Technology 18:4, pages 877-882.
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Munir N. Nassar, Vishwas V. Nesarikar, Nona Khaselev & Ruben Lozano. (2006) Impurities in a Lyophilized Formulation of BMS-204352: Identification and Role of Sanitizing Agents. Pharmaceutical Development and Technology 11:2, pages 207-211.
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Héctor Santana, Luis Ariel Espinosa, Aniel Sánchez, Alain Bolaño Alvarez, Vladimir Besada & Luis Javier González. (2021) Mass spectrometric and kinetics characterization of modified species of Growth Hormone Releasing Hexapeptide generated under thermal stress in different pH and buffers. Journal of Pharmaceutical and Biomedical Analysis 194, pages 113776.
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Camille Fauchere, Markoulina Berger-Gryllaki & Farshid Sadeghipour. (2019) Investigation of Drug-Packaging Interactions with Mass Spectroscopy Detectors: A Meta-Synthesis of the Literature. Pharmaceutical Technology in Hospital Pharmacy 4:1, pages 3-14.
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Thomas Linz, Dominick Yeo, Qiuting Hong, Wesley Zmolek, Jesse McFarland, Robyn Barfield, William Haskins & David Rabuka. (2018) Systematic LC/MS/MS Investigations for the IND-Enabling Extended Characterization of Antibody–Drug Conjugate Modifications. Antibodies 7:4, pages 40.
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Roman Mathaes & Alexander Streubel. 2018. Challenges in Protein Product Development. Challenges in Protein Product Development 191 202 .
Nguyen Ngoc Bich, Nguyen Thi Hue Trang, Nguyen Duy Luan & Huynh Van Son. (2016) The Potential Use of Natural Rubber in Pharmaceutical Closures. Progress in Rubber, Plastics and Recycling Technology 32:2, pages 87-98.
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Min Li. 2012. Organic Chemistry of Drug Degradation. Organic Chemistry of Drug Degradation 150 164 .
Shayne Cox GadEmmanuel O. Akala. 2010. Pharmaceutical Sciences Encyclopedia. Pharmaceutical Sciences Encyclopedia.
Mark D. Argentine & Patrick J. Jansen. 2010. Pharmaceutical Stability Testing to Support Global Markets. Pharmaceutical Stability Testing to Support Global Markets 135 144 .
Dennis Jenke. 2009. Compatibility of Pharmaceutical Products and Contact Materials. Compatibility of Pharmaceutical Products and Contact Materials 229 247 .
Claudia Corredor, Frank P. Tomasella & Joel Young. (2009) Drug interactions with potential rubber closure extractables. Journal of Chromatography A 1216:1, pages 43-48.
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