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Armstrong, Daniel W.; Bergum, James; Brescia, Beth Ann; Bryan, Peter; Cecil, Todd L.; Chen, Ping; Fung, Eliza N.; Gray, Vivian A.; He, B. Brian; Little, L E; Lloyd, David K.; McArdle, James V.; Moyer, Kurt L.; Mueller, Bradford J.; Padivitage, Nilusha; Parente, Ernest; Phelps, Robyn L.; Riley, Shelley R. Rabel; Riley, Christopher M.; Rosanske, Thomas W.; Scull, James; Selinger, Krzysztof; Sheinin, Eric B.; Smith, Pamela A.; Smuts, Jonathan; Tishmack, Patrick A.

doi:10.1016/b978-0-08-098350-9.01002-x

Specification of Drug Substances and Products 2013

DOI: 10.1016/b978-0-08-098350-9.01002-x

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Daniel W. Armstrong¹,

James Bergum²,

Beth Ann Brescia³

et al.

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2022

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“…313 K in vacuo for ibuprofen, leaving small residual solvent concentrations adsorbed in the silica material. While these solvents have no therapeutic effect, they could be toxic and therefore should be avoided in the final product. ,,,− The European Pharmacopoeia limits the concentration of residual solvents in pharmaceuticals, considering the guidelines compiled by the International Conference on Harmonization in the ICH guideline Q3C (EMA/CHMP/ICH/82260/2006). Tolerated concentrations of residual dichloromethane (DCM) and methanol (MeOH) are for example limited to 600 and 3000 ppm, respectively. ,,, …”

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Absolute Quantification of Residual Solvent in Mesoporous Silica Drug Formulations Using Magic-Angle Spinning NMR Spectroscopy

et al. 2022

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Porous silica is used as a drug delivery agent to improve the bioavailability of sparsely soluble compounds. In this approach, the active pharmaceutical ingredient (API) is commonly loaded into the porous silica by incipient wetness impregnation using organic solvents. Subsequent solvent elimination is critical as the residual solvent concentration cannot exceed threshold values set by health and safety regulations (e.g., EMA/CHMP/ICH/82260/2006). For dichloromethane and methanol, for example, residual concentrations must be below 600 and 3000 ppm, respectively. Today, EU and USA Pharmacopoeias recommend tedious procedures for residual solvent quantification, requiring extraction of the solvent and subsequent quantification using capillary gas chromatography with static headspace sampling (sHS-GC). This work presents a new method based on the combination of standard addition and absolute quantification using magic-angle spinning nuclear magnetic resonance spectroscopy (MAS qNMR). The methodology was originally developed for absolute quantification of water in zeolites and has now been validated for quantification of residual solvent in drug formations using mesoporous silica loaded with ibuprofen dissolved in DCM and MeOH as test samples. Interestingly, formulations prepared using as-received or predried mesoporous silica contained 5465 versus 484.9 ppm DCM, respectively. This implies that the initial water content of the silica carrier can impact the residual solvent concentration in drug-loaded materials. This observation could provide new options to minimize the occurrence of these undesired solvents in the final formulation.

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Absolute Quantification of Residual Solvent in Mesoporous Silica Drug Formulations Using Magic-Angle Spinning NMR Spectroscopy

et al. 2022

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Cited by 1 publication

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Absolute Quantification of Residual Solvent in Mesoporous Silica Drug Formulations Using Magic-Angle Spinning NMR Spectroscopy

Absolute Quantification of Residual Solvent in Mesoporous Silica Drug Formulations Using Magic-Angle Spinning NMR Spectroscopy

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