During the lifetime of a cocaine batch from production end to consumption, several alterations may occur, leading to possible changes in the original impurity profile. Such profile changes may eventually result in erroneous forensic evaluations. In the present study, the stability of both the alkaloid and the residual solvent impurity profiles of cocaine were evaluated over a period of 12 months under different storage conditions (temperature, purity and weight) using GC-MS and HS-GC-MS, respectively. The sample purity (p<0.001), time of storage (p<0.001) and storage temperature at 37°C (p<0.01) significantly influenced the alkaloid impurity profile. The most significant change was observed in low purity samples stored at 37°C. In contrast, no changes were observed in the residual solvent profile at all storage conditions for the entire 12-month study period. This finding indicates that the residual solvent profile may be more applicable than the corresponding alkaloid profile when cocaine seizures subjected to different storage conditions are compared. Our results clearly demonstrate that cocaine alkaloid profiles change over time and are most susceptible to sample purity and storage temperature. As a consequence, storage conditions and purity should be taken into account when cocaine comparison is conducted in criminal cases.
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http://dx.doi.org/10.1016/j.forsciint.2016.03.012 | DOI Listing |
Nat Commun
December 2024
Department of Biomedical Engineering, Pennsylvania State University, University Park, PA, USA.
Over 80% of biologic drugs, and 90% of vaccines, require temperature-controlled conditions throughout the supply chain to minimize thermal inactivation and contamination. This cold chain is costly, requires stringent oversight, and is impractical in remote environments. Here, we report chemical dispersants that non-covalently solvate proteins within fluorous liquids to alter their thermodynamic equilibrium and reduce conformational flexibility.
View Article and Find Full Text PDFAnal Chem
December 2024
Janssen Pharmaceutica N.V., Turnhoutseweg 30, 2340 Beerse, Belgium.
Oligonucleotides are currently one of the most rapidly advancing classes of therapeutic modalities. Understanding critical quality attributes, such as the impurity profile, stability, potential metabolites, and sequence conformity, is the key to their ultimate success. To obtain the information presented above, liquid chromatography-mass spectrometry (LC-MS) is often employed.
View Article and Find Full Text PDFACS Meas Sci Au
December 2024
Synthetic Molecule Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, California 94080, United States.
Small molecules and antibodies have dominated the pharmaceutical landscape for decades. However, limitations associated with therapeutic targets deemed "undruggable" and progress in biology and chemistry have led to the blossoming of drug modalities and therapeutic approaches. In 2023, a high number of 9 oligonucleotide and peptide products were approved by the Food and Drug Administration (FDA), accounting for 16% of all drugs approved.
View Article and Find Full Text PDFMol Ther Methods Clin Dev
December 2024
University of Delaware, Department of Chemical and Biomolecular Engineering, Newark, DE 19713, USA.
To better understand host cell protein (HCP) retention in adeno-associated virus (AAV) downstream processes, sequential window acquisition of all theoretical fragment ion mass spectra (SWATH-MS) was used to quantitatively profile residual HCPs for four AAV serotypes (AAV2, -5, -8, and -9) produced with HEK293 cells and purified using POROS CaptureSelect AAVX affinity chromatography. A broad range of residual HCPs were detected in affinity eluates after purification ( = 2,746), and HCP profiles showed universally present species ( = 1,117) and species unique to one or more AAV serotype. SWATH-MS revealed that HCP persistence was dominated by high-abundance conserved species (HACS), which appeared across all serotype conditions studied.
View Article and Find Full Text PDFJ AOAC Int
December 2024
J-Star Research, Inc. A Porton Company 6 Cedarbrook Drive, Cranbury Township, NJ 08512, USA.
Background: Moxidectin is an active pharmaceutical ingredient (API) extensively used in various drug products within the pharmaceutical and animal health sectors. Despite its widespread use, the analytical methods prescribed by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP, Ph. Eur.
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