Impurity Profiling
Impurity Profiling - Related Videos
09:14
Glovebox and Impurity Sensors
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2023
Source: Tamara M. Powers, Department of Chemistry, Texas A&M University The glovebox provides a straightforward means to handle air- and moisture-sensitive solids and liquids. The glovebox is what it sounds like: a box with gloves attached to one or more sides, which allows the user to perform manipulations within the glovebox under an inert atmosphere. For manipulations under inert atmospheres, chemists can choose between Schlenk or high-vacuum techniques and a glovebox. Schlenk and...
07:10
3D Depth Profile Reconstruction of Segregated Impurities Using Secondary Ion Mass Spectrometry
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2020
The presented method describes how to identify and solve measurement artifacts related to secondary ion mass spectrometry as well as obtain realistic 3D distributions of impurities/dopants in solid state materials.
11:42
Fabrication of Gate-tunable Graphene Devices for Scanning Tunneling Microscopy Studies with Coulomb Impurities
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Cited by 14 •
2015
This paper details the fabrication process of a gate-tunable graphene device, decorated with Coulomb impurities for scanning tunneling microscopy studies. Mapping the spatially dependent electronic structure of graphene in the presence of charged impurities unveils the unique behavior of its relativistic charge carriers in response to a local Coulomb potential.
01:19
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
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2025
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
08:29
Expression Profiling with Microarrays
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2023
Microarrays are important tools for profiling gene expression, and are based on complementary binding between probes that are attached to glass chips and nucleic acids derived from samples. Using these arrays, scientists can simultaneously evaluate the expression of thousands of genes. In addition, the expression profiles of different cells or tissue types can be compared, allowing researchers to deduce how the expression of different genes change during biological processes, and thus gain...
FAQs
Separation creates different retention behavior for chemical components, while detector responses indicate their relative signal levels. Analysts compare these observations with reference standards and, when needed, structural techniques to support identification. This combination helps determine whether a signal represents a known impurity and estimate its level in the sample.
The origin of an unwanted component provides different clues about control strategy. Process-related impurities point to manufacturing chemistry, degradation products can arise during storage, and contaminants represent introduced unwanted material. Separating these categories helps teams connect findings to purification, stability studies, manufacturing controls, and risk assessment rather than treating every signal identically.
Measured impurity levels provide evidence for setting product specifications and evaluating whether observed components require further control. Comparing amounts across samples or study conditions also supports risk assessment and helps reveal changes associated with manufacturing or storage. In clinical pharmaceutical development, these results contribute to decisions about consistency and suitability for patient use.
Changes in manufacturing or storage can alter which unwanted components are present and how much of each is detected. Profiling these samples alongside stability studies helps distinguish a manufacturing-related pattern from a degradation-related change. That comparison gives development teams evidence for evaluating product behavior over time and choosing appropriate purification or control measures.
An analysis generally separates components from the active pharmaceutical ingredient by chromatography, examines retention behavior and detector responses, and compares the findings with reference standards. Structural techniques may then support characterization of unidentified signals. Finally, analysts assess the amount present and relate the result to impurity origin, stability, specifications, or risk.
It is useful when teams evaluate manufacturing processes, investigate purification needs, conduct stability studies, or assess changes observed during storage. The approach can be applied to drug substances and pharmaceutical products, allowing development data to connect chemical findings with product consistency, specification setting, and decisions about suitability for clinical use.
By showing which unwanted components occur, at what levels, and under which manufacturing or storage context, the data support quality and regulatory control. In clinical development, this evidence helps assess whether a drug substance or product remains consistent and suitable for patient use, while also informing risk assessment and the setting of specifications.
It can indicate the component’s likely origin, its measured level, and its relationship to manufacturing or storage conditions. Retention behavior, detector response, reference-standard comparison, and structural techniques together provide a more informative picture than detection alone. These findings can guide purification, stability evaluation, specification setting, and broader pharmaceutical development decisions.