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With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
nano-Differential scanning fluorimetry, or nanoDSF, is a biophysical characterization technique used for assessing the conformational stability of a biological sample, typically a protein. [2] Samples are subjected to either temperature ramps or gradients of chemical denaturant, and the intrinsic fluorescence is measured and fit to determine ...
Differential scanning calorimetry (DSC) is a thermoanalytical technique in which the difference in the amount of heat required to increase the temperature of a sample and reference is measured as a function of temperature. [1] Both the sample and reference are maintained at nearly the same temperature throughout the experiment.
Sample preparation (including homogenization, stabilization, bottling etc.) Homogeneity testing; Stability assessment; Value assignment ("characterization" in ISO REMCO terms). [18] In addition it may be important to assess the commutability of a reference material; this is especially important for biological materials. [9]
In the 20th century, the use of blood and serum collected and dried on a filter paper for serologic testing for syphilis was already reported. Both field and home sample collections were described. [3] The first report of blood absorbed onto filter paper for enzyme measurements was published in 1953. [3] [5]
Sample preparation for mass spectrometry is used for the optimization of a sample for analysis in a mass spectrometer (MS). Each ionization method has certain factors that must be considered for that method to be successful, such as volume, concentration, sample phase, and composition of the analyte solution. Quite possibly the most important ...
Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
An example SDS, including guidance for handling a hazardous substance and information on its composition and properties. A safety data sheet (SDS), [1] material safety data sheet (MSDS), or product safety data sheet (PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products.