摘要:
The present invention provides a process for characterizing a glatiramer acetate, related drug substance (GARDS) or a glatiramer acetate related drug product (GARDP) comprising separating a batch of a GARDS or GARDP according to hydrophobicity and determining the molar mass of the separated material, thereby characterizing the GARDS or GARDP by molar mass as a function of hydrophobicity.
摘要:
A method for the quantitative characterization of amyloid and/or aggregated peptides and/or proteins in a sample, comprising: providing a sample, wherein the sample includes an amyloid and/or aggregated peptide and/or protein having at least one aggregate size and shape; adding an active ingredient to be analyzed to the sample solution; separating the amyloid and/or aggregated peptides and/or proteins are from one another according to their aggregate size and shape; optionally completely denaturing the amyloid and/or aggregated peptides and/or proteins of a particular fraction into monomer building blocks; determining the change in concentration of the peptide and/or protein building blocks in at least one fraction by comparison against control values without the active ingredient.
摘要:
Disclosed are systems and methods that include providing a vessel having an inlet and an outlet for communicating a carrier gas through the vessel; determining a differential pressure between the inlet and the outlet for a known flow rate at the outlet; and, determining a unit flow per unit pressure based on a ratio of the flow rate and the differential pressure. In certain embodiments, the flow rate at the outlet is established by controlling the flow rate of the gas. In some embodiments, the methods and systems can include a viscosity in the ratio, determining a flow rate at ambient pressure using a factor based on a ratio of a gas pressure at the output and ambient pressure, and/or, determining a flow rate at ambient temperature using a factor based on a ratio of a temperature at the output and ambient temperature.
摘要:
Disclosed are systems and methods that include providing a vessel having an adsorbent disposed therein, the vessel having an inlet and an outlet for communicating a carrier gas through the vessel; determining a differential pressure between the inlet and the outlet for a known flow rate at the outlet; and, determining a geometric measure for the vessel based on a ratio of the known flow rate and the differential pressure. In some embodiments, the methods and systems can include a viscosity in the ratio, determining a flow rate at ambient pressure using a factor based on a ratio of a gas pressure at the output and ambient pressure, and/or, determining a flow rate at ambient temperature using a factor based on a ratio of a temperature at the output and ambient temperature.
摘要:
Disclosed are systems and methods that include providing a vessel having an adsorbent disposed therein, the vessel having an inlet and an outlet for communicating a carrier gas through the vessel; determining a differential pressure between the inlet and the outlet for a known flow rate at the outlet; and, determining a geometric measure for the vessel based on a ratio of the known flow rate and the differential pressure. In some embodiments, the methods and systems can include a viscosity in the ratio, determining a flow rate at ambient pressure using a factor based on a ratio of a gas pressure at the output and ambient pressure, and/or, determining a flow rate at ambient temperature using a factor based on a ratio of a temperature at the output and ambient temperature.
摘要:
The present invention provides a method for determining drug permeability, wherein the method comprises, for each reference drug of at least two reference drugs having (i) the same ionization state at a given pH and (ii) a known drug permeability determined by the same drug permeability testing technique, the calculation of a metric related to retention time of each reference compound eluted from a liquid chromatography column having an immobilized artificial membrane functional group. Then, based on each metric and each known drug permeability, drug permeability is expressed as a function of the metric. The method may further comprise the calculation of the metric related to retention time for a further drug eluted from the liquid chromatography column, the further drug having the same ionization state at the given pH and an unknown drug permeability, and an assessment of drug permeability for the further drug, based on the metric for the further drug and the function.
摘要:
The measurement of multiple membrane affinities of test compounds, methods and compositions useful for acquiring data characteristic of such affinities, and a method and system for using such data alone or in combination with other molecular descriptors for the prediction of biological activity are described. The numerical values characteristic of biologically relevant interaction of test compounds with membrane mimetic surfaces are compared with corresponding values of one or more control compounds having a known biological activity. Probable biological activity of a test compound is identified with those control compounds whose multiple membrane interaction values most closely correlate to those of the test compound.
摘要:
This invention provides a immobilized receptors on supports in liquid chromatographic systems. The method of the invention provides means of evaluating the attachment of agents to receptors comprising the steps of: (a) immobilizing receptors on artificial membrane supports in a column, (b) exposing the supports with the receptors to test agents at varying concentrations in a liquid chromatographic system, (c) eluting the test agent from the column, and (d) evaluating the elution profile of the test materials from the column. Using this method, it is possible to evaluate the interaction of the test agent with the receptor. Following elution, it is possible to directly determine molecular structure by passing the elute through other testing devices such as a mass spectrometer.
摘要:
Disclosed is a method of determining a diffusion coefficient for a diffusant in a particulate. An inert gas is passed through a particulate containing the diffusant. A parameter that is proportional to the concentration of the diffusant in the inert gas is measured over a period of time and the slope of the linear portion of that relationship is determined and is multiplied by a constant.
摘要:
Process for evaluating the catalytic performance of a porous solid using a vapor diffusion technique, where a probe molecule and a molecule for dead-time determination is injected into a carrier gas that is then contacted with the porous solid in a vessel, where a detector analyzes the peak width and retention time of a probe molecule and the retention time of the molecule for dead-time determination in the gas exiting the vessel.