Disclosed is a method for monitoring of foulants present on chromatographic resins using fluorescence probe. The method comprises packing a chromatographic column with a fresh chromatographic resin. The resin packed chromatographic column is washed and an initial reading of fluorescence intensity of the chromatographic resin is measured. The column is then subjected for protein purification followed by excitation of the column at a predefined wavelength. The final reading of fluorescence intensity is measured at a predefined wavelength and the foulant deposited on the column is determined by subtracting the initial reading from the final reading of the fluorescence intensity.

Disclosed are non-continuous sample fractionating and concatenating device and a dual online multidimensional liquid chromatography system having the same. The non-continuous sample fractionating and concatenating device according to an embodiment of the present disclosure includes a sample supply module which supplies a sample to be analyzed, and a sample fractionation module connected to the sample supply module, and which is continuously supplied with the sample, sets a plurality of unit sample supply times obtained by equally dividing a total sample supply time during which the sample is supplied from the sample supply module, sets a plurality of unit fractionation intervals obtained by equally dividing each of the plurality of unit sample supply times, and concatenates and stores the sample supplied during corresponding unit fractionation intervals within each unit sample supply time to acquire a plurality of fractions.

Disclosed are non-continuous sample fractionating and concatenating device and a dual online multidimensional liquid chromatography system having the same. The non-continuous sample fractionating and concatenating device according to an embodiment of the present disclosure includes a sample supply module which supplies a sample to be analyzed, and a sample fractionation module connected to the sample supply module, and which is continuously supplied with the sample, sets a plurality of unit sample supply times obtained by equally dividing a total sample supply time during which the sample is supplied from the sample supply module, sets a plurality of unit fractionation intervals obtained by equally dividing each of the plurality of unit sample supply times, and concatenates and stores the sample supplied during corresponding unit fractionation intervals within each unit sample supply time to acquire a plurality of fractions.

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.

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.

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.

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.

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.

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.

The present invention provides an analysis method including separating a compound of the formula (1):

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contained in a polyoxyethylene derivative by reversed-phase chromatography, and detecting the compound with an ultraviolet visible spectrometer detector, in which ultraviolet light with a wavelength shorter than 200 nm as the detection wavelength is used, and an acidic substance with a maximum molar absorption coefficient of not more than 20 M.sup.?1cm.sup.?1 at 190 to 200 nm and a pKa of not more than 4 is used as an additive to the mobile phase for analysis.