265 results about "CMC chromatography" patented technology

The invention provides a construction method and application of a fingerprint spectrum of a liver-warming decoction, and belongs to the technical field of medicine detection.The construction method includes the steps that a test solution is prepared through the liver-warming decoction, acetonitrile (A)-0.08-0.12 wt% formic acid aqueous solution (B) serves as a mobile phase, and the fingerprint spectrum of the liver-warming decoction is obtained through high performance liquid chromatography detection; and a standard fingerprint spectrum is established and is used for quality evaluation or control in the whole process of research / development / production / clinical application of the liver-warming decoction. According to the construction method of the fingerprint spectrum of the liver-warming decoction, main medicinal material components in the liver-warming decoction can be detected through high performance liquid chromatography, so that the quality condition of the liver-warming decoction can be reflected more comprehensively.

The invention relates to a method for detecting six second-line antituberculous drugs by high performance liquid chromatography. The method comprises the following steps: providing an internal standard stock solution and a standard stock solution of six second-line antituberculosis drugs; preparing an internal standard working solution and a standard curve working solution by utilizing the diluent; preparing a solution of a product to be detected by using the Tianlongitudinal sample extraction liquid TZ-002; a liquid chromatograph is used for detection, and the conditions are as follows: a mobile phase A is a Tianlongitudinal sample releasing agent TZ-D004; a mobile phase B is acetonitrile; a mobile phase C is water; and gradient elution. According to the method, the plasma concentration of the second-line antituberculous drug taken by a tuberculosis patient is measured by applying the reversed-phase high-performance liquid chromatography, the cost is relatively low, the analysis time is short, the sensitivity is high, and the accuracy is high. The kit can be used for simultaneously detecting the blood concentration of six second-line antituberculosis drugs such as isopropylthioamide, levofloxacin, linezolid, moxifloxacin, deramanib and bedaquiline in human serum, and is expected to provide a more reliable basis for clinicians to adjust the dosage of the antituberculosis drugs.

Provided is a method for large-scale preparation of a purified preparation of a recombinant lentiviral vector at the GMP grade. The method comprises: (a) providing raw material feed liquid to be purified that comprises recombinant viral vectors; (b) carrying out a microfiltration treatment on the feed liquid to obtain a microfiltered filtrate comprising the recombinant viral vectors; (c) optionally concentrating the filtrate to obtain a concentrated filtrate; (d) purifying the filtrate obtained in the previous step by means of chromatography to obtain a crude pure product comprising the recombinant viral vectors; and (e) subjecting the crude pure product obtained in the previous step to liquid exchange and elaborate purification to obtain the purified recombinant viral vectors.

Provided herein are methods for purifying polypeptides (e.g., antibodies) comprising an Fc region by Protein A chromatography; methods for using wash solutions comprising benzoate and / or benzyl alcohol during Protein A chromatography; and methods for conditioning the harvest using sodium benzoate prior to Protein A chromatography. [Selected Figure] Figure 1

The invention discloses a method for detecting the content of nicotinamide mononucleotide, ergothioneine and nicotinamide. According to the method, the content of nicotinamide mononucleotide, ergothioneine and nicotinamide in a sample is analyzed by adopting a high performance liquid chromatography; according to the method, a CAPCELL PAK ADME chromatographic column is used, and the molecular weight of the CAPCELL PAK ADME chromatographic column is 100 And an acetonitrile-buffer solution is used as a mobile phase. Chromatographic peaks obtained by the method are sharp and symmetrical in shape, good in area reproducibility, good in separation degree, simple, rapid, high in specificity, short in detection period and high in sensitivity; the contents of nicotinamide mononucleotide, ergothioneine and nicotinamide in a sample can be rapidly, efficiently, accurately and simultaneously detected.

The current invention reports a method for purifying an antibody by reducing the content of a host cell protein. The method employs a wash step with a low conductivity aqueous solution in an affinity chromatography.

The invention belongs to the technical field of medicine detection, and particularly relates to a method for determining the content of impurities in OAB-14 by using high performance liquid chromatography. The method comprises the following steps: preparing a test sample labeling solution, a test sample solution and a contrast solution of OAB-14, respectively injecting the test sample labeling solution, the blank solution, the contrast solution and the test sample solution into a liquid chromatograph, recording chromatograms, and calculating according to a main component self-contrast method to obtain the content of impurities in the test sample solution; wherein the impurities are one or more of an impurity A, an impurity B, an impurity C, an impurity D, an impurity E or an impurity F. According to the method, the impurities in the OAB-14 can be qualitatively and quantitatively measured at the same time, the stability and the reproducibility are good, the separation degree between a main peak and each impurity peak is good, the precision is high, and an analysis means is provided for quality control of the OAB-14.

The invention belongs to the technical field of medical analysis, and particularly relates to a method for separating chemical components in hemsley rockvine root. According to the present invention, various chromatography methods are adopted to carry out separation and purification, such that sitroside (I), vanillyl glycolII (II), 5-hydroxymaltol (III), vanillic acid (IV), afzelin (V), 2, 3-dihydroxypyrazole (9E, 11E)-13-hydroxypyrazole (9, 11-dienoate), and 2, 3-dihydroxypyrazole (10E, 12E)-9-hydroxypyrazole (10, 12-dienoate) are obtained from hemsley rockvine root. Wherein the compounds II, III, VI and VII are separated from the hemsley rockvine root for the first time, and development and quality control of the hemsley rockvine root medicinal material are facilitated.

The invention belongs to the technical field of pharmaceutical analysis, and discloses a method for determining two potential genotoxic impurities in carbon [13C]-urea by gas chromatography. Comprising the following steps: (1) preparing a sample solution; (2) preparing a reference solution; (3) taking nitrogen as carrier gas, and detecting by adopting a medium-polarity or weak-polarity chromatographic column separation system; and (4) calculating by a peak area through an external standard method to obtain the accurate contents of methyl carbamate and ethyl carbamate in the carbon [13C]-urea. The method disclosed by the invention is simple to operate, good in specificity, linearity, precision and accuracy and high in sensitivity, and can realize accurate detection of residual potential genotoxic impurities, namely methyl carbamate and ethyl carbamate, in the carbon [13C]-urea.

Provided herein are fusion proteins and methods for purifying nucleic acids from a composition. The disclosed compositions and methods allow for faster, more efficient purification of nucleic acids compared to traditional affinity chromatography.

This invention generally relates to methods for enriching antibodies of interest. Specifically, this invention relates to enriching therapeutic antibodies from upstream cell culture processes using protein A chromatography in the form of a centrifugal column for product quality property profiling analysis.

To provide a method for increasing an antibody yield during antibody purification.SOLUTION: A method for increasing an antibody yield in a flow-through of ion exchange chromatography during antibody purification includes: a. a step of providing a sample including an antibody; b. a step of adjusting the electric conductivity of the sample; c. a step of processing the adjusted sample by ion exchange chromatography of a flow-through mode; and d. a step of collecting the flow-through including the antibody, where the electric conductivity of the sample on step b) is adjusted to at least 10 mS / cm by using tris, and pH after adjusting electric conductivity is within the range of pH6.5 to 7.5.SELECTED DRAWING: None

The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.

The invention relates to a detection method of a revivacin inhalation solution, and belongs to the technical field of medicine detection. According to the detection method provided by the invention, a revivin inhalation solution sample is analyzed by adopting high performance liquid chromatography to obtain the content of impurities in the revivin inhalation solution; the high performance liquid chromatography uses a phosphate buffer as a mobile phase A and acetonitrile as a mobile phase B, and the elution conditions are as follows: 0-5 min, the volume ratio of the mobile phase A to the mobile phase B is gradually changed from 95: 5 to 80: 20; the volume ratio of the mobile phase A to the mobile phase B is gradually changed from 80: 20 to 20: 80 in 5-30 min; the volume ratio of the mobile phase A to the mobile phase B is 95: 5. The method provided by the invention can realize accurate detection of five different impurities in the revienacin inhalation solution, and is beneficial to actual production quality control and improvement of drug safety.

The invention relates to the technical field of thin-layer chromatography detection, and discloses a thin-layer chromatography separation method for amino polyether and a matrix in a fluorine-18 labeled radiopharmaceutical, and the adopted developing solvent is acetonitrile and ammonia water, and the volume ratio of the acetonitrile to the ammonia water is 90: 10-85: 15. According to the method, amino polyether and matrix components are separated by adopting a developing solvent with a specific volume ratio, and particularly, sodium ascorbate in the amino polyether and the matrix is separated.

To provide methods and systems for improving the efficiency and / or productivity of polypeptide preparation.SOLUTION: The embodiment of the disclosure is directed to a method for preparing a target polypeptide from a mixture containing the target polypeptide. The method comprises contacting the mixture to a hydrophobic interaction chromatography (HIC) apparatus consisting of multiple chromatography zones. The method may further comprise passing the target polypeptide through the outlets of at least first and second zones. The residence time for the mixture including the target polypeptide in the first zone may be substantially the same as a residence time of one or more mobile phases in the second zone.SELECTED DRAWING: Figure 2

The present disclosure relates to a method for separating and obtaining a target protein-enriched solution, such as immunoglobulin G (IgG), and a plurality of target protein-depleted fractions from a protein mixture, such as plasma or fractions thereof, using continuous chromatography. The present disclosure also relates to a continuous chromatography system for separating a target protein from a protein mixture, a formulation of its purified product and uses.

The invention relates to the technical field of pharmaceutical analysis, in particular to a chromatographic method for determining optical isomers in a carbidopa raw material medicine and a preparation thereof by using an HPLC (High Performance Liquid Chromatography) method. The detection method is simple, convenient, rapid and accurate to operate, and specifically comprises the following steps: dissolving a proper amount of a sample with a solvent, diluting to a certain concentration, taking a certain volume of the sample, carrying out isocratic elution at a certain column temperature by adopting a high performance liquid chromatography, using a hand-type chromatographic column, a mobile phase A and a mobile phase B, and carrying out quantitative analysis by adopting a self-control method with correction factors. And calculating the isomer in the test solution. The method is good in specificity, solution stability, linearity, repeatability, intermediate precision and durability, and the detection result is accurate and reliable through verification.

The invention discloses a method for detecting related substances in testosterone enanthate by high performance liquid chromatography. A mobile phase A and a mobile phase B are used as mixed mobile phases for gradient elution; the mobile phase A is water; the mobile phase B is acetonitrile; the volume ratio of the mobile phase A to the mobile phase B is (5%-70%): (30%-95%); a chromatographic column adopted by the high performance liquid chromatography method is Agilent ZORBAX Eclipse XDB-C8, and the detection method is characterized in that the detection method is simple and easy to implement. According to the method, the testosterone enanthate and the related substances thereof are separated and detected by screening a stationary phase chromatographic column and optimizing a mobile phase elution mode and an elution component ratio, and compared with a method in European Pharmacopoeia, after the chromatographic column is subjected to gradient elution, not only is the retention time of an impurity D prolonged, but also the quality of the impurity D is improved. And the separation degree of the impurity F and the impurity G is increased, so that the elution capacity and the separation degree among the impurities are enhanced.

The invention belongs to the technical field of biological medicines, and particularly relates to a dissociation liquid applied to an aluminum adjuvant adsorption influenza vaccine and a method for measuring the antigen content. The dissociation liquid disclosed by the invention is prepared from a potassium phosphate salt solution, diethanol amine, TritonX-100, tween-20, dodecyl dimethyl betaine and water. The dissociation liquid is excellent in dissociation efficiency, the dissociation recovery rate of the dissociation liquid to H1N1, H3N2 and BV type influenza vaccine hemagglutinin reaches 106%-110%, the antigen activity can be effectively protected, operation is easy and convenient, adaptability is wide, a dissociated sample can be directly used for mainstream detection methods such as a one-way immunodiffusion test, an enzyme-linked immunosorbent assay and a high performance liquid chromatography method, and the dissociation liquid has good application prospects. The precise quantification of the antigen content in the aluminum adjuvant adsorption influenza vaccine is realized, and a reliable technical support is provided for vaccine quality control.

Provided are: particles of a recycled polycarbonate resin which are characterized by having an oligomer content of 1.4% or less and a molecular weight distribution (Mw / Mn) of 2.3 or less, both determined by gel permeation chromatography (GPC); or particles of a recycled polycarbonate resin which are characterized by having an oligomer content of 0.8% or less and a molecular weight distribution (Mw / Mn) of 2.3 or less, both determined by gel permeation chromatography (GPC), and having a specific surface area of 0.05-1.2 g / cm3 as determined by a gas adsorption method. The particles of a recycled polycarbonate resin have a feature of having excellent impact resistance, heat resistance (hue after molding), and transparency.

A chromatographic system for the simultaneous RP-HPLC quantification of aloin and curcumin, consisting of a C18 column, a PDA detector, a programmable solvent feed module and an optimized mobile phase of acetonitrile, methanol and water.

The application discloses a liquid-phase detection method for curcumin related substances and application thereof, characterized in that the method adopts high performance liquid chromatography, and the chromatographic conditions comprise that a mobile phase A is a 1% mass concentration phosphoric acid aqueous solution; a mobile phase B is acetonitrile; gradient elution is adopted, and the program of the gradient elution is as follows: 0-11 min, the volume percentage of the mobile phase A changes from 60% to 38%; 11-15 min, the volume percentage of the mobile phase A remains 38%; 15-20 min, the volume percentage of the mobile phase A changes from 38% to 30%; and 20-30 min, the volume percentage of the mobile phase A remains 30%. The application can effectively alleviate the problem of unstable baseline caused by curcuminone-enol tautomerism, and can simultaneously separate and detect multiple related substances including vanillin, acetylacetone and ketone isomers, and has the characteristics of high resolution, good specificity and high sensitivity.

The invention relates to the technical field of analytical chemistry, and discloses a method for determining the glyphosate content in water by high performance liquid chromatography. The method comprises the following steps: preparing a standard substance series solution and a quality control sample solution covering a predetermined concentration range; performing physical and chemical pretreatment on the target water sample to obtain a purified sample. Then, respectively injecting the purified water sample and the standard substance solution into a chromatographic system for separation, and collecting original chromatographic signals; retention time and peak area parameters of a glyphosate characteristic chromatographic peak are extracted, a quantitative calibration relation is established by using standard product data, and accordingly, the peak area of a target water sample is converted into a preliminary result of glyphosate concentration. And finally, introducing a quality control sample to carry out quality control verification, carrying out validity judgment on the preliminary result according to the generated quality control index, and outputting a final glyphosate content measured value. According to the method, the accuracy and reliability of a measurement result are ensured, and the interference risk caused by a complex water sample matrix is reduced.

The application discloses a method for detecting the content of multi-component leachable of intraocular lens by liquid chromatography, comprising the following steps: preparing a series of standard solutions with different concentrations of the leachable of intraocular lens; performing gradient elution on the standard solutions of the leachable of intraocular lens by liquid chromatography to obtain chromatograms of the leachable corresponding to different retention times, and drawing standard curves of the standard solutions according to the concentration-peak area; adding the intraocular lens sample to be detected into an organic solvent and placing the sample in a water bath to simulate extraction to obtain a test sample solution of the multi-component leachable of the sample; performing liquid chromatography on the test sample solution to obtain a sample chromatogram; and using an external standard method to qualitatively and quantitatively analyze the leachable components in the test sample solution according to the sample chromatogram and the results obtained by the standard solutions. The method can qualitatively and quantitatively analyze multiple components at one time, has good chromatographic separation and linear relationship, high precision and accuracy, and is simple, rapid and efficient.

The invention belongs to the technical field of drug analysis, and discloses a method for determining photodegradation impurities in ofloxacin ear drops, which adopts high performance liquid chromatography, takes octadecylsilane chemically bonded silica as a filler, and takes a citric acid solution and acetonitrile as mobile phases to analyze the impurities generated by photodegradation in the ofloxacin ear drops. And measuring the peak area of the impurities in the test solution and the main peak area of the contrast solution by adopting a main component self-contrast method without adding a correction factor, and calculating the content of the impurities. The method can rapidly and accurately analyze ofloxacin photodegradation impurities, is strong in specificity, good in separation degree, stable and reliable, and can realize quality control of ofloxacin ear drops.

The present invention relates to means and methods for the one-step affinity purification of a polypeptide of interest controlled by light. Accordingly, the present invention relates to a polypeptide comprising an N-terminal or C-terminal light-responsive affinity tag, wherein said N-terminal or C-terminal light-responsive affinity tag may comprise a non-natural light-responsive amino acid. Accordingly, the present invention further relates to such light-responsive affinity tags. Further provided herein are means and methods for the recombinant coupling of such non-natural light-responsive amino acids and / or light-responsive affinity tags to a polypeptide of interest. Provided herein is also a solid (stationary) phase to be employed with said light-responsive affinity tag in a method for the purification of said polypeptide of interest. Further provided is a kit comprising any of the above.

The invention relates to a detection method of an infantile cough and asthma composition, and belongs to the technical field of detection. The detection method of the infantile cough and asthma composition comprises the following steps: S1, adding the infantile cough and asthma composition into methanol for reflux, cooling and filtering to obtain a to-be-detected solution; s2, determining the liquid to be detected by adopting a high performance liquid chromatography to obtain the contents of aesculin and aesculetin in the infantile cough and asthma composition, according to the high performance liquid chromatography, a phosphoric acid aqueous solution is used as a mobile phase A, methanol is used as a mobile phase B, and specific elution conditions are adopted. The aesculin and aesculetin obtained by the detection method for the infantile cough and asthma composition are good in peak pattern and can be well separated from front and rear peaks, the detection method which is high in accuracy, good in precision, good in durability and suitable for large-scale production quality control is provided, and detection of main components of the infantile cough and asthma composition can be achieved.