Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Method for detecting alanyl glutamine impurities in compound amino acid injection

A technology of alanyl glutamine and compound amino acids, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve problems such as complicated operation, expensive equipment, and detection interference

Active Publication Date: 2020-10-23
费森尤斯卡比华瑞制药有限公司
View PDF5 Cites 4 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alanylglutamine will degrade under the action of high temperature and other conditions. For compound products, when using conventional HPLC (high performance liquid chromatography) method to detect, complex amino acid components will Impurities L-pyroglutamic acid, cyclo-(L-alanyl-glutamine), L-pyroglutamyl-L-alanine and cyclo-(L-alanyl-glutamic acid) Detection can interfere
Simone [1] et al. used LC-ESI-MS / MS to detect the alanylglutamine impurity in parenteral amino acid injections, but LC-ESI-MS / MS equipment is expensive, and general laboratories do not have this condition
Simone [2] et al. used two-dimensional reverse chromatography × HILIC separation mode, IT-MS and CAD as detectors to analyze alanylglutamine impurities in parenteral amino acid injections. This method is expensive and complicated to operate, and is not available in general laboratories. the condition

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for detecting alanyl glutamine impurities in compound amino acid injection
  • Method for detecting alanyl glutamine impurities in compound amino acid injection
  • Method for detecting alanyl glutamine impurities in compound amino acid injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] A method for detecting impurities of alanylglutamine in compound amino acid injection, specifically comprising the following steps:

[0042] (1) Accurately weigh 56mg of L-pyroglutamic acid reference substance and place it in a 100mL measuring bottle, dissolve it with an appropriate amount of water and dilute to the mark to obtain a reference substance stock solution, and precisely pipette 1mL of L-pyroglutamic acid reference substance stock solution In a 250mL volumetric flask, dilute to the mark with water and shake well to obtain the working solution of the reference substance;

[0043] (2) Weigh 3.5g of Dowex 50w X8 resin into a 50mL beaker, soak in water for 1h, then carefully fill it into a glass chromatography column, rinse with 30mL of water, accurately draw 2mL of the sample into the chromatography column, and rinse with water, Collect the eluent into a 100mL volumetric flask to obtain the test solution;

[0044] (3) Determine the high performance liquid chrom...

Embodiment 2

[0062] A method for detecting impurities of alanylglutamine in compound amino acid injection, specifically comprising the following steps:

[0063] (1) Accurately weigh 56mg of L-pyroglutamic acid reference substance and place it in a 100mL measuring bottle, dissolve it with an appropriate amount of water and dilute to the mark to obtain the reference substance stock solution, and precisely pipette the L-pyroglutamic acid reference substance stock solution Dilute 1mL in a 250mL volumetric flask to the mark with water and shake well to obtain the working solution of the reference substance;

[0064] (2) Weigh 3.5g of Dowex 50w X8 resin into a 50mL beaker, soak in water for 1h, then carefully fill it into a glass chromatography column, rinse with 30mL of water, accurately draw 2mL of the sample into the chromatography column, and rinse with water, Collect the eluent into a 100mL volumetric flask to obtain the test solution;

[0065] (3) Determine the high performance liquid chr...

Embodiment 3

[0083] A method for detecting impurities of alanylglutamine in compound amino acid injection, specifically comprising the following steps:

[0084] (1) Accurately weigh 56mg of L-pyroglutamic acid reference substance and place it in a 100mL measuring bottle, dissolve it with an appropriate amount of water and dilute to the mark to obtain the reference substance stock solution, and precisely pipette the L-pyroglutamic acid reference substance stock solution Dilute 1mL in a 250mL volumetric flask to the mark with water and shake well to obtain the working solution of the reference substance;

[0085] (2) Weigh 3.5g of Dowex 50w X8 resin into a 50mL beaker, soak in water for 1h, then carefully fill it into a glass chromatography column, rinse with 30mL of water, accurately draw 2mL of the sample into the chromatography column, and rinse with water, Collect the eluent into a 100mL volumetric flask to obtain the test solution;

[0086] (3) Determine the high performance liquid chr...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Particle sizeaaaaaaaaaa
Wavelengthaaaaaaaaaa
Login to View More

Abstract

The invention belongs to the technical field of medicinal chemistry detection, and particularly relates to a method for detecting alanyl glutamine impurities in a compound amino acid injection. The detection method provided by the invention comprises the following steps: preparing an L-pyroglutamic acid reference substance solution; preparing a compound amino acid injection (containing alanyl glutamine) test solution by adopting cation exchange resin; determining high performance liquid chromatography conditions, detecting the L-pyroglutamic acid reference substance solution and the compound amino acid injection test solution by adopting high performance liquid chromatography, and calculating the content of alanyl glutamine impurities in the test solution by using a correction factor method. The method can accurately detect the content of the alanyl glutamine impurities in the complex sample, does not involve the use of an organic solvent in the experiment process, only uses the pyroglutamic acid with low price as a reference substance, and greatly saves the daily detection cost.

Description

technical field [0001] The invention belongs to the technical field of medicinal chemistry detection, and in particular relates to a detection method for alanyl glutamine impurity in compound amino acid injection. Background technique [0002] Alanylglutamine is a very important dipeptide in parenteral nutrition products. It can be quickly decomposed into two essential amino acids in the human body: alanine and glutamic acid, and has no toxic side effects. The application of external nutrition is getting more and more attention. Alanylglutamine will degrade under the action of high temperature and other conditions. For compound products, when using conventional HPLC (high performance liquid chromatography) method to detect, complex amino acid components will Impurities L-pyroglutamic acid, cyclo-(L-alanyl-glutamine), L-pyroglutamyl-L-alanine and cyclo-(L-alanyl-glutamic acid) Detection can interfere. Simone [1] et al. used LC-ESI-MS / MS to detect the alanylglutamine impur...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 胡雪连张倩何翠翠陈晋苏
Owner 费森尤斯卡比华瑞制药有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com