A detection method for related substances of l-2-amino-5-guanidinovaleric acid
A technology of arginine and related substances, which is applied in the field of detection of L-2-amino-5-arginine related substances, and can solve the problem of inability to clearly state the existence status, potential safety hazards of clinical medication, unfavorable preparation quality control, etc. problems, to achieve the effect of ensuring food and medicinal safety, good product quality control, good control and mastery
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0051] Example 1: Detection of three batches of L-2-amino-5-guanidinovaleric acid bulk drug and its related substances
[0052] Instrument and chromatographic conditions:
[0053] Agilent 1260 high performance liquid chromatography was used, with octadecylsilane bonded silica gel as filler (4.6×250mm, 5μm), column temperature was 30°C; flow rate was 0.5mL / min; detection wavelength was 210nm; injection volume Take 3.9 grams of sodium dihydrogen phosphate, add water to dissolve and dilute to 1000 mL, use 20% phosphoric acid to adjust the pH value to 2.3 as mobile phase A, use acetonitrile as mobile phase B, and perform elution in the following table, and the ratio is as follows:
[0054]
[0055] Precisely measure 20 μL each of the test solution, the reference solution and the control solution, inject them into the liquid chromatograph, and record the chromatograms;
[0056] According to the external standard method, 2-ketoglutaric acid (impurity A), (S)-2-acetylaminoglutari...
Embodiment 2
[0065] Embodiment 2: related substance localization test
[0066] Instrument and chromatographic conditions are the same as in Example 1.
[0067] Experimental procedure: Weigh the appropriate amount of impurity A, impurity B, and impurity C reference substances, respectively dissolve them with diluent and quantitatively dilute them to make a solution containing about 2.5 μg of impurity A, impurity B, and 0.25 μg of impurity C per 1 mL as The positioning solution of each impurity; the preparation method of the mixed solution is the same as the system suitability solution of embodiment 1, and the positioning solution and the mixed solution of the above-mentioned impurities are injected into the liquid chromatograph respectively, and the chromatogram is recorded. The separation results of L-2-amino-5-guanidinovaleric acid and various impurities are shown in the table below, and the chromatogram is shown in image 3 :
[0068]
[0069] The results showed that all the related...
Embodiment 3
[0070] Embodiment 3: Specific destruction test
[0071] Instrument and chromatographic conditions are the same as in Example 1.
[0072] Experimental procedure: Weigh an appropriate amount of impurity A, impurity B, and impurity C reference substances, respectively, dissolve them with diluent and quantitatively dilute them to make solutions containing about 2.5 μg of impurity A, impurity B, and 0.25 μg of impurity C per 1 mL as the respective solutions. The positioning solution of impurities; the preparation method of the mixed solution is the same as the system suitability solution of embodiment 1, and the positioning solution and the mixed solution of the above-mentioned impurities are injected into the liquid chromatograph respectively, and the chromatograms are recorded. The separation results of L-2-amino-5-guanidinovaleric acid and various impurities are shown in the table below, and the chromatogram is shown in image 3 :
[0073] Accurately weigh an appropriate amoun...
PUM
Property | Measurement | Unit |
---|---|---|
concentration | aaaaa | aaaaa |
recovery rate | aaaaa | aaaaa |
Abstract
Description
Claims
Application Information
- R&D Engineer
- R&D Manager
- IP Professional
- Industry Leading Data Capabilities
- Powerful AI technology
- Patent DNA Extraction
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