Name | L-ornithine L-aspartate salt |
Synonyms | L-Orn-L-Asp Ornithne Aspartate Ornithine Aspartate L-Ornithine Aspartate L-Ornithine-L-aspartate L-Ornithine L-Aspartate L-ornithine L-aspartate salt (2S)-2-amino-4-hydroxy-4-oxobutanoate (2S)-2-amino-4-hydroxy-4-keto-butyrate (2S)-2-azanyl-4-hydroxy-4-oxo-butanoate [(4S)-4-amino-5-hydroxy-5-oxopentyl]azanium [(4S)-4-azanyl-5-hydroxy-5-oxo-pentyl]azanium [(4S)-4-amino-5-hydroxy-5-keto-pentyl]ammonium 5-ammonio-L-norvaline (2S)-2-amino-3-carboxypropanoate |
CAS | 3230-94-2 |
EINECS | 221-772-7 |
InChI | InChI=1/C5H12N2O2.C4H7NO4/c6-3-1-2-4(7)5(8)9;5-2(4(8)9)1-3(6)7/h4H,1-3,6-7H2,(H,8,9);2H,1,5H2,(H,6,7)(H,8,9)/p-1/t4-;2-/m00/s1 |
InChIKey | IXUZXIMQZIMPSQ-UHFFFAOYSA-N |
Molecular Formula | C9H19N3O6 |
Molar Mass | 265.26 |
Melting Point | 202.0 to 206.0 °C |
Solubility | Aqueous Acid (Sparingly) |
Appearance | powder |
Color | white |
Merck | 14,6874 |
Storage Condition | 2-8°C |
Sensitive | Easily absorbing moisture |
MDL | MFCD00058084 |
Physical and Chemical Properties | L-ornithine-L-aspartate is a stable dipeptide compound prepared by chemical synthesis of L-ornithine and L-aspartic acid. It is highly soluble in water and almost insoluble in methanol or ethanol. This product enters the human body, that is, the decomposition of aspartate and ornithine, can directly participate in liver cell metabolism, and can activate the liver detoxification function of the two key enzymes, which can help to remove harmful free radicals, enhance the detoxification function of the liver, quickly reduce the excessive blood ammonia, promote the repair and regeneration of liver cells, so as to effectively improve liver function and restore the energy balance of the body. |
Hazard Symbols | Xi - Irritant |
Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin. |
Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S37/39 - Wear suitable gloves and eye/face protection S24/25 - Avoid contact with skin and eyes. |
WGK Germany | 2 |
RTECS | CI9463000 |
HS Code | 29224999 |
This product is (S)-2, 5-diaminopentanoic acid-(S)-2-aminobutanediate. Calculated as dried product, containing no less than 98.0% of C5H12N2O2 • C4H7NO4.
take this product, precision weighing, add hydrochloric acid solution (6-10) to dissolve and dilute the solution containing 80mg per lm l, determination according to law (General 0621), the specific rotation was 27.0 ° to 29.0 °.
take 0.5g of this product, add water 20ml to dissolve, according to the law (General 0631),pH value should be 6.0~7.0.
take 0.5g of this product, add water 20ml to dissolve, according to UV-visible spectrophotometry (General rule 0401), determine the transmittance at 430mn wavelength, not less than 98.0%.
take about 0.4g of this product, weigh it accurately, put it in a 100ml measuring flask, add 0.O2mol/L potassium dihydrogen phosphate buffer solution 40ml to dissolve, dilute to the scale with acetonitrile, shake, as a test solution; Take appropriate amount of precision, quantitative dilution with mobile phase to make a solution containing ornithine aspartate 4ug per lml, as a control solution; Other precision weighing maleic acid, fumaric acid, arginine, 3-amino-2-piperidone (impurity I) and aspartic acid condensate (impurity II), separately, the mobile phase was added to dissolve and diluted to prepare a solution containing about 4ug of each 1 ml as a reference solution for each impurity; Ornithine aspartate, maleic acid, fumaric acid, arginine, appropriate amount of each reference substance of impurity I and impurity II, in the same measuring flask, add appropriate amount of mobile phase to dissolve and dilute to make 4mg ornithine aspartate per 1 ml, maleic acid, fumaric acid, arginine, A solution of 4ug each of impurity I and impurity II was used as a system-suitable solution. According to the high performance liquid chromatography (General rule 0512) test, using amino bonded silica gel as filler; 0.02mol/L potassium dihydrogen phosphate buffer solution (take potassium dihydrogen phosphate 2.72g, add water 500ml to dissolve, add 5ml of concentrated ammonia solution, dilute to 5.60±0.05 ml with water, adjust pH value to 1.3 with phosphoric acid after mixing well-acetonitrile (40:60) as mobile phase; The detection wavelength is 205nm; The flow rate is ml per minute; the column temperature was 30°C. 20ul of the applicable solution of the system is taken and injected into the liquid chromatograph. The separation degree between the peaks of aspartic acid, ornithine, maleic acid, fumaric acid, amino acid, impurity I and impurity II shall meet the requirements. 20 u1 of each of the control solution, the test solution and the above 5 kinds of impurity reference solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 4 times of the retention time of the aspartic acid peak. If there are chromatographic peaks with the same retention time as the main peak of the above impurity reference solution in the chromatogram of the test solution, the content of each known impurity is calculated by the peak area according to the external standard method, including maleic acid, neither fumaric acid nor arginine shall exceed 0.1%, neither shall the content of impurity I exceed 0.15% (for injection) nor (for oral preparation), and the content of impurity II shall not exceed; the Peak area of other single unknown impurities shall not be greater than the sum of the two main peak areas of the control solution (0.1% ); The total amount of impurities shall not exceed 0.5% (for injection) or 1.0% (for oral preparation).
According to the chromatographic conditions under the related substances inspection item, take the test solution under the related substances for continuous injection for 5 times, record the chromatogram, the relative standard deviation of the peak areas of aspartate and ornithine shall not be more than 2.0%. The average value of the ratio of the peak areas of aspartic acid to ornithine should be 2.61 to 3.01.
take an appropriate amount of this product, add water to dissolve and dilute to make a solution containing 5mg per lml, and add an equal volume of 30% sulfosalicylic acid solution without producing turbidity.
take 0.10g of this product and check it according to law (General rule 0801). Compared with the control solution made of 0.03% of standard sodium chloride solution, it should not be more concentrated ().
take 1.0g of this product and check it according to law (General rule 0802). Compared with the control solution made of 0.02% of standard potassium sulfate solution, it should not be more concentrated ().
take 0.10g of this product and check it according to law (General rule 0808). Compared with the control solution made of 0.04% of standard ammonium chloride solution, it shall not be deeper ().
take this product l. Log, add water 20ml to dissolve, filter, filtrate is divided into two equal parts, one part is added with the new preparation of calcium sulfate test solution lml, the other part is added with water 1ml, static for 15 minutes, both solutions should be clarified.
take this product, dry to constant weight at 120°C, weight loss shall not exceed 7.0% (General rule 0831).
This product l.O g, inspection according to law (General 0841), residue shall not exceed 0.1%.
take 0.5g of this product and check it according to law (General rule 0807). Compared with the control solution made of 0.003% of standard iron solution, it should not be deeper ().
take this product l.Og, inspection according to law (General Principles 0821 second law), including heavy gold shall not exceed 10 parts per million.
take l.Og of this product, add 23ml of water to dissolve, add 5ml of hydrochloric acid, check according to law (General rule 0822 first law), should comply with the provisions (0.0002%).
take this product about 70mg, precision weighing, add anhydrous formic acid 5ml and ice fermented acid 50ml dissolved, according to the potential titration method (General rule 0701), with perchloric acid titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 8 84mg of C5H12N202. C4H7NO4.
amino acid drugs.
sealed and stored in a dry place.