N-(2)-L-alanyl-L-glutamine
Alanyl-glutamine
CAS: 39537-23-0
Molecular Formula: C8H15N3O4
N-(2)-L-alanyl-L-glutamine - Names and Identifiers
| Name | Alanyl-glutamine |
| Synonyms | Ala-Gln 39537-23-0 Dipeptiven Glutamine-S Alanyl-glutamine L-ALANYL-L-GLUTAMINE L-Alanyl-L-Glutamine N-(2)-L-alanyl-L-glutamine |
| CAS | 39537-23-0 |
| InChI | InChI=1/C8H15N3O4/c1-4(9)7(13)11-5(8(14)15)2-3-6(10)12/h4-5H,2-3,9H2,1H3,(H2,10,12)(H,11,13)(H,14,15) |
N-(2)-L-alanyl-L-glutamine - Physico-chemical Properties
| Molecular Formula | C8H15N3O4 |
| Density | 1.305g/cm3 |
| Melting Point | 215℃ |
| Boling Point | 615.4°C at 760 mmHg |
| Specific Rotation(α) | 10 ° (C=5, H2O) |
| Flash Point | 326°C |
| Vapor Presure | 1E-16mmHg at 25°C |
| Storage Condition | Room Temprature |
| Sensitive | Easily absorbing moisture |
| Refractive Index | 1.529 |
| MDL | MFCD00133046 |
| Use | Nutraceuticals for patients requiring glutamine supplementation |
N-(2)-L-alanyl-L-glutamine - Reference
| Reference Show more | 1. [IF=7.514] Xue Xia et al."Structural Diversity and Concentration Dependence of Pyrazine Formation: Exogenous Amino Substrates and Reaction Parameters during Thermal Processing of L-alanyl-L-glutamine Amadori Compound."FOOD CHEMISTRY. 2022 May;:133144 |
N-(2)-L-alanyl-L-glutamine - Standard
Authoritative Data Verified Data
This product is N(2)-L-alanyl-L-glutamine. Calculated as dried product, the content of C8H15N304 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
N-(2)-L-alanyl-L-glutamine - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline or crystalline powder; Odorless.
- This product is soluble in water and insoluble in ethanol, acetone or ether.
specific rotation
take this product, precision weighing, water dissolution and quantitative dilution of 50mg per lml solution, according to the law (General 0621), specific rotation of 9.5. To 11.0 °.
Last Update：2022-01-01 11:35:01
N-(2)-L-alanyl-L-glutamine - Introduction
odorless; hygroscopic. This product is soluble in water, almost insoluble or insoluble in methanol; slightly soluble in glacial acetic acid.
Last Update：2022-10-16 17:25:05
N-(2)-L-alanyl-L-glutamine - Differential diagnosis
Authoritative Data Verified Data
- take about 20mg of this product, add 1 ml of water to dissolve it, add 5 drops of ninhydrin test solution, and heat to show blue and purple color.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
Last Update：2022-01-01 11:35:01
N-(2)-L-alanyl-L-glutamine - Exam
Authoritative Data Verified Data
acidity
take this product l.Og, add water 10ml to dissolve, according to the law (General 0631),pH value should be 5.0~6.0.
clarity and color of solution
take 1.0g of this product, add 5ml of water to dissolve, the solution should be clear and colorless. If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902-method); If it is colored, it should not be deeper compared with yellow No. 1 Standard Colorimetric solution (General rule 0901 method 1).
chloride
take 0.30g of this product and check it according to law (General rule 0801). Compared with the control solution made of 6.0ml of standard sodium chloride solution, it should not be more concentrated (0.02%).
sulfate
take l.Og 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 ().
ammonium salt
take 0.10g of this product, vacuum distillation below 60°C, check according to law (General rule 0808), compared with the control solution made of 0.08% standard ammonium chloride solution, not deeper ().
Related substances
precision weighing the appropriate amount of this product, and mobile phase dissolved and diluted into each lml containing about 4mg of alanyl glutamine solution, as a test solution; the appropriate amount of each impurity reference substance was accurately weighed and dissolved and diluted with the mobile phase at the concentration shown in the table below. According to the chromatographic conditions under the content determination item, the reference solution 20u1 is injected into the liquid chromatograph, and the chromatogram is recorded. The separation degree between the impurity peaks should meet the requirements. 20 u1 of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the ring-(L-alanyl-L-glutamine) shall not exceed 0.2%, containing ring-(L-alanyl-L-glutamic acid) not more than 0.04%, containing L-pyroglutamyl-L-alanine not more than 0.15%, containing L-pyroglutamic acid not more than 0.05%, containing 1> alanyl-L-glutamine should not exceed 0.05%, containing L-alanyl-L-glutamic acid should not exceed 0.5%, other single unknown impurities according to the external standard method of alanyl-glutamine peak area calculation, not more than 0.1%, not more than 0.5% of the sum of other unknown impurities.
residual solvent
take this product about lOOmg, precision weighing, top empty bottle, precision plus 30% N,N-dimethylformamide solution 2ml to dissolve, sealed, as a test solution; accurately weigh the appropriate amount of methanol, ethanol, tetrahydrofuran and toluene respectively, and dilute with 30% N,N-dimethylformamide solution to make methanol 150ug and ethanol 250 ug per 1 ml, A solution of 36ug of tetrahydrofuran and 44.5ug of toluene was precisely weighed into 2ml, placed in a headspace bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as stationary liquid is used as the column, the initial temperature is 70°C, maintained for 2 minutes, and the temperature is increased to 120°C at a rate of 10°C per minute, and then increased to 220°C at a rate of 20°C per minute for 3 minutes; the inlet temperature was 200°C; The detector temperature was 250°C; The headspace bottle equilibrium temperature was 80°C and the equilibrium time was 20 minutes. Take the reference solution into the headspace, and the separation degree between the peaks of each component shall meet the requirements. Accurately measure the reference solution and the test solution respectively by Headspace injection, record the chromatogram, and calculate the peak area according to the external standard method. The residues of methanol, ethanol, tetrahydrofuran and toluene shall be in accordance with the regulations.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Iron Salt
take l.Og of this product and check it according to law (General rule 0807). Compared with the control solution made of 0.001% of standard iron solution, it should not be more concentrated ().
Heavy metals
take 2.0g of this product, add 23ml of water to dissolve, add 2ml of acetate buffer (pH 3.5), and check according to law (General rule 0821 first law), containing heavy metals shall not exceed 10 parts per million.
arsenic salt
take 2.0g 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 (0.0001%).
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg of alanyl glutamine should be less than 0.050EU. (For injection)
sterile
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, rinse with 0.1% sterile peptone aqueous solution (each membrane is not less than 300ml), with Staphylococcus aureus as positive control bacteria, according to law inspection (General 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:35:02
N-(2)-L-alanyl-L-glutamine - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
The mobile phase was 0.05mol/L potassium dihydrogen phosphate buffer (pH was adjusted to 4.0 with phosphoric acid)-acetonitrile (35:65), and the detection wavelength was 215nm; the flow rate was 0.7 per minute; The column temperature was 30°C. Take D-alanyl-glutamine and alanyl-glutamine control sample, the mobile phase was added to dissolve and dilute to prepare a mixed solution containing 10 tons of D-alanyl-L-glutamine and 50% of alanyl glutamine per 1 ml, and 20u1 was injected into the human liquid chromatograph to record the chromatogram. The number of theoretical plates shall not be less than 3000 based on the alanyl-glutamine peak, and the separation degree of D-alanyl-L-glutamine peak and alanyl-glutamine peak shall meet the requirements.
assay
precision weigh appropriate amount of this product, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.05mg per lml, as a test solution, take 20 u1 in precision, inject into liquid chromatograph, the chromatogram was recorded; An appropriate amount of alanyl-glutamine reference was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:35:03
N-(2)-L-alanyl-L-glutamine - Category
Authoritative Data Verified Data
amino acid drugs.
Last Update：2022-01-01 11:35:03
N-(2)-L-alanyl-L-glutamine - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:35:03
N-(2)-L-alanyl-L-glutamine - Alanyl Glutamine Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of alanyl-glutamine. Alanyl-glutamine-containing (C8H15N304) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is colorless and clear liquid.
identification
- take 1ml of this product, add 10ml of water, add 5 drops of ninhydrin test solution, and heat to show blue and purple color.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- the pH value should be 5.4 to 6.0 (General 0631).
- absorbance of this product, according to UV-visible spectrophotometry (General 0401), measured at the wavelength of 400mn, absorbance should not exceed 0.05.
- the ammonia test should be performed at 20-25°C. Take 5ml of this product with precision, put it in a 50ml measuring flask, dilute it with water to scale, shake it well, and use it as a test solution. Take 29.7mg of ammonium chloride with precision, put it in a 500ml measuring flask, an appropriate amount of water was added to dissolve and dilute to the scale, and the mixture was shaken to obtain (20ug of NH4 + per 1 ml) as a control solution. The reductase I Solution (NADH) was accurately measured (an appropriate amount of reduced coenzyme I was taken, and a solution containing 0.2mg per 1 ml of 1-oxoglutarate buffer was prepared. The solution can be stored for 3 days at 4 ° C.) 1.0ml, put in the absorption cell, add 1.9ml of test solution and ml of water, mix, react for 5 minutes. Measure the absorbance A2 at a wavelength of 340nm by UV-visible spectrophotometry (General rule 0401) with water as a reference. A human glutamate dehydrogenase solution (GLDH) was added (an appropriate amount of glutamate dehydrogenase was taken and diluted with water to make a solution containing 1000 units per 1 ml), 0.02ml was mixed, and the absorbance A2 was measured after 20 minutes. The absorbance of water and reference solution was determined by the same method, respectively, B1, B2 and C1,C2.
- Related Substances: take this product precisely and dilute it with mobile phase to make a solution containing about 4mg of alanyl-glutamine per 1 ml, which is used as the test solution; Weigh the appropriate amount of impurity reference substance precisely respectively, the control solution was prepared by dissolving and diluting the mobile phase at the concentrations shown in the following table. According to the chromatographic conditions under the content determination item, the reference solution 20u1 is injected into the liquid chromatograph, and the chromatogram is recorded. The separation degree between the impurity peaks should meet the requirements. Accurately take 20 u1 of the test solution and the reference solution, respectively inject human liquid chromatograph, record the chromatogram, if there are impurity peaks in the chromatogram of the test solution, calculate the peak area according to the external standard method, compared with the labeled amount of main component, the content of each impurity should not exceed 5.0% with ring-(L-alanyl-L-glutamine) and ring- (1 alanyl-L-glutamic acid) not more than 0.05%, containing L-pyroglutamic acid-L-alanine not more than 0.65%, containing L-pyroglutamic acid not more than 0.25%, containing D-alanyl-L-glutamine not more than 0.25%, the content of L-alanyl-L-glutamic acid shall not exceed 1.0%; Other single unknown impurities shall not exceed 0.5% based on the peak area of alanine-glutamine calculated by external standard method, and the sum of other unknown impurities shall not exceed 1.0%.
- take an appropriate amount of heavy metal (equivalent to 2.0g of alanyl glutamine), add 2ml of acetate buffer (pH 3.5), and add an appropriate amount of water to make 25ml, inspection according to law (General Principles 0821, Law 1), containing heavy metals shall not exceed 10 parts per million. The osmolality should be between 900 and 0632 mosmol/kg (general).
- bacterial endotoxin this product, according to the inspection (General 1143), the amount of endotoxin per lm l should be less than 0. 50EU.
- sterile take this product, by membrane filtration method, rinse with 0.1% sterile peptone aqueous solution (each membrane is not less than 100ml), with Staphylococcus aureus as positive control bacteria, inspection in accordance with the law (General rule 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precise amount of this product is appropriate, diluted with mobile phase to prepare a solution containing about 0.05mg of alanyl glutamine per 1 ml, and determined by the method under the item of alanyl glutamine.
category
Same as alanyl glutamine.
specification
- 50ml:10g
- l00ml:20g
storage
closed, stored in a cool place
Last Update：2022-01-01 11:35:04
N-(2)-L-alanyl-L-glutamine - Alanyl-glutamine for injection
Authoritative Data Verified Data
This product is a sterile lyophilized product or sterile powder of alanyl-glutamine. The content of alanyl glutamine (C8H15N304) shall be between 95.0% and 105.0% of the labeled amount calculated as the average loading.
trait
This product is white or off-white loose block or powder.
identification
- take about 20mg of this product, add 1 ml of water to dissolve it, add 5 drops of ninhydrin test solution, and heat to show blue and purple color.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- acidity: take 1.0g of this product, Add 10ml of water to dissolve it, and measure it according to law (General rule 0631). The pH value should be 5.4~6.0.
- the clarity of the solution: Take appropriate amount of this product and add water to make a solution containing 0.20g per lml. The solution should be clear and colorless; If it is turbid, it should be mixed with No. 1 turbidity standard solution (General rule 0902 first method). Comparison, not more concentrated.
- absorbance of this product, diluted with water to make a solution containing 0401g per lml, according to UV-visible spectrophotometry (general rule), at the wavelength of 400nm, the absorbance should not exceed 0.05.
- the ammonia test should be performed at 20-25°C. Precision weigh the appropriate amount of this product, add water to dissolve and dilute the solution containing 200mg per lml, shake, as a test solution. Weigh 29.7mg of ammonium chloride accurately, put it in a 500ml measuring flask, dissolve it with water, dilute it to the scale, shake it well, and use it as a control solution (20ug of NH4 + per 1 ml). A solution of reductase I (NADH) was precisely weighed (an appropriate amount of escoi was taken, and the solution contained in 1 ml of 2-oxoglutarate buffer was prepared. The solution can be stored for 3 days at 4 ° C.) 1.0ml, put in the absorption cell, add 1.9ml of test solution and ml of water, mix, react for 5 minutes. According to UV-visible spectrophotometry (General rule 0401), with water as reference, the absorbance A1 was measured at the wavelength of 340nm, and human glutamate dehydrogenase solution (GLDH) (take appropriate amount of cyanate dehydrogenase, the mixture was diluted with water to prepare a solution containing 1000 units per 1 ml) 0.02ml, mixed well, and the absorbance A2 was measured after 20 minutes. The absorbance of water and reference solution was determined by the same method, respectively, B1, B2 and C1,C2.
- the relevant substances are accurately weighed to take this product, and the mobile phase is added to dissolve and dilute to prepare a solution containing about 4mg of alanyl glutamine per 1 ml as the test solution; the appropriate amount of impurity reference substance was accurately weighed and dissolved and diluted with mobile phase at the concentration shown in the table below. According to the chromatographic conditions under the content determination item, 200 of the reference solution is injected into the human liquid chromatograph, and the chromatogram is recorded. The separation degree between the impurity peaks should meet the requirements. Accurately take 20 u1 of the test solution and the reference solution, respectively inject human liquid chromatograph, record the chromatogram, if there are impurity peaks in the chromatogram of the test solution, calculate the peak area according to the external standard method, compared with the labeled amount of main component, the content of each impurity should not exceed 0.5% with ring-(L-alanyl-L-glutamine) and ring-(L-alanyl-L-glutamic acid) not more than 0.04%, containing L-pyroglutamyl-L-alanine not more than 0.5%, containing L-pyroglutamic acid not more than 0.2%, containing D-alanyl-L-glutamine not more than 0.25%, the content of L-alanyl-L-glutamic acid shall not exceed 0.5%; Other single unknown impurities shall not exceed 0.5% based on the peak area of alanyl-glutamine calculated by external standard method, and the sum of other unknown impurities shall not exceed 1.0%.
- weight loss on drying this product shall be dried at 105°C to constant weight, and the weight loss shall not exceed 1.0% (sterile powder) or 3.0% (sterile lyophilized product) (General rule 0831).
- bacterial endotoxin take this product, according to the inspection (General 1143), the amount of endotoxin per lmg should be less than 0.050EU.
- sterile take this product, dissolve it in an appropriate amount of 0.1% sterile peptone aqueous solution, and then treat it by membrane filtration. Rinse it with 0.1% sterile peptone aqueous solution (each membrane is not less than 100ml), staphylococcus aureus as a positive control bacteria, according to law inspection (General 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take the content under the difference of loading amount, weigh the appropriate amount accurately, add the mobile phase to dissolve and dilute to prepare a solution containing about 0.05mg of alanyl glutamine per 1 ml, which is used as the test solution, according to the method under the item of alanyl glutamine content determination, it is obtained.
category
Same as alanyl glutamine.
specification
(l)10g (2)20g
storage
sealed and stored in a cool place.
Last Update：2022-01-01 11:35:06
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Product Name: Alu-Gln Visit Supplier Webpage Request for quotationCAS: 39537-23-0
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