2,5-Diamino-5-oxopentanoic acid - Names and Identifiers
Name | Glutamine
|
Synonyms | D,L-Gln Glutamine DL-GLUTAMINE glutaminic acid DL-Glutamine hydrate 2-Aminoglutaramic acid Pomalidomide Impurity 4 Pomalidomide Impurity 12 DL-2-Aminoglutaramidic acid (±)-2-Aminoglutaramidic acid 2,5-Diamino-5-oxopentanoic acid 2-amino-4-carbamoylbutanoic acid 2,5-diamino-5-oxo-pentanoic acid
|
CAS | 585-21-7
|
EINECS | 1308068-626-2 |
InChI | InChI=1/C5H10N2O3/c6-3(5(9)10)1-2-4(7)8/h3H,1-2,6H2,(H2,7,8)(H,9,10) |
2,5-Diamino-5-oxopentanoic acid - Physico-chemical Properties
Molecular Formula | C5H10N2O3
|
Molar Mass | 146.14 |
Melting Point | 185-186° (King); mp 173-174.5° (Kline) |
Solubility | Aqueous Acid (Slightly), Water (Slightly, Sonicated) |
Appearance | White crystal |
Color | White to Off-White |
Merck | 4471 |
Storage Condition | Refrigerator |
MDL | MFCD00065103 |
2,5-Diamino-5-oxopentanoic acid - Standard
Authoritative Data Verified Data
This product is L-2-aminopentanoic acid. Calculated as dried product, containing no less than 99.0% of C5H10N203.
Last Update:2024-01-02 23:10:35
2,5-Diamino-5-oxopentanoic acid - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; Odorless.
- This product is dissolved in water, almost insoluble in ethanol or ether.
specific rotation
take this product, precision weighing, add appropriate amount of water, dissolve in 40°C water bath, cool, dilute quantitatively with water to make a solution containing about 40mg per 1 ml, measured according to law (General rule 0621), the specific rotation is 6.3 ° to 7.3 °.
Last Update:2022-01-01 11:58:26
2,5-Diamino-5-oxopentanoic acid - Differential diagnosis
Authoritative Data Verified Data
- take the product of aqueous solution (1-50)5ml, add 5 drops of dilute hydrochloric acid and sodium nitrite solution 1ml, should foam.
- take 5ml of aqueous solution (1-1000) of this product, add 1 ml of ninhydrin solution, and heat for 3 minutes, and the solution will appear purple.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 895).
- appropriate amounts of this product and the glutamine reference product were dissolved in water and diluted to prepare a solution containing about 2.5mg per 1 ml as the test solution and the reference solution. According to the chromatographic conditions under the relevant substances, 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.
Last Update:2022-01-01 11:58:27
2,5-Diamino-5-oxopentanoic acid - Exam
Authoritative Data Verified Data
acidity
take this product, add water to dissolve and dilute the solution containing 20mg per lml, according to the law (General 0631) , pH value should be 4.8~5.8.
transmittance of solution
take this product, dissolve and dilute with water to make a solution containing 25mg per lml, and measure the transmittance at 430nm by UV-visible spectrophotometry (General rule 0401), not less than 98.0%.
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 gasification sodium solution, it should not be more concentrated (0.02%).
sulfate
take 0.70g 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 0.10% of standard ammonium chloride solution, not deeper ().
Related substances
take an appropriate amount of this product, accurately weigh, add water to dissolve and quantitatively dilute to make a solution containing about 2.5mg per lml, as a test solution; Precision weigh the glutamine reference substance, an appropriate amount of each of the glutamic acid control and pyroglutamic acid control was placed in the same measuring flask, and water was added to dissolve and quantitatively dilute to prepare a mixed solution each containing about 12.5ug per 1 ml as a reference solution. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as filler; Sodium octane sulfonate solution (0.865g of sodium octane sulfonate was dissolved by adding 0.5 of water, of phosphoric acid was added and mixed uniformly)-Acetonitrile (95:5) as mobile phase; The detection wavelength was 210Nm. 100 of the reference solution is injected into the human liquid chromatograph, and the chromatographic system is adjusted. The pyroglutamic acid peak, glutamine peak and glutamic acid peak are sequentially released, and the separation degree between peaks shall meet the requirements. The LOLs of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the glutamine peak. In the chromatogram of the test solution, if there are any chromatographic peaks with the same retention time of pyroglutamic acid peak and glutamic acid peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and neither pyroglutamic acid nor glutamic acid shall exceed 0.5%.; Other single impurities shall be calculated based on the glutamine peak area in the chromatogram of the reference solution, and shall not exceed 0.5%, and the sum of other impurities shall not exceed 1.0%. Peaks in the chromatogram of the test solution that were 0.1 times smaller than the area of the glutamine peak in the control solution were ignored.
loss on drying
take this product, dry at 105°C for 3 hours, loss of weight shall not exceed 0.30% (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 1.0 ml of standard iron solution, it shall not be deeper (0.001%).
Heavy metals
take l.Og 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 not more than 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%).
pyrogen
This product is dissolved and diluted with sodium chloride injection to make a solution containing 10mg per 1 ml. The pH value is adjusted to 7 with sodium hydroxide solution and checked according to law (General rule 1142), dose according to the rabbit body weight every 1kg injection 10ml, should meet the requirements. (For injection)
Last Update:2022-01-01 11:58:28
2,5-Diamino-5-oxopentanoic acid - Content determination
Authoritative Data Verified Data
take this product about 0.12g, precision weighing, add anhydrous formic acid 3ml dissolved, add glacial acetic acid 50ml, 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 14.61mg of C5H10N2O3.
Last Update:2022-01-01 11:58:28
2,5-Diamino-5-oxopentanoic acid - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:58:28
2,5-Diamino-5-oxopentanoic acid - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 11:58:28
2,5-Diamino-5-oxopentanoic acid - Glutamine Capsules
Authoritative Data Verified Data
This product contains glutamine (C5H10N203) should be labeled the amount of 90.0% to 110.0%.
trait
The content of this product is white or white particles.
identification
- take an appropriate amount of the content of this product (about equivalent to 1g of glutamine), add 50ml of water, dissolve and filter, take 5ml of filtrate, add 5 drops of dilute hydrochloric acid and 1 ml of sodium nitrite solution, and foam.
- take an appropriate amount of the content of this product (about equivalent to glutamine O.lg), add 100ml of water, dissolve, filter, take 5ml of filtrate, add 1ml of ninhydrin test solution, heat for 3 minutes, the solution shows purple color.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the swab solution should be consistent with the retention time of the main peak of the reference solution.
examination
- the contents under the item of difference in loading amount of related substances should be mixed uniformly, and the appropriate amount (equivalent to 250mg of glutamine) should be accurately weighed, water was added to dissolve and quantitatively diluted to prepare a solution containing about 2.5mg of glutamine per 1 ml, filtered, and the filtrate was taken as a test solution. According to the method under the item of glutamine related substances, the inspection shall be in accordance with the provisions of D
- loss on drying: take an appropriate amount of the contents of this product, dry to constant weight at 105°C, and lose no more than 0.4% of the weight (General rule 0831).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), water 500ml as the dissolution medium, the speed of 50 rpm, according to the law, after 30 minutes, the appropriate amount of the solution was filtered, and the filtrate was taken as the test solution, water was added to dissolve and quantitatively diluted to prepare a solution containing about 0.5mg per 1 ml as a control solution. 20 u1 of each of the test solution and the reference solution are accurately measured, and the dissolution amount of each particle is calculated according to the method under the content determination item. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Sodium octane sulfonate solution (0.865g of sodium octane sulfonate, dissolved in 1000ml of water, phosphoric acid 0.5mK mixed with acetonitrile (95:5) mobile phase; The detection wavelength was 2 l0mn. Take 50mg of the content of this product, add water to dissolve and dilute to 10ml, put water bath heating for 20 minutes, filter, take the filtrate as the system applicable solution, take 20u1 injection human liquid chromatograph, record the chromatogram, the degree of separation of glutamine peak and adjacent impurity peak shall meet the requirements.
- determination of content under the item of loading difference, mixing, fine, precision weighing appropriate amount, dissolved and diluted with water to make a solution containing about 0.5mg of glutamine per 1 ml, filtering, the continued filtrate was taken as the test solution. 20u1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. The appropriate amount of glutamine reference substance was weighed accurately, dissolved with water and quantitatively diluted to make a solution containing about 0.5mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as glutamine.
specification
0.25g
storage
light shielding, sealed storage.
Last Update:2022-01-01 11:58:29
2,5-Diamino-5-oxopentanoic acid - Glutamine granules
Authoritative Data Verified Data
This product contains glutamine (C5H10N203) should be labeled the amount of 90.0% to 110.0%.
trait
This product is white or white particles.
identification
- take an appropriate amount of this product (about equivalent to lg of glutamine), add 50ml of water, dissolve with slight heat, filter, take 5ml of filtrate, add 5 drops of dilute hydrochloric acid and 1ml of Sodium Nitrite test solution, and foam.
- take an appropriate amount of this product (about equivalent to 0.lg of glutamine), add 100ml of water, dissolve with slight heat, filter, take 5ml of filtrate, add 1ml of ninhydrin test solution, heat for 3 minutes, and the solution should be purple.
- 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 contents under the item of difference in loading amount of related substances shall be uniformly mixed, and the appropriate amount (equivalent to 250mg of glutamine) shall be accurately weighed, water was added to dissolve and quantitatively diluted to prepare a solution containing about 2.5mg of glutamine per 1 ml, filtered, and the filtrate was taken as a test solution. The appropriate amounts of hydroxypropyl methylcellulose and dextrin were taken, dissolved by adding water and diluted to prepare a solution containing about 0.2mg each in 1 ml, filtered, and the continued filtrate was taken as an auxiliary control solution. According to the method under the item of glutamine related substances, in addition to the peak of the auxiliary material, it should be in accordance with the provisions.
- weight loss on drying this product shall be dried at 80°C under reduced pressure to constant weight, and the weight loss shall not exceed 2.0% (General rule 0831).
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Sodium octane sulfonate solution (take 0.865g of sodium octane sulfonate, add 0.5 of water to dissolve, add of phosphoric acid, mix well)-Acetonitrile (95:5) as mobile phase; The detection wavelength was 2 l0mn. Take 50mg of this product, add water to dissolve and dilute to 10ml, put water bath heating for 20 minutes, filter, take 20u1 injection human liquid chromatography, adjust the chromatographic system, glutamine peak and adjacent impurity peak separation should meet the requirements.
- determination of content under the item of loading difference, mixed evenly, precision weighing appropriate amount (equivalent to about 250mg of glutamine), add water to dissolve and dilute to make a solution containing about 0.5mg of glutamine per 1 ml, filter, take the filtrate as a test solution, take 20 u1 with precision, inject human liquid chromatograph, record the chromatogram; in addition, an appropriate amount of glutamine reference substance was accurately weighed, dissolved with water and quantitatively diluted to make a solution containing about 0.5mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as glutamine.
specification
(1)1.Og (2)2.5g
storage
It should be kept sealed in a cool place.
Last Update:2022-01-01 11:58:30