Alanine is an organic compound with chemical formula CthreeHsevenNOtwoAre 21 kinds of human proteinsamino acidOne, yesoptical rotation。Alanine is an important amino acid in human body, which has certain functions and effects in promoting muscle growth, enhancing immunity, promoting wound healing, etc.[5]
Solubility: soluble in water, slightly soluble in ethanol, insoluble in ether or acetone[3]
DL Alanine
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Chemical formula: CthreeHsevenNOtwo
Molecular weight: 89.093
CAS No.: 302-72-7
EINECS No.: 206-126-4
Melting point: 272-275 º C
Flash point: 82.6 ° C
Density: 1.124g/cmthree
Appearance: white crystalline powder
Solubility: easily soluble in hot water, soluble in water, slightly soluble in ethanol[1]
Pharmacopoeia information
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essential information
This product is L-2-aminopropionic acid, calculated as dry product, containing CthreeHsevenNOtwoNot less than 98.5%.
character
This product is white or almost white crystal or crystalline powder, with fragrance.
This product is soluble in water, insoluble in ethanol, acetone or ether, and soluble in 1mol/L hydrochloric acid solution.
Specific curl
Take this product, weigh it precisely, add 1mol/L hydrochloric acid solution to dissolve it and dilute it quantitatively to make a solution containing about 50mg per 1mL. Determine according to the law (general rule 0621), and the specific rotation is+14.0 ° to+15.0 °.
identify
1. Take appropriate amount of this product and alanine reference substance, add water to dissolve and dilute them respectively to prepare a solution containing about 10mg per 1mL as the test solution and reference solution.According to the method under other amino acids, the position and color of the main spot of the test solution should be the same as that of the control solution.
2. The infrared absorption spectrum of this product should be consistent with the control spectrum (spectrum set 915 figure).
inspect
acidity
Take 1.0g of this product, add 20mL of water to dissolve it, and then measure it according to the law (general rule 0631). The pH value should be 5.5~7.0.
Transmittance of solution
Take 1.0g of this product, add 20mL of water to dissolve it, and then measure the transmittance at 430nm by ultraviolet visible spectrophotometry (general rule 0401), which shall not be less than 98.0%.
chloride
Take 0.30g of this product and check it according to the 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 1.0g of this product and check it according to the law (general rule 0802). Compared with the control solution made of 2.0mL of standard potassium sulfate solution, it should not be more concentrated (0.02%).
ferric salt
Take 0.10g of this product and check it according to the law (general rule 0808). Compared with the control solution made of 2.0mL of standard ammonium chloride solution, it should not be deeper (0.02%).
Other amino acids
Test according to thin layer chromatography (general rule 0502).
Test solution: take a proper amount of this product, add water to dissolve and dilute it to make a solution containing about 25mg per 1mL.
Reference solution: precisely measure 1mL of the test solution, place it in a 200mL volumetric flask, dilute it with water to the scale, and shake it up.
System suitability solution: Take appropriate amount of alanine reference substance and glycine reference substance, place them in the same measuring flask, add water to dissolve and dilute them to make a solution containing 25 mg of alanine and 0.125 mg of glycine per 1mL respectively.
Chromatographic conditions: silica gel G thin layer plate was used, and n-butanol water glacial acetic acid (3:1:1) was used as the developing agent.
Determination method: Take 2 µ L of each of the above three solutions, dab them on the same thin plate, develop them, dry them, develop them again with the same method, and dry them.Spray 0.2% ninhydrin n-butanol glacial acetic acid solution [n-butanol-2mol/L glacial acetic acid solution (95:5)], heat at 105 ℃ until spots appear, and inspect immediately.
System suitability requirements: the reference solution should show a clear spot, and the system suitability solution should show two completely separated spots.
Limit: if the test solution shows impurity spots, there should be no more than one, and its color should not be deeper (0.5%) than the main spot of the control solution.
Loss on drying
Take this product and dry it at 105 ℃ for 3 hours. The weight loss shall not exceed 0.2% (general rule 0831).
Ignition residue
Not more than 0.1% (general rule 0841).
ferric salt
Take 1.0g of this product and check it according to the law (general rule 0807). Compared with the control solution made of 1.0mL of standard iron solution, it should not be deeper (0.001%).
heavy metal
Take 2.0g of this product, add 23mL of water to dissolve it, add 2mL of acetate buffer solution (pH 3.5), and check according to the law (General Rule 0821, Method 1). The content of heavy metals should not exceed 10% per million.
Arsenite
Take 2.0g of this product, add 23mL of water to dissolve it, add 5mL of hydrochloric acid, and check according to the law (the first method of general rule 0822), which should meet the requirements (0.0001%).
Bacterial endotoxin
Take this product and check it according to the law (general rule 1143). The amount of endotoxin in every 1g of alanine should be less than 20EU.(for injection)
Assay
Take about 80mg of this product, precisely weigh it, add 2mL of anhydrous formic acid to dissolve it, add 50mL of glacial acetic acid, titrate it with perchloric acid titrant (0.1mol/L) according to the potentiometric titration method (General Rule 0701), and correct the titration result with a blank test.Every 1mL perchloric acid titrant (0.1mol/L) is equivalent to 8.909mg CthreeHsevenNOtwo。
