Asparagine is an organic compound with chemical formula CfourHeightNtwoOthree, there are D and L optical isomers, which are mainly used as drugs, and the applicable symptoms are blood pressure reduction and dilationa bronchial tube(Antiasthmatic), anti peptic ulcer and gastric dysfunction, and can also be used for microbial culture, acrylonitrile sewage treatment, etc.
It is mainly used as a medicine. Its symptoms include lowering blood pressure, dilating bronchi (relieving asthma), resisting peptic ulcer and gastric dysfunction. It can also be used formicrobial cultivation、acrylonitrile Sewage treatment, etc.
Pharmacopoeia information
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essential information
This product is asparagine monohydrate, calculated as dry product, containing CfourHeightNtwoOthreeNot less than 98.0%.
character
This product is white or almost white crystal or crystalline powder, odorless.
This product is easily soluble in hot water, almost insoluble in methanol, ethanol or ether, and easily soluble in dilute hydrochloric acid or sodium hydroxide test solution.
Specific curl
Take this product, weigh it precisely, add 3mol/L hydrochloric acid solution to dissolve it and dilute it quantitatively to make a solution containing about 20mg per 1mL. Determine according to the law (general rule 0621), and the specific rotation is+31 ° to+35 °.
identify
1. Take 1g of this product, add 5mL of 10% sodium hydroxide solution, heat it slightly to boil, the steam generated has ammonia odor and can turn the wet red litmus test paper blue.
2. Take about 1mg of this product, add 5mL of water to dissolve it, add about 5mg of ninhydrin, heat it, and the solution turns purple.
3. Take 0.1g of this sample and 0.1g of asparagine control sample, add 10mL of water respectively, dissolve them at low temperature (no more than 40 ° C), and cool them down as test solution and control 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.
inspect
Transmittance of solution
Take 0.4g 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 1.0g of this product and check it according to the law (general rule 0801). Compared with the control solution made of 5.0mL of standard sodium chloride solution, it should not be more concentrated (0.005%).
sulfate
Take 2.0g of this product, add 25mL of water, heat and dissolve it, cool it, and check according to the law (general rule 0802). Compared with the control solution made of 1.0mL of standard potassium sulfate solution, it should not be more concentrated (0.005%).
Other amino acids
Test according to thin layer chromatography (general rule 0502).
Test solution: Take 0.25g of this product, place it in a 10mL measuring flask, add appropriate amount of water, dissolve it at a low temperature (not more than 40 ° C), cool it, dilute it with water to the scale, and shake it well.
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 25mg of glutamic acid reference substance, place it in a 10mL measuring flask, add appropriate amount of water to heat it to dissolve, add 1mL of test solution, dilute it with water to the scale, and shake it evenly.
Chromatographic conditions: Silica gel G thin layer plate was used, and glacial acetic acid water n-butanol (1:1:2) was used as developing agent.
Determination method: take 5 µ L of each of the above three solutions, dab them on the same thin plate respectively, spread them for at least 10cm, dry them in the air, heat them at 110 ℃ for 15 minutes, spray 0.2% ninhydrin n-butanol-2mol/L acetic acid solution (95:5) mixed solution, heat them at 110 ℃ for about 10 minutes until the spots appear, and inspect them 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, its color shall not be deeper (0.5%) than the main spot of the control solution.
Loss on drying
Take the product and dry it at 105 ℃ for 3 hours, with weight loss of 11.5%~12.5% (general rule 0831).
Ignition residue
Not more than 0.1% (general rule 0841).
ferric salt
Take 1.0g of this product, add 25mL of water to dissolve it, and check 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%).
ammonium salt
Take 10mg of this product, put it into a weighing bottle with a diameter of about 4cm, add 1mL of water to dissolve it;Take another 1.0mL of standard ammonium chloride solution and put it into another same weighing bottle.Paste a piece of silver test paper with a side length of about 5mm wetted with 1 drop of water under the caps of two weighing bottles (immerse the filter paper strip in 0.85% sulfuric acid - 0.85% silver nitrate solution for 3-5 minutes, take it out and dry it in the air).Add 0.30g of heavy magnesium oxide into two weighing bottles respectively, immediately cover them with sealing plugs, rotate and mix them evenly, and place them at 40'C for 30 minutes.The gray color of the test paper produced by the test article shall not be deeper (0.1%) than that of the control paper made of 1.0mL of standard ammonium chloride solution.
heavy metal
Take 1.0g of this product, add 23mL of water to dissolve it, add 2mL of acetate buffer (pH 3.5), and check according to the law (General Rule 0821, Method 1). The content of heavy metals should not exceed 10 parts per million.
Arsenite
Take 2.0g of this product, add 23mL of water and 5mL of hydrochloric acid to dissolve it, and check according to the law (the first method of general rule 0822), which should meet the requirements (0.0001%).
Assay
Take about 0.15g of this product, precisely weigh it, and determine it according to the nitrogen determination method (General Rule 0704, the first method). Every 1mL of sulfuric acid titrant (0.05mol/L) is equivalent to 6.606mg of CfourHeightNtwoOthree。
