Molecular Formula | C2H5NO2 |
Molar Mass | 77.08 |
Melting Point | 240°C (dec.)(lit.) |
Solubility | Acetonitrile (Slightly), Methanol (Slightly), Water (Slightly) |
Appearance | Solid |
Color | White to Off-White |
Storage Condition | Refrigerator |
WGK Germany | 3 |
This product is glycine. The content of C2H5NO2 shall not be less than 99.0% calculated as dry product.
take L. 0g of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 5.6~6.6.
take l.Og of this product, add water 20ml to dissolve, according to ultraviolet-visible spectrophotometry (General rule 0401), measure the transmittance at 430nm wavelength, not less than 98.0%.
take l.Og of this product and check it according to law (General rule 0801). Compared with the control solution made of standard sodium chloride solution 7.0m1, it should not be more concentrated (0.007%).
take 2.5g of this product and check it according to law (General rule 0802). Compared with the control solution made of 0.006% 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 0.02% of standard ammonium chloride solution, it shall not be deeper ().
take this product, add water to dissolve and dilute to make a solution containing about 10mg per 1ml as a test solution; Take 1ml for precision measurement, put it in a 200ml measuring flask, dilute it with water to the scale, shake, as a control solution; Another appropriate amount of glycine control and alanine control, put in the same measuring flask, add water to dissolve and dilute to prepare solutions containing about 10mg and 0.05mg per 1ml, respectively, as a system suitability solution. According to the thin layer chromatography (General 0502) test, draw 2ul of each of the above three solutions, respectively point on the same silica gel G thin layer plate, with N-propanol-ammonia (7:3) as the developing solvent, about 10cm was developed, dried, dried at 80°C for 30 minutes, sprayed with ninhydrin in n-propanol solution (1-100), heated at 105°C until spots appeared, and examined immediately. The control solution should show a clear spot, and the system applicable solution should show two completely separated spots; The test solution should be in addition to the main spot., the number of impurity spots should not exceed 1, and the color should not be deeper (0.5%) compared with the main spot of the control solution.
take this product, dry at 105°C for 3 hours, loss of weight shall not exceed 0.2% (General rule 0831).
not more than 0.1% (General rule 0841).
take 1.50g 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 shall not be deeper ().
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.
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%).
take this product, check according to law (General 1143), the amount of endotoxin in each lg glycine should be less than 20EU. (For injection)
take this product about 70mg, precision weighing, add anhydrous formic acid 1.5ml to dissolve, 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 7.507mg of C2H5N02.
amino acid drugs.
light shielding, sealed storage.
This product is a sterilized aqueous solution of glycine. Glycine-containing (C2H5NO2) shall be between 95.0% and 105.0% of the labeled amount.
This product is colorless or almost colorless clear liquid.
take 10ml of this product with precision, put it in an Erlenmeyer flask, add 10ml of water and 10ml of formaldehyde solution whose pH value is adjusted to 9.0 in advance, shake well, and add mixed indicator [take phenolphthalein 75mg and Thymol Blue 25mg, add an appropriate amount of ethanol-water (1:1) to dissolve, and dilute to 100ml]5 drops, with sodium hydroxide titration solution (0.lmol/L) titration to the solution is pale purple, each lml of sodium hydroxide titration solution (0.1 mol/L) equivalent to 7.507mg of C2H5N02.
Same as glycine.
2000ml : 30g
light shielding, sealed storage.