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L-Proline traits examination

L-Proline traits examination
Determination of acidity: Take 2.0g, dissolved in 20ml water, according to the determination, pH value should be 5.9 to 6.9.

Solution transmittance measurement: Take 1.0g, dissolved in 10ml of water, according to spectrophotometry, was measured at 430nm wavelength transmittance of not less than 98.0%.

Chloride test: Take 0.25g, according to inspection, with the standard sodium chloride solution made from the control solution 5.0ml more, not thicker (0.02%).

Sulfate test: Take 1.0g, according to the law examination, and standard potassium sulfate solution 2.0ml control solution made more, not thicker (0.02%). Ammonium salt of this product 0.1g, according to inspection, with the standard ammonium chloride solution, 2.0ml liquid were made more, not deeper (0.02%).

Other amino acid test: Take this product, made with water containing 50mg per 1ml of the solution, as the test solution; precise amount of amount, diluted with water containing 0.25mg per 1ml of the solution, as the control solution. According to thin layer chromatography test, drawing the two solutions of 2μl, respectively, points on the same silica gel G plate, n-butanol - ethanol - concentrated ammonia solution - water (8:8:1:3) as agent, started later, dried, sprayed with ninhydrin solution in acetone (1 → 50), dried at 80 ℃ for about 10 minutes, and immediately view the test solution are significant impurities spot color, and the main control solution spots more, shall not be deeper (0.5%). Drying of this product, dried at 105 ℃ 3 hours, not less than 0.3% weight loss.

Residue on ignition: not over 0.1%.

Ferric test: Take 1.0g, according to inspection, with the standard iron solution made from the control solution more 1.0ml, not deeper (0.001%). Heavy metals to take this product 1.0g, dissolved in 23ml water, vinegar salt buffer (pH3.5) 2ml, according to inspection, shall not contain heavy metals than ten millionths.

Arsenic test: Take 2.0g, 5ml hydrochloric acid dissolved in 23ml of water, according to inspection (Appendix Ⅷ J first law), shall meet the requirements (0.0001%).

Pyrogen test: to take this product, add sodium chloride injection containing 45mg per 1ml of the solution, according to inspection (Appendix Ⅺ D), 1kg of body weight per dose in rabbits by injecting 10ml, should meet the requirements (for injection) .

This product pyrrolidine 2 - carboxylic acid. Calculated on dry goods, including C5H9NO2 not less than 98.5%.

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