Molecular Formula: C3H7NO2S.HCl.H2O
Molecular Weight: 175.64
Quality Standards: USP28, AJI92.
Recommended limit:1 year.
Characteristics: White crystals or crystalline powder, strongly acid taste. Freely soluble in water. Soluble in ethanol, practically insoluble in ether.It can be used for injection, food additives, health care, cosmetics and sports nutrition,etc.
Chemical Formula
C3H7NO2S HCl H2O
Molecular Weight
175.64
[Compositional Specifications of L-Cysteine Monohydrochloride]
Content
After drying, L-Cystein Monohydrochloride contains 98.0~102.0% of L-cysteine monohydrochloride (C3H7NO2S · HCl=157.62).
Description
L-Cystein Monohydrochloride occurs as colorless to white crystals or as a white crystalline powder, having a characteristic odor and taste.
Identification
(1) To 5 ml of L-Cysteine Monohydrochloride solution (1→1,000), add 0.5 ml of pyridine and 1 ml of ninhydrin solution (1→100), and heat for 5 minutes. A purple to purple-brown color develops.
(2) To 10 ml of an aqueous solution of L-Cystein Monohydrochloride (1→1,000), add 2 ml of sodium hydroxide solution and 2 drops of sodium nitroprusside solution. A purple-red color develops.
(3) To 10 ml of L-Cysteine Monohydrochloride solution (1→50), add 1 ml of hydrogen peroxide, and heat in a water bath for 10 minutes. The solution respond to the test for Chloride (2).
Purity
(1) Clarity of Solution : When 1 g of L-Cystein Monohydrochloride is dissolved in 20 ml of water, the solution should be colorless and clear.
(2) Specific rotation : Approximately 4 g of L-Cystein Monohydrochloride is precisely weighed, which is dissolved in 1 N hydrochloric acid so that the total volume becomes 50 ml. Optical rotation of the solution is measured. When it is translated to dried material, α(20, D) = +5.0∼+8.0°.
(3) Arsenic : 0.5 g of L-Cystein Monohydrochloride is placed in a 100 ml flask for decomposition. After adding 5 ml of sulfuric acid and 5 ml of nitric acid, the flask is slowly heated. 2~3 ml of nitric acid is added at a time and the flask is heated until the liquid becomes colorless~pale yellow. After cooling, 15 ml of saturated ammonium hydroxide is added to the flask, which is then heated and concentrated to 2~3 ml until white smoke is generated. After cooling, water is added to bring the total volume to 10 ml. 5 ml of the resulting solution is tested for arsenic. The content should not be more than 4ppm. A color standard is prepared by repeating the same procedure with 2 ml of arsenic standard solution in a decomposition flask.
(4) Heavy metals : The residues after thermogravimetric analysis are dissolved in 1 ml of hydrochloric acid and 0.2 ml of nitric acid. This solution is evaporated to dryness in a water bath. It is gain dissolved in 1 ml of dilute hydrochloric acid and 15 ml of water by heating. After cooling, 1 drop of phenolphthalein solution is added and ammonia solution is drop-wise added until the solution turns pale red. 2 ml of dilute acetic acid is added to the resulting solution, Test Solution. This Test Solution is tested for heavy metals and its content should not be more than 20ppm.
(5) Cystine : Weigh 100 mg of L-Cysteine Monohydrochloride, dissolve in 50 ml of N-ethylmaleimide solution (1>50), and allow to stand for 2 hours. Use this solution as the test solution. Measure 5 ul the test solution, perform Paper Chromatography using an n-butyl alcohol, water, glacial acetic acid mixture (5:2:1) as the developing solvent. Only one spot should be observed. For the filter paper, use a No. 2 filter paper for chromatography. Stop the development when the developing solvent front rises about 30 cm. Air-dry, then dry at 100° for 20 minutes, spray with a solution of ninhydrin saturated n-butyl alcohol (1→500), and heat at 100° for 5 minutes to develop a color. Observe under natural light. Reference solution is not used.
Loss on Drying
L-Cystein Monohydrochloride is dried for 24 hours in a vacuum desiccator (silica gel) and the weight loss should be 8∼12%.
Residue on Ignition
When thermogravimetric analysis is done with L-Cystein Monohydrochloride 1 g in a quartz or porcelain crucible, the amount of residues should be 0.1% or lower.
Assay
Weigh accurately about 0.25 g of L-Cysteine Monohydrochloride, dissolve in 20 ml of water, and add 4 g of potassium iodide to dissolve in this solution. To this solution, add 5 ml of diluted hydrochloric acid and 25 ml of 0.1 N iodine, and allow to stand in ice water for 20 minutes in a dark place. Titrate the excess iodine with 0.1 N sodium thiosulfate solution (indicator: starch solution). Separately, perform a blank test by the same procedure.
0.1 N iodine 1 ml = 15.76 mg of C3H7NO2S · HCI
Permitted Use Level of L-Cysteifle Monohydrochloride and Ingredients Containing it
L-Cystein Monohydrochloride should only be used for the following food items.
1. Wheat flour
2. Fruit juice
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