谷胱甘肽欧洲药典5.1标准

GLUTATHIONE

Glutathionum

C10H17N3O6S Mr 307.3

DEFINITION

L-?-Glutamyl-L-cysteinylglycine.

Content : 98.0 per cent to 101.0 per cent (dried substance).

谷胱甘肽

C10H17N3O6S Mr 307.3

定义描述

L－r谷氨酰基－L－半胱氨酰基甘氨酸

含量：按干燥品计算，98.0%-101.0%

CHARACTERS

Appearance: white or almost white, crystalline powder or

colourless crystals.

Solubility : freely soluble in water, very slightly soluble in

ethanol (96 per cent) and in methylene chloride.

性状

外观性状：白色或几乎白色结晶性粉末或无色的结晶。

溶解度：易溶于水，微溶于96%乙醇及二氯甲烷。

IDENTIFICATION

A. It complies with the test for specific optical rotation (see

Tests).

B. Infrared absorption spectrophotometry (2.2.24).

Comparison : glutathione CRS.

鉴别

A 比旋度符合特定的光学旋转测定（见测定项）。

B 红外吸收光谱检测（2.2.24）

对比：谷胱甘肽CRS.

TESTS

Solution S. Dissolve 5.0 g in distilled water R and dilute to 50 ml with the same solvent. Appearance of solution. Solution S is clear (2.2.1) and colourless (2.2.2, Method II).

Specific optical rotation (2.2.7) : ?15.5 to ?17.5 (dried substance).

Dissolve 1.0 g in water R and dilute to 25.0 ml with the same solvent.

测定

溶液S：取本品5.0g，蒸馏水R溶解并稀释至50ml。

溶液澄清度溶液S澄清(2.2.1)，无色(2.2.2, Method II)

比旋度（2.2.7) －15.5。～－17.5°（干品物质）

取本品1.0g，蒸馏水R溶解并稀释至25.0ml。

Related substances. Capillary electrophoresis (2.2.47).

Prepare the solutions immediately before use.

Internal standard solution (a). Dissolve 0.100 g of phenylalanine R in the electrolyte solution and dilute to 50.0 ml with the same solution.

Internal standard solution (b). Dilute 10.0 ml of internal standard solution (a) to 100.0 ml with the electrolyte solution.

Test solution (a). Dissolve 0.200 g of the substance to be examined in the electrolyte solution and dilute to 10.0 ml with the same solution.

Test solution (b). Dissolve 0.200 g of the substance to be examined in internal standard solution (b) and dilute to 10.0 ml with the same solution.

Reference solution (a). Dissolve 20 mg of the substance to be examined in internal standard solution (a) and dilute to 10.0 ml with the same solution.

Reference solution (b). Dilute 5.0 ml of reference solution (a) to 50.0 ml with the electrolyte solution.

Reference solution (c). Dissolve 0.200 g of the substance to be examined in 5 ml of the electrolyte solution. Add 1.0 ml of internal standard solution (a), 0.5 ml of a 2 mg/ml solution of L-cysteine R (impurity B) in the electrolyte solution, 0.5 ml of a 2 mg/ml solution of L-glutathione, oxidised R (impurity C) in the electrolyte solution and 0.5 ml of a 2 mg/ml solution of L-?-glutamyl-L-cysteine R (impurity D) in the electrolyte solution. Dilute to 10.0 ml with the electrolyte solution.

有关物质采用毛细管电泳法（2.2.47）

溶液应临用前新鲜配制

内标液（a）取苯丙氨酸0.100g，加电解质溶液溶解并稀释至50.0ml

内标溶液（b）量取内标溶液（a）10.0ml，用电解质溶液稀释至100.0ml

供试溶液（a）取待检物质0.200g，加电解质溶液溶解并稀释至10.0ml。

供试溶液（b）取待检物质0.200g，加溶液(b)溶解并稀释至10.0ml

对照溶液（a）取待检物质20g，加标准溶液（a）溶解并稀释至10.0ml

对照溶液（b）取对照溶液（a）5.0ml，加电解质溶液稀释至50.0ml

对照溶液(c) 取待检物质0.200g，加电解质溶液5ml溶解，加入1.0ml对照溶液（a），0.5ml2mg/ml L -半胱氨酸R的电解质溶液（杂质B），0.5ml2mg/ml氧化型谷胱甘肽R电解质溶液（杂质C）及0.5ml2mg/mlL－r谷氨酰基－L－半胱氨酰基甘氨酸R的电解质溶液（杂质D），然后用电解质溶液稀释至10.0ml

Capillary:

- material: uncoated fused silica,

- size: length to the detector cell = 0.5 m; total

length = 0.6 m; ? = 75 μm.

Temperature: 25 °C.

Electrolyte solution. Dissolve 1.50 g of anhydrous sodium dihy drogen phosphate R in 230.0 ml of water R and adjust to pH 1.80 with phosphoric acid R. Dilute to 250.0 ml with water R. Check the pH and, if necessary, adjust with phosphoric acid R or dilute sodium hydroxide solution R. Detection: spectrophotometer at 200 nm.

Preconditioning of a new capillary: rinse the new capillary before the first injection with 0.1 M hydrochloric acid for 20 min at 138 kPa and with water R at 138 kPa for 10 min ; for complete equilibration, condition the capillary with the electrolyte solution for 40 min at 350 kPa, and subsequently for 60 min at a voltage of 20 kV;

毛细管

-材料：石英（未涂层）

-尺寸：有效长度0.5m，总长：0.6m，内径75 μm