谷胱甘肽欧洲药典5.1标准

2021年2月7日发(作者：怎么治疗多囊卵巢)


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
）
1 0.0ml
，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< br>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
μ
m