埃索美拉唑镁

产品名称Product name

埃索美拉唑镁(C₃₄H₃₆MgN₆O₆S₂•3H₂O)

Esomeprazole magnesium

批号batch No.

18010301

生产日期 Mfg. date

2018-01-03

有效期至 Exp. date

2020-01-02

检验项目Tests

标准规定Specifications

检验结果Results

性    状

Description

白色至微黄色的粉末

White to slightly colored powder

符合规定

Conforms

溶解于甲醇，微溶于水，几乎不溶于庚烷。

Dissolved in methanol, slightly soluble in water, almost insoluble in heptane.

符合规定 

Conforms

鉴    别

IdentifIcation

(A)红外图谱应与对照图谱一致

Sample spectrum should match with working standard.

符合规定

 Conforms

(B)原子吸收谱线应与标准品一致

Absorption maximum of sample should match with standard

符合规定

 Conforms

       溶液颜色

Appearance of solution

在440nm，吸光度≤0.2。

符合规定

 Conforms

    水    分 Water

6.0%～8.0%

7.32%

有关物质

Related Substances

奥美拉唑N-氧化物≤0.1%

OmeprazoleN-oxide≤0.1%

奥美拉唑磺酰化合物≤0.2%

Omeprazole sulfonamide compounds≤0.2%

任意其他单杂≤0.1%

Other unknown monohetero 0.1%

总杂质≤0.5%  Total impurities≤0.5%

0.01%

0.02%

0.05%

0.18%

   对映体纯度

Enantiomeric Purity

R对映体≤0.2%

Enantiomeric ≤0.2%

0.05%

镁含量Magnesium Content

3.30%～3.55%

3.54%

残留溶剂

Limit of residual solvents

二氯甲烷≤0.06% Dichloromethane≤0.06%

0.011%

甲醇≤0.3%  Methanol≤0.3%

0.004%

丙酮≤0.5% Acetone≤0.5%

0.005%

乙酸乙酯≤0.5% Ethyl acetate≤0.5%

0.004%

甲苯≤0.089% Toluene≤0.089%

0.002%

含量

98.0%～102.0%

98.52%

结论：                              符合USP40标准 Conforms to USP40