检验项目

Tests

标准规定

Specifications

外  观

Description

白色或类白色结晶性粉末

A white or almost white powder

鉴  别

Identification

液相色谱图中，本品主峰的保留时间与对照品一致。

The retention time of sample corresponds to the retention time of Cefoxitin acid WRS in the assay.

酸  度

Acidity（pH）

2.5-3.5

透光率

Transmittance（600nm）

≥98.5%

Great than or equal to 98.5%

吸收值

Absorption value （400nm）

≤0.05

Less than or equal to 0.05

溶 液 的 颜 色

Color of solution

≤黄色、黄绿色3^#

The solution is Less than or equal to Y、YG 3^#

水  分

Water

≤4.5%

Less than or equal to 4.5%.

比 旋 度

Curl

+195°- +208°

浊  度

Turbidity

≤1号浊度标准液

The turbidity is Less than or equal to 1^#

细菌内毒素

Bacterial endotoxin

≤0.10EU/mg

Less than or equal to 0.10EU/mg

主峰后第一单杂

The first impurity peak

≤0.70%

Less than or equal to 0.70%

其他杂质

Other impurity

≤0.40%

Less than or equal to 0.40%

杂质总和

Total impurity

≤2.0%

Less than or equal to 2.0%.

含  量

Assay

按无水物计算，含头孢西丁酸≥98.5%

Great than or equal to 98.5% cefoxitin on the anhydrous basis.