檢驗項目

Tests

標準規定

Specifications

外  觀

Description

白色或類白色結晶性粉末

A white or almost white powder

鑒  別

Identification

液相色譜圖中，本品主峰的保留時間與對照品一致。

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 顏 色

Color of solution

≤黃色、黃綠色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°

濁  度

Turbidity

≤1號濁度標準液

The turbidity is Less than or equal to 1^#

細菌內毒素

Bacterial endotoxin

≤0.10EU/mg

Less than or equal to 0.10EU/mg

主峰后第一單雜

The first impurity peak

≤0.70%

Less than or equal to 0.70%

其他雜質

Other impurity

≤0.40%

Less than or equal to 0.40%

雜質總和

Total impurity

≤2.0%

Less than or equal to 2.0%.

含  量

Assay

按無水物計算，含頭孢西丁酸≥98.5%

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