外观

Appearance

 类白色或白色粉末

off-white or white powder

液相鉴别     

Hplc Identication

与对照品主峰保留时间一致

Consistent with the reference substance  main peak retention time

比旋度

Specific rotation

+20.0°-+22.0°

重金属

Heavy metals

≤ 10ppm

酸碱度

pH

7.5-8.5

干燥失重

Loss on drying

≤ 1.0%

铅

Lead

≤ 3ppm

砷

Arsenic

≤ 1ppm

镉

Cadmium

≤ 1ppm

汞

Mercury

≤ 0.1ppm

熔点

Melting Point

250.0℃-265.0℃

炽灼残渣

Residue on Ignition

≤ 0.10%

肼

Hydrazine

≤ 2ppm

松密度

Bulk density

-

振实密度

Tapped density

-

组氨酸

L-Histidine

≤ 0.3%

含量

Assay

99.0%-101.0%

需氧菌总数

Total aerobes counts

≤ 1000CFU/g

霉菌和酵母菌

Mold & Yeast

≤ 100CFU/g

大肠埃希菌

E.Coli

Negative

沙门氏菌

Salmonella

Negative