Test item

Specifications

Description

A white or yellowish-white crystalline powder

Identification

IR.HPLC

Appearance of solution

Clear and not ore intensely colored than reference solution BY7

Specific optical rotation

-17—-20°

Related substances

Impurity with a relative retention of 1.3 to 1.5

≤2.5%

Any other impurity(apart from the 2 rincipal peaks)

≤1.0%

The sum of all related sub.

≤5.0%

Limit of ethanol

≤5.0%

Limit of formamide

≤3.0%

Heavy metals

≤20ppm

water

≤1.0%

Sulphated ash

≤0.1%

Assay(HPLC, base on drying)

H2Bla/(H2Bla+H2Blb)≥90.0%

102.0%)≥(H2Bla+H2Bla) )≥95.0%

Noto: the assay of Bl and Bla calculated on the moisture, ethanol and formamid free bases