Appearance

White crystalline powder

White crystalline powder

Identification

Positive

Positive

Clarity of solution

Clear

Clear

Color of solution

≤BY7

≤BY7

Assay

99.0%-100.5%

99.7%

Loss on drying

≤0.4%

0.04%

Residue on ignition

≤0.1%

0.04%

Sulphate ash

≤0.1%

0.04%

Specific rotation

+20.5°～+21.5°

+20.92°

PH (with 2% water solution)

2.4-2.8

2.54

PH (with 5% water solution)

2.1-2.6

2.32

Melting range

About 190℃

191℃

Heavy metals

≤3ppm

<3ppm

Iron

≤2ppm

<2ppm

Copper

≤2ppm

<2ppm

Impurity E

≤0.2%

<0.2%

Arsenic

≤1ppm

<1ppm

Lead

≤2ppm

<2ppm

Cadmium

≤1ppm

<1ppm

Mercury

≤1ppm

<1ppm

Organic volatile impurities

Meets the requirements

Conform

Related substances

Impurity C≤0.15%

Impurity D≤0.15%

Any other unspecific impurities≤0.10%

Total impurity≤0.2%

Complies

Total plate count

≤1000cfu/g

<1000cfu/g