Appearance

White to slightly yellow crystalline powder

White crystalline powder

Identification

Positive

Positive

Clarity of solution

Clear, ≤BY6

Clear

Assay

99.0%-101.0%

99.7%

Loss on drying

≤0.25%

0.05%

Sulphate

≤150ppm

<150ppm

Specific rotation

+103°～+106°

+105.9°

PH (10%, W/V)

7.0-8.0

7.9

Residual solvents (as Methanol)

≤3000ppm

<3000ppm

Heavy metals (as Pb )

≤3ppm

<3ppm

Iron

≤2ppm

<2ppm

Copper

≤2ppm

<2ppm

Impurity E

≤0.3%

<0.3%

Arsenic

≤3ppm

<3ppm

Lead

≤2ppm

<2ppm

Nickel

≤1ppm

<1ppm

Mercury

≤1ppm

<1ppm

Related substances

Impurity C≤0.15%

Impurity D≤0.15%

other unspecific impurities≤0.10%

Total impurity≤0.2%

Complies

Total plate count

≤1000cfu/g

<1000cfu/g