Test Items

Specification

Appearance

Slightly yellow crystal powder

Solubility

Meets the requirements

Identification

Meets the requirements

Loss on drying

≤0.20 %

Specific rotation

- 1.0～+1.0°

Melting point

60.0~～62.0℃

Residue on ignition

≤0.10 %

Heavy metals

≤ 10 ppm

Lead

≤3 ppm

Arsenic

≤ 1 ppm

Cadmium

≤ 1 ppm

Mercury

≤0.1 ppm

Limit of polymer content

Meets the requirements

Residual solvents

Ethyl acetate ≤500 ppm

Cyclohexane ≤ 3880 ppm

Toluene ≤ 20 ppm

Related substance

 Single impurity ≤0.1%

Total impurities ≤2.0%

Assay

99.0～101.0%

Total aerobic bacteria

≤1000 cfu/g

Mold&yeast

≤100 cfu/g

E.coli

Absence/g

Staphylococcus aureus

Absence/10g

Salmonella

Absence/10g

 Particle size

100% through 40 mesh

Loose bulk density

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