ITEM

STANDARD

Appearance

A white to off-white crystalline powder.

Solubility

Slightly soluble in water,soluble in acetone, ethyl acetate and methanol

Identification

IR

UV

HPLC

Chloride and sulfate

0.02% MAX

Loss on drying

1.0% MAX

Residue on ignition

0.1% MAX

Melting range

117-120℃

Particle size

98% through 80 mesh

Total Plate Count

1000 cfu/g MAX

Yeasts & Molds

100 cfu/g MAX

E.Coli

Absent/10g

Salmonella

Absent/10g

S.aureus

Absent/10g

Ethanol

500ppm MAX

Tap density

0.45g/mL MIN

Bulk density

0.35g/mL MIN

Clarity and degree of opalescence of liquids

Clear in the 1% melatonin solution of ethanol or chloroform

Total Heavy metals

10ppm MAX

Pb

1ppm MAX

As

1ppm MAX

Hg

0.1ppm MAX

Cd

0.5ppm MAX

Individual impurity

0.1% MAX

Total impurity

1.0% MAX

Assay(on the dried basis)

98.5~101.5%