ITEMS

SPECIFICATIONS

RESULTS

Appearance

White or almost white powder

White powder

Solubility

Very soluble in water ,very sligtly soluble in ethanol (95%)

Conform

Specific Rotation

+195° ~ +203°

+198°

Identification

IR spectrum is consistant with that of reference standard

Conform

Test

pH :4.5 ~7.0

5.7

Nitrogen ≤0.01%

Conform

Colour of solution: 375nm absorbance ≤ 0.15

Conform

Residual solvents : Ethanol ≤0.05%

Conform

Loss on drying ≤ 7.0%

2.6%

Heavy Metals ≤ 5ug/g

Conform

Sulfated ash ≤ 0.3%

0.07%

Molecular weight and distribution :

The average molecular mass (Mw): 63000 ~77000

68955

Macromolecule (10%) : Mw ≤195000

185487

Micromolecule (10%) : Mw ≥13000

15845

The average molecular mass (Mn): 34000 ~48000

42094

Mw/Mn: 1.4 ~1.9

1.6

Chloride and sulfate ≤0.03%

Conform

Bacterial endotoxins  ＜0.5U/mL

Conform

Microbial contamination

TAMC ≤ 10² cfu/g

＜10cfu/g

Escherichia coli can not be detected every gram

Not detected /g

Packaging and Storage

Preserve in well-closed containers ,store at 25°;

excursions are permitted between 15°and 30°.

Conclusion

The product complies with USP40.