Appearance

White or off-white powder

Solubility

Sparingly soluble in MeOH, soluble in water and 1%acetate acid  

HPLC

The principal peak in the chromatogram obtained with the ion test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution

Amino acid analysis

Arg     0.9-1.1

Ala     0.9-1.1

His    0.9-1.1

Leu    0.9-1.0

Pro     0.8-1.0

Tyr    0.9-1.1

Glu   0.9-1.1

Ser    0.7-1.0

No more than the traces of the other amino acid are present

MS

1167.3±1.0

Related Substances

Unspecified impurity

For each impurity: NMT 1.0%

Total impurity:NMT2.0%

Acetic acid

NMT 12.0%

Water

NMT 5.0%

Specific Optical Rotation

-46.0°to-56.0°

(anhydrous and acetic acid free substance)

Baceterial endotoxins

Less than16.7IU/mg

Residual solvent

Methanol

NMT 3000ppm

Acetonitrile

NMT 410ppm

Triethylamine

NMT 320ppm

Assay

97.0%-103.0%