Subjects

Specifications

Characters

Appearance

White powder

Solubility

Easily soluble in water, Soluble in Acetone, practically insoluble in Ether

Clarity of solution

Clear solution(100mg/10ml water)

Identification:

A.IR

IR Spectrum of the sample corresponds

to that of the ref. standard

B.HPLC

The retention time of the major peak in the chromatograms corresponds to that in the reference standard

C. Tartrate Reaction

Positive for Tartrate

Test

PH

3.3～3.8

Water

NMT4.0%

Color of Solution

Absorbance at 420nm:NMT0.03(1%w/v solution in water)

Residue on ignition

NMT 0.1%

Related compounds

A: Photo-degradation

NMT 0.3%

B: Individual impurity

NMT 0.2%

C: Total impurities

NMT 0.7%

Residual Organic solvent

A. Chloroform

NMT 0.006%

B. Methylene Chloride:

NMT 0.06%

C.  Acetone

NMT 0.5%

D. Ether

NMT 0.5%

E: Methanol

NMT 0.3%

Microbiological purity(bacterias and mould)

NMT 100CFU/g

Enterobacteriaceae

Not detected

Pseudomonas aeruginosa

Not detected

Staphylococcus aureus

Not detected

Chromatographic purity (HPLC)

NLT99.0%(HPLC)

Assay(HPLC)

98.0～102.0%