Appearance

 White or off-white powder

Specific Rotation

+28°~+34°

Identification

1. HPLC: The retention time of principal peak in the chromatogram of the Test Solution corresponds to that of the Reference Solution in Assay

2. IR: The spectrum of the sample corresponds to that of reference solution

pH

2.1～2.5

Clarity and color of

solution

Clarity ≤1# Turbidity Standard

Color ≤2# Yellow Standard

（S,S）Isomers

≥65%

Related substances（%）

Adenine≤0.5%

S- Adenosyl-L-Homocysteine ≤0.5%

Methylthioadenosine ≤2.0%

Impurity A ≤1.5%

Impurity B ≤0.5%

RRT≈1.65 ≤0.2%

Any other impurity ≤0.1%

Total impurities ≤3.0%

Water

≤3.0%

Residues on ignition

≤0.5%

Heavy metals

≤10ppm

Microbial limit tests

TAMC≤103cfu/g

TYMC≤102cfu/g

E. coli should not be detected per gram

Bacterial Endotoxin

≤0.25EU/mg

Assay (calculated on

anhydrous basis)

1,4-Butanedisulfonic Acid: 46.0～52.0%

Adenosine methionine: 48.0～54.0%

Standard

Enterprise Standard