S-adenisyl-L-methionine disulfate p-toluenesulfonate(Same)

ITEMS

SPECIFICATION

Appearance

Almost white powder, hygroscopic，Soluble in Water

Identification

1)Chemical reaction

2)IR: Consistent with the spectrum obtained with reference Substance.

3)HPLC:The retention time of a major peak meets the requirements.

Acid value

1.0-2.0

Clarity and color of solution

Not more intensely colored than refrence Solution Y2

Heave metals

≤10ppm

Water

≤ 2.5%

S-adenosy1-L-Homocystein

≤ 0.5%

Methithioadenosine

≤ 2.0%

Adenine

≤ 0.5%

Related substance

The sum area of unknown impurities must be not more than 1.5 times of reference solution main peak’s(1.5%)

(S,S)Isomer

≥ 60.0%

Endotoxin

≤ 0.3EU/mg

Microbiological

≤ 1000CFU/

p-toluenesulfonatic acid

21.0%-24.0%(Base on dried)

Sulfates

23.5%-26.5%(Base on dried)

Ademetionine

≥ 49.5%(Base on dried)

Total content

≥ 96.0%