Ademetionine Disulfato Tosylate Igual CAS 97540-22-2

ITEM

STANDARD

APPEARANCE

     ALMOST WHITE POWDER,

HYGROSCOPIC.SOLUBLE IN WATER

IDENTIFICATION

1)CHEMICAL REACTION

2) IR: CONSISTENT WITH THE SPECTRUM OBTAINED WITH REFERENCE SUBATANCE.

3) HPLC: THE RETENTION TIME OF A MAJOR PEAK MEETS THE REQUIRMENTS.

ACID VALUE

1.0 ~ 2.0

CLARITY AND COLOR OF SOLUTION

NOT MORE INTENSELY COLRED THAN REFERENCE SOLUTION Y2

HEAVY METALS

N.M.T10PPM

WATER

N.M.T2.5%

S-ADENOSYL-L-HOMCYSTEIN

N.M.T0.5%

METHYLTHIOADENOSINE

N.M.T2.0%

ADENINE

N.M.T0.5%

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

N.L.T 62.0%

ENDOTOXIN

NMT 0.3 EU/mg

MICROBIOLOGICAL

NMT 1000CFU/g

P-TOLUENESULFONATIC ACID

21.0% ~ 24.0%(BASIS ON DRIED)

SULFATES

23.5%~ 26.5%(BASIS ON DRIED)

ADEMETIONINE

N.L.T49.5%(BASIS ON DRIED)

TOTAL CONTENT

N.L.T96.0%

Test  Item

Analysis  Specification

Result

Description

Almost white power, hygroscopic,

soluble in water

Confirmed

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

1.positive reaction

2 Confirmed

3.Confirmed

Acid value

1.0~2.0

1.5

Clarity and color of solution

Not more intensely colored than

reference solution Y2

Confirmed

Heavy metals

≤10ppm

<10ppm

Water

≤2.5%

1.2%

S-adenosyl-L-Homocystein

≤0.5%

0.01%

Methithioadenosine

≤2.0%

0.25%

Adenine

≤0.5%

0.15%

Related Substances

The sum area of unknown impurities must be not more than1.5times of reference solution main peak's (1.5%)

0.14%

(S,S)Isomer

≥60.0%

80.3%

Endotoxin

≤0.3EU/mg

Confirmed

Microbiological

≤1000CEU/mg

20CFU/g

p-toluenesulfonatic acid

21.0~24.0%(basis on dried)

23.1%

Sulfates

23.5~26.5%(basis on dried)

24.9%

Ademetionine

≥49.5%(basis on dried)

51.6%

Total content

≥96.0%

99.6%

Conclusion

Confirmed with the requirements.