GMP Factory Supply High purity Ademetionine 1,4-butanedisulfonate SAM Power for anti-depression

Item

Specification

Result

Test Method

Active Ingredeints

Assay(based on dried)

Succinic acid adenosine methionine95.0%~105.0%

98.40%

USP

Adenosine methionine cation50.0%~54.0%

51.80%

USP

Physical Control

Appearance 

White or off-white power with Hygroscopic 

Complies

Visual

Color

White 

Complies

Visual

Identification

Positive

Complies

HPLC,UV,IR

Specific rotation[a]020

+14.9°+28°~+34°+17.3°

 +31° 

USP

Color of Solution

NMT Y2 

Complies

USP

Clarity of Solution

NMT 1#

Complies

USP

Residue on ignition

0.1% Max(injection)  

0.2%Max(oral)

0.08%

USP

Wet

3.0%Max

2.60%

USP

PH

 1.8~2.5 

2.3

USP

Chemical Control

Heavy metals 

NMT10PPM

Conforms

CPh

Adenine

NMT0.5%

0.09%

CPh

S - adenosine - L homocysteine

NMT0.5%

0.05%

CPh

Aethylthioadenosine

NMT1%

0.23%

CPh

Succinic sulfonate(based on dried)

46.0%~49.0%

46.90%

CPh

(S) - S - adenosine methionine

60.0%~75.0%

71.20%

CPh

Impurity A  

NMT2%

1.20%

CPh

Impurity B

NMT0.5%

0.04%

CPh

Other individual impurity

NMT0.1%

0.07%

CPh

Other total impurity

NMT1.0%

0.15%

CPh

Total impurity

NMT3.0%

1.80%

CPh

Endotoxin

≤0.30 IU/mg

<0.02 IU/mg