|
ITEMS
|
SPECIFICATIONS
|
|
Appearance
|
White to off-white
hygroscopic powder
|
|
Identification (HPLC)
|
Positive
|
|
Solubility
|
Poorly soluble in
organic solvents; 1 g of SAM PTS completely solubilizes
in 2 ml water at room temp.
|
|
Moisture (K.F.)
|
2.5% Max.
|
|
pH (5% solution)
|
0.9 – 1.5
|
|
Heavy Metals
|
10 ppm Max.
|
|
Residue on Ignition
(on dry basis)
|
0.5% Max.
|
|
Related
Substances:
|
|
|
Adenosine
|
0.5 area% Max.
|
|
Adenine
|
0.5 area% Max.
|
|
5’deoxy 5’Methyl-thio
adenosine
|
0.5 area% Max.
|
|
S-Adenosil-L-homocysteine
|
0.5 area% Max.
|
|
L-Homoserine
|
0.5% Max.
|
|
2-Amino-4-butyrolactone
|
0.5% Max.
|
|
Total Impurities
|
3.0% Max.
|
|
Assay SAM ion
(on dry basis)
|
49.4 – 54.6%
|
|
Purity of SAM PTS
|
99.0% area% Min.
|
|
Enantiomers S,S
content
|
70.0% Min.
|
|
p-Toluenesulfonic Acid
(on dry basis)
|
21.3 – 23.6%
|
|
Sulfuric Acid (on dry
basis)
|
24.3 – 26.8%
|
|
Microbiology:
|
|
|
Total Bacterial Count
|
1,000 CFU/g Max.
|
|
Mycotic Count
|
100 CFU/g Max.
|
|
P. Aeruginosa
|
Absent / 1 g
|
|
E. Coli
|
Absent / 1 g
|
