Modelo: USP
Items |
Specification |
Results |
Method |
Appearance |
Slight yellow crystal powder |
Conforms |
Organoleptic |
Identification |
Meet the requirements |
Conforms |
HPLC |
Melting point |
60~62 °C |
61.8°C |
USP |
Heavy metals |
10 ppm Max |
<10 ppm |
USP |
Lead |
3 ppm Max |
<3 ppm |
USP |
Cadmium |
1 ppm Max |
<1 ppm |
USP |
Mercury |
0.1 ppm Max |
<0.1 ppm |
USP |
Loss on drying |
0.2% Max |
0.14% |
USP |
Residue on ignition |
0.1% Max |
0.04% |
USP |
Specific Rotation |
-1.0°- +1.0° |
0° |
USP |
Limit of polymer content |
2% Max |
<2.0% |
TLC |
Related substance by HPLC | |||
6,8-Epitrithiooctanoic acid(EPI) |
0.10% Max |
0.02% |
HPLC |
Single impurity |
0.10% Max |
0.04% |
HPLC |
Total impurities |
0.50% Max |
0.06% |
HPLC |
Residual Solvent by GC | |||
Cyclohexane |
1000ppm Max |
919ppm |
GC |
Ethyl acetate |
250ppm Max |
78ppm |
GC |
Toluene |
20ppm Max |
Not detectable |
GC |
Total Plate Count |
1000 cfu/g Max |
<10cfu/g |
USP |
Moulds & Yeasts |
100cfu/g Max |
<10 cfu/g |
USP |
E. coli/ Salmonella |
Absence/g |
Not detectable |
USP |
Staphylococcus aureus |
Absence/g |
Not detectable |
USP |
Particle Size |
100% through 40 mesh |
Conforms |
USP |
Loose Bulk Density |
/ |
0.262 g/ml |
USP |
Assay |
99%~101% |
99.37% |
HPLC |
Conclusion |
Conformed USP32 |
Grupos de Producto : Aditivos alimentarios