Test Item |
Specification |
Result |
Analytical Method Reference |
|
Appearance |
White or almost white crystalline powder |
White crystalline powder |
Visual |
|
Appearance of solution (10% w/v in water) |
Clear and colorless |
Complies |
Visual |
|
Bulk Density |
≥0.50 g/ml |
0.52 g/ml |
In-house |
|
Tapped Density |
≥0.60 g/ml |
0.65 g/ml |
In-house |
|
Particle Size |
100% thru mesh 80 |
Complies |
Mesh screen |
|
Identification |
S.O.R. |
-15.5° ~ -17.5° |
-16.0° |
USP <781S> |
Infrared |
Positive |
Positive |
USP <197K> |
|
Related |
L-glutathione oxidized |
≤1.5% |
0.3% |
Glutathione USP monograph |
Total impurities |
≤2.0% |
1.5% |
Glutathione USP monograph |
|
Assay(dry basis) |
98.0% to 101.0% |
100.3% |
Glutathione USP monograph |
|
Loss on drying(3 h at 105℃) |
≤0.5% |
0.3% |
USP <731> |
|
Residue on Ignition |
≤0.1% |
<0.1% |
USP <281> |
|
Ammonium |
≤200ppm |
﹤200ppm |
Glutathione USP monograph |
|
Chloride |
≤200ppm |
﹤200ppm |
USP <221> |
|
Sulfate |
≤300ppm |
﹤300ppm |
USP <221> |
|
Iron |
≤10ppm |
﹤10ppm |
USP <241> |
|
Arsenic |
≤1ppm |
<1ppm |
AFS |
|
Cadmium |
≤1ppm |
<1ppm |
AAS |
|
Lead |
≤1ppm |
<1ppm |
AAS |
|
Mercury |
≤1ppm |
<1ppm |
AFS |
|
Heavy metals |
≤10ppm |
<10ppm |
USP <231>Method I |
|
Total Plate Count |
≤1000 cfu/g |
<10 cfu/g |
USP <61> |
|
Yeast and Mold |
≤100 cfu/g |
25 cfu/g |
USP <61> |
|
Coliforms |
≤30 cfu/g |
<10 cfu/g |
USP <61> |
|
E. Coli |
Negative/g |
Negative |
USP <62> |
|
Salmonella |
Negative/10g |
Negative |
USP <62> |
|
Staphylococcus Aureus |
Negative/g |
Negative |
USP <62> |