| ≥1 piece |
|
TEM |
STANDARD |
RESULTS |
|
IDENTITY BY INFRARED |
CONFORMS TO STANDARD |
CONFORMS TO STANDARD |
|
ASSAY(DRY BASIS) |
98.0 TO 102.0% |
98.3% |
|
SPECIFIC ROTATION(20 C DRIED BASIS) |
-43.4 TO -40.0 DEGREES |
-41.2 DEGREES |
|
N-[N-(3,3-DIMETHYLBUTY1)-L-ALPHA-ASPARTY1]-L-PHENYLALANINE |
NMT 1.5% |
0.1% |
|
OTHER RELATED SUBSTANCES |
NMT 2.0% |
0.9% |
|
WATER |
NMT 5.0% |
4.3% |
|
LEAD |
NMT 2 PPM |
NMT 2 PPM |
|
ARSENIC |
NMT 3 PPM |
NMT 3 PPM |
|
RESIDUE ON IGNITION |
NMT 0.2% |
0.0% |
|
PH(05% SOLUTION) |
5.0 TO 7.0 |
5.5 |
|
RESIDUAL SOLVENTS |
PASS* * |
PASS* * |
|
AEROBIC PLATE COUNT |
NMT 250 PER GRAM |
NMT 250 PER GRAM |
|
COLIFORMS |
NMT 10 PER GRAM |
NMT 10 PER GRAM |
|
FUNGI |
NMT 100 PER GRAM |
NMT 100 PER GRAM |
|
MICROORGANISMS OF PUBLIC HEALTH CONCERN |
NONE DETECTED* * |
NONE DETECTED* * |