| L-CITRULLINE |
| (Non-Sterile) |
| |
| BATCH NUMBER |
080101-01 |
MANUFACTURE DATE |
2008.01.20 |
| QUANTITY |
NA |
TEST DATE |
2008.01.23 |
| RETEST DATE |
2010-01 |
REPORT DATE |
2008.12.10 |
| |
| TEST |
SPECIFICATION |
RESULT |
|
| Appearance |
White crystalline powder |
Conforms |
|
| Identification |
HPLC |
Conforms |
|
| |
IR |
|
|
| Specific Rotation |
+ 24.5° ~ _ 26.8° |
+ 25.8° |
|
| Transmittance |
Note Less Than 98.0% |
99.3% |
|
| pH |
5.5~7.0 (10% Water Solution) |
5.9 |
|
| Heavy Metals |
Not More Than 10ppm |
<10ppm |
|
| Ammonium |
Not More Than 200ppm |
<200ppm |
|
| Loss on Drying |
Not More Than 0.30% |
0.02% |
|
| Residue on Ignition |
Not More Than 0.10% |
0.08% |
|
| Chloride |
Not More Than 200ppm |
<200ppm |
|
| Sulfate |
Not More Than 200ppm |
<200ppm |
|
| Iron |
Not More Than 10ppm |
<10ppm |
|
| Arsenic |
Not More Than 1ppm |
<1ppm |
|
| Assay (Calculated on dried basis) |
98.5~101.0% |
99.7% |
|
| Related Substances |
Ornithine: Not More Than 0.5% |
0.02% |
|
| |
Arginine: Not More Than 0.5% |
Not detected |
|
| |
Unknown Individual Impurity: Not More Than 0.1% |
0.01% |
|
| |
Total Impurities: Not More Than 1.0% |
0.03% |
|
| Microbial Limits |
Total Count of Aerobic: Not More Than 1000 CFU/g |
200CFU/g |
|
|
Fungi and Yeast: Not More Than 100 CFU/g |
<10CFU/g |
|
| |
Escherichia Coli: Absent/g |
Absent |
|
| |
|
|
