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Date: 2024-05-05
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Lipoic Acid (Thioctic Acid)
CERTIFICATE OF ANALYSIS
| Alpha Lipoic Acid 99% |
|
DATE:Oct.27,2000 |
| Item |
Specifications |
RESULT |
RESULT |
RESULT |
RESULT |
RESULT |
|
| Batch No. |
|
020218 |
020219 |
020220 |
020221 |
020222 |
|
| Quantity |
|
100kgs |
100kgs |
100kgs |
100kgs |
100kgs |
|
| Description |
Light Yellow Crystalline powder |
complies |
Complies |
Complies |
Complies |
Complies |
|
| Identification |
Positive |
Positive |
Positive |
Positive |
Positive |
Positive |
|
| Melting point ℃ |
60°~ 62° |
62° |
61.9° |
61.9° |
61.9° |
62° |
|
| Solubility(In NaOH) |
Clear & Pale yellow |
complies |
Complies |
Complies |
Complies |
Complies |
|
| Residue on Ignition |
≤0.1% |
0.01% |
0.01% |
0.01% |
0.01% |
0.01% |
|
| Heavy Metals |
≤10ppm |
<10ppm |
<10ppm |
<10ppm |
<10ppm |
<10ppm |
|
| Loss on drying |
0.5% Max. |
0.23% |
0.13% |
0.20% |
0.15% |
0.23% |
|
| Assay (HPLC) |
99.5% Min. |
99.93% |
99.90% |
99.91% |
99.91% |
99.94% |
|
| Related substances (HPLC) |
|
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|
|
| Single Impurity |
≤0.20% |
0.16% |
0.18% |
0.17% |
0.18% |
0.16% |
|
| 6,8-Epitrithioctic acid |
≤0.3% |
0.28% |
0.28% |
0.27% |
0.27% |
0.28% |
|
| Total Impurities |
≤0.5% |
0.46% |
0.48% |
0.47% |
0.47% |
0.46% |
|
| Residueal solvents(GC) |
|
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|
|
|
|
|
| Toluene |
≤10ppm |
<5ppm |
<5ppm |
<5ppm |
<5ppm |
<5ppm |
|
| 1,2-Dichloroethane |
≤10ppm |
<5ppm |
<5ppm |
<5ppm |
<5ppm |
<5ppm |
|
| Cyclohexane |
≤2000ppm |
835ppm |
813ppm |
875ppm |
764ppm |
795ppm |
|
| Total plate count |
≤1000cfu/g |
<100cfu/g |
<100cfu/g |
<100cfu/g |
<100cfu/g |
<100cfu/g |
|
| Yeast & Mold |
<100cfu/g |
Not detected |
Not detected |
Not detected |
Not detected |
Not detected |
|
| E.Coli. |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
| Tested date: |
|
Feb. 19, 2002 |
Feb. 20, 2002 |
Feb. 20, 2002 |
Feb. 25, 2002 |
Feb. 26, 2002 |
|
| Director of quality control |
|
ZCM |
ZCM |
ZCM |
ZCM |
ZCM |
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