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DETAILS
FUNCTION
Application
COA| ITEMS | SPECIFICATION | RESULT | METHOD |
|---|---|---|---|
| Calcium L-5-methyltetrahydrofolate (Anhydrous and solvent free) | 95.0~102.0% | 97.62% | HPLC || USP |
| L-5-Methyltetrahydrofolate (L-5-MTHF) | 72.0~87.0% | 82.27% | Calculation |
| Calcium (Anhydrous and solvent free) | 7.0~8.5% | 7.78% | Titrimetry|| USP |
| Total Related Compounds | NMT 2.5% | 0.36% | HPLC || USP |
| 4-Aminobenzoylglutamiv Acid | NMT 0.5% | Not Detected | HPLC || USP |
| 4a-Hydroxy-5-Methyltetrahydrofolic Acid | NMT 0.5% | 0.15% | HPLC || USP |
| (6R and 6S)-Mefox | NMT 1.0%(sum of 6R and 6S) | Not Detected | HPLC || USP |
| Tetrahydrofolic Acid | NMT 0.5% | Not Detected | HPLC || USP |
| 7,8-Dihydrofolic Acid | NMT 0.5% | Not Detected | HPLC || USP |
| Folic Acid | NMT 0.5% | Not Detected | HPLC || USP |
| 5,10-Methylenetetrahydrofolic Acid | NMT 0.5% | Not Detected | HPLC || USP |
| 5-Methylenetetrahydropteroic Acid | NMT 0.5% | 0.09% | HPLC || USP |
| Dimethyltetrahydrofolic Acid | NMT 0.15% | Not Detected | HPLC || USP |
| Enantiomeric Purity (D-5-Methyltetrahydrofolate) | NMT 1.0% | 0.5% | HPLC || USP |
| Identification | The retention time of the principle peak should conform with standard | Conform | HPLC || USP |
| Water Determination (K-F) | 6.0~17.0% | 8.43% | USP Method Ic |
|---|---|---|---|
| Particle Size | NLT 90% Through 80 mesh | Conform | Analytical sieving || USP |
| Bulk Density | NLT 0.2g/ml | 0.21g/ml | USP Method I |
| Residual Solvent | Ethanol: NMT 5,000ppm | Not Detected | GC || USP |
|---|---|---|---|
| 2-Propanol: NMT 5,000ppm | Not Detected | GC || USP | |
| Platinium | NMT 10ppm | <0.01ppm | ICP-MS || USP |
| Boron | NMT 50ppm | 13.2ppm | ICP-MS || USP |
| Chloride | NMT 0.5% | 0.15% | Titrimetry|| USP |
| Heavy Metals(as Pb) | NMT 20ppm | Conform | USP Method II |
| Arsenic (As) | NMT 1.5ppm | 0.01ppm | ICP-MS || USP |
| Lead (Pb) | NMT 1.0ppm | Not Detected | ICP-MS || USP |
| Cadmium (Cd) | NMT 0.5ppm | Not Detected | ICP-MS || USP |
| Mercury (Hg) | NMT 1.5ppm | Not Detected | ICP-MS || USP |
| Total Plate Count | NMT 5,000cfu/g | <10cfu/g | USP |
|---|---|---|---|
| Total Yeast & Mold | NMT 500cfu/g | <10cfu/g | USP |
| E. Coli | Not Detected in(g) 10 | Not Detected | USP |
| Salmonella | Not Detected in(g) 25 | Not Detected | USP |
| Staphylococcus aureus | Not Detected in(g) 10 | Not Detected | USP |
| Pseudomonas aeruginosa | Not Detected in(g) 10 | Not Detected | USP |
| Candida albicans | Not Detected in(g) 10 | Not Detected | USP |
| Clostridia | Not Detected in(g) 10 | Not Detected | USP |
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