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DETAILS
FUNCTION
Application
COA| ITEMS | SPECIFICATION | RESULT | METHOD |
|---|---|---|---|
| Ratio | 10:1 | Conform | TLC || USP |
| I.D.-A Infrared absorption | Compare with the CRS | Conform | USP |
| I.D.-B General Sodium | Gives reaction of sodium | Conform | USP |
| I.D.-C Disaccharide Composition | △Di-4S / △Di-6S is NLT 1.0 | Conform | USP |
| I.D.-D Specific Rotation | Between –20.0° to –30.0° | Conform | USP |
| Content by CPC Titration | 90.0%-105.0% (dried basis) | Conform | USP |
| Content by HPLC | NLT 90.0% (dried basis) | Conform | In House Method |
| Residue On Ignition | 20.0%-30.0% | Conform | USP |
|---|---|---|---|
| Chloride | NMT 0.50% | Conform | USP |
| Sulfated Ash | NMT 0.24% | Conform | USP |
| Electrophoretic Purity | NMT 2.00% | Conform | USP |
| Limit Of Protein | NMT 6.00%(dried basis) | Conform | USP |
| Moisture | NMT 12.00% | Conform | USP |
| Nonspecific Dissaccharides | NLT 10.0% | Conform | USP |
| Clarity And Color Of Solution | NMT 0.35 at 420nm | Conform | USP |
| Optical Rotation | –20.0° to –30.0° | Conform | USP |
| pH | 5.5-7.5 | Conform | USP |
| Loss on Drying | NMT 12.0% | Conform | USP |
| Residue of Solvents | NMT 5,000 ppm (Ethanol) | Conform | USP |
| Particle Size | NLT 95% Through 80 mesh | Conform | USP |
| Bulk Density | 0.6g/mL-0.85g/ml | Conform | USP |
| Tapped Density | 0.65g/mL-1.20g/ml | Conform | USP |
| Pesticide Residue | Meet the requirements | Conform | GC || USP <561> |
|---|---|---|---|
| Heavy Metals(as Pb) | NMT 10ppm | Conform | USP <231> Method II |
| Arsenic (As) | NMT 1.5ppm | 0.740ppm | ICP-MS |
| Lead (Pb) | NMT 0.5ppm | Not Detected | ICP-MS |
| Cadmium (Cd) | NMT 0.5ppm | 0.420ppm | ICP-MS |
| Mercury (Hg) | NMT 0.3ppm | 0.021ppm | ICP-MS |
| Total Plate Count | NMT 1000cfu/g | 100cfu/g | USP |
|---|---|---|---|
| Total Yeast & Mold | NMT 100cfu/g | <100cfu/g | USP |
| E. Coli | Not Detected in(g) 10 | Not Detected | USP |
| Salmonella | Not Detected in(g) 25 | Not Detected | USP |
| Staphylococcus | Not Detected in(g) 10 | Not Detected | USP |
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